<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04487158</url>
  </required_header>
  <id_info>
    <org_study_id>H19-02665</org_study_id>
    <nct_id>NCT04487158</nct_id>
  </id_info>
  <brief_title>Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A Weight Loss Trial</brief_title>
  <acronym>INSPIRE</acronym>
  <official_title>Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A 12 Month Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to compare short- and long-term changes in body weight (kg) and&#xD;
      subjective well-being in adult females with obesity who have been randomized to receive one&#xD;
      of two 6-month treatment conditions: INSPIRE or Small Changes. The Small Changes approach is&#xD;
      an evidence-based behavioural weight management program that uses relative and modest changes&#xD;
      in nutrition and physical activity to produce a caloric deficit. The INSPIRE program is a&#xD;
      modification of the Small Changes program that spends the first four weeks on improving&#xD;
      well-being via psychological interventions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rates of obesity continues to rise in Canada and worldwide, which is related to the presence&#xD;
      and increased severity of multiple co-morbid illnesses as well as a reduction in overall&#xD;
      quality and quantity of life. Traditional behavioural interventions have demonstrated&#xD;
      efficacy in producing initial weight loss; however, a continued challenge for these programs&#xD;
      is long-term weight loss maintenance. The Small Changes program is an alternative approach to&#xD;
      weight loss that encourages modest changes to nutrition and physical activity that are&#xD;
      sustainable long-term. Although promising, this approach has failed to consistently&#xD;
      demonstrate clinically significant weight loss. It has been suggested that psychological&#xD;
      factors, such as low levels of subjective well-being (negative affect, positive affect, and&#xD;
      life satisfaction), may work in opposition of an individual's weight management goals. Thus,&#xD;
      the integration of psychological interventions with a Small Changes approach has the&#xD;
      potential to improve well-being and weight loss concurrently. Based on previous research,&#xD;
      psychological interventions may be effectively utilized if they are implemented at the&#xD;
      beginning of an intervention where early changes in well-being promote greater adherence to&#xD;
      health behaviour change. To date, no behavioural intervention that integrates psychological&#xD;
      approaches at treatment outset has been evaluated. The primary aim of the study is to&#xD;
      determine the feasibility, acceptability, and efficacy of a novel group-based integrative&#xD;
      behavioural and psychological intervention (INSPIRE) on change in weight and subjective&#xD;
      well-being outcomes compared to an evidence-based behavioural intervention for weight loss&#xD;
      (Small Changes).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 22, 2019</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline weight (self-report)</measure>
    <time_frame>3 months</time_frame>
    <description>(kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline weight (self-report)</measure>
    <time_frame>6 months</time_frame>
    <description>(kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline weight</measure>
    <time_frame>9 months</time_frame>
    <description>(kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline weight</measure>
    <time_frame>12 months</time_frame>
    <description>(kg)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the Satisfaction with Life Scale</measure>
    <time_frame>3 months</time_frame>
    <description>The Satisfaction with Life Scale is 5-item questionnaire used to assess life satisfaction which is a component of subjective well-being. Total scores range from 5 to 35 with higher scores indicating greater life satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the Satisfaction with Life Scale</measure>
    <time_frame>6 months</time_frame>
    <description>The Satisfaction with Life Scale is 5-item questionnaire used to assess life satisfaction which is a component of subjective well-being. Total scores range from 5 to 35 with higher scores indicating greater life satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the Satisfaction with Life Scale</measure>
    <time_frame>12 months</time_frame>
    <description>The Satisfaction with Life Scale is 5-item questionnaire used to assess life satisfaction which is a component of subjective well-being. Total scores range from 5 to 35 with higher scores indicating greater life satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the Scale of Positive and Negative Experiences</measure>
    <time_frame>3 months</time_frame>
    <description>The Scale of Positive and Negative Experiences 12-item self-report measure that will be used to measure two components of subjective well-being (positive affect and negative affect). The 12-items load onto two sub-scales: one pertaining to Positive Affect and the other pertaining to Negative Affect. Both subscales range from 6 to 30. Higher scores on these two sub-scales indicate greater experiences of either positive or negative affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the Scale of Positive and Negative Experiences (SPANE)</measure>
    <time_frame>6 months</time_frame>
    <description>The Scale of Positive and Negative Experiences is 12-item self-report measure that will be used to measure two components of subjective well-being (positive affect and negative affect). The 12-items load onto two sub-scales: one pertaining to Positive Affect and the other pertaining to Negative Affect. Both subscales range from 6 to 30. Higher scores on these two sub-scales indicate greater experiences of either positive or negative affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline on the Scale of Positive and Negative Experiences (SPANE)</measure>
    <time_frame>12 months</time_frame>
    <description>The Scale of Positive and Negative Experiences is 12-item self-report measure that will be used to measure two components of subjective well-being (positive affect and negative affect). The 12-items load onto two sub-scales: one pertaining to Positive Affect and the other pertaining to Negative Affect. Both subscales range from 6 to 30. Higher scores on these two sub-scales indicate greater experiences of either positive or negative affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from Baseline in Waist Circumference</measure>
    <time_frame>9 months</time_frame>
    <description>(cm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Waist Circumference</measure>
    <time_frame>12 months</time_frame>
    <description>(cm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Blood Pressure</measure>
    <time_frame>9 months</time_frame>
    <description>Systolic and Diastolic Blood Pressure</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Blood Pressure</measure>
    <time_frame>12 months</time_frame>
    <description>Systolic and Diastolic Blood Pressure</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Heart Rate</measure>
    <time_frame>9 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Heart Rate</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Self-Compassion Scale</measure>
    <time_frame>3 months</time_frame>
    <description>The Self-Compassion Scale is a 26-item self-report measure which will be used to measure how an individual responds and acts towards themselves during difficult times. Total score ranges from 5 to 30 with higher scores indicating greater self-compassion.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Self-Compassion Scale</measure>
    <time_frame>6 months</time_frame>
    <description>The Self-Compassion Scale is a 26-item self-report measure which will be used to measure how an individual responds and acts towards themselves during difficult times. Total score ranges from 5 to 30 with higher scores indicating greater self-compassion.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Self-Compassion Scale</measure>
    <time_frame>12 months</time_frame>
    <description>The elf-Compassion Scale is a 26-item self-report measure which will be used to measure how an individual responds and acts towards themselves during difficult times. Total score ranges from 5 to 30 with higher scores indicating greater self-compassion.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the New General Self-Efficacy Scale</measure>
    <time_frame>3 months</time_frame>
    <description>The New General Self-Efficacy is an 8-item self-report questionnaire that will be used to measure general self-efficacy. Total scores range from 8 to 40 with higher scores indicating greater general self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the New General Self-Efficacy Scale</measure>
    <time_frame>6 months</time_frame>
    <description>The New General Self-Efficacy is an 8-item self-report questionnaire that will be used to measure general self-efficacy. Total scores range from 8 to 40 with higher scores indicating greater general self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the New General Self-Efficacy Scale</measure>
    <time_frame>12 months</time_frame>
    <description>The New General Self-Efficacy is an 8-item self-report questionnaire that will be used to measure general self-efficacy. Total scores range from 8 to 40 with higher scores indicating greater general self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Self-Efficacy for Exercise Scale</measure>
    <time_frame>3 months</time_frame>
    <description>The Self-Efficacy for Exercise Scale is a 9-item self-report questionnaire that will be used to measure self-efficacy for exercise. Total scores range from 0 to 90 with higher scores representative of greater exercise-related self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Self-Efficacy for Exercise Scale</measure>
    <time_frame>6 months</time_frame>
    <description>The Self-Efficacy for Exercise Scale is a 9-item self-report questionnaire that will be used to measure self-efficacy for exercise. Total scores range from 0 to 90 with higher scores representative of greater exercise-related self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Self-Efficacy for Exercise Scale</measure>
    <time_frame>12 months</time_frame>
    <description>The Self-Efficacy for Exercise Scale is a 9-item self-report questionnaire that will be used to measure self-efficacy for exercise. Total scores range from 0 to 90 with higher scores representative of greater exercise-related self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Weight Efficacy Lifestyle Questionnaire Short-Form</measure>
    <time_frame>3 months</time_frame>
    <description>The Weight Efficacy Lifestyle Questionnaire Short-Form will be used to measure a specific form of self-efficacy related to eating habits. The WEL-SF is an 8-item measure with total scores ranging from 0 to 80 where higher scores are indicative of greater self-efficacy for eating habits.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Weight Efficacy Lifestyle Questionnaire Short-Form</measure>
    <time_frame>6 months</time_frame>
    <description>The Weight Efficacy Lifestyle Questionnaire Short-Form will be used to measure a specific form of self-efficacy related to eating habits. The WEL-SF is an 8-item measure with total scores ranging from 0 to 80 where higher scores are indicative of greater self-efficacy for eating habits.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Weight Efficacy Lifestyle Questionnaire Short-Form</measure>
    <time_frame>12 months</time_frame>
    <description>The Weight Efficacy Lifestyle Questionnaire Short-Form will be used to measure a specific form of self-efficacy related to eating habits. The WEL-SF is an 8-item measure with total scores ranging from 0 to 80 where higher scores are indicative of greater self-efficacy for eating habits.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Three Factor Eating Questionnaire-Revised</measure>
    <time_frame>3 months</time_frame>
    <description>The Three Factor Eating Questionnaire-Revised is an 18-item self-report measure of the cognitive and behavioural components of eating across three factors: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Each subscale ranges from 1 to 4 (mean of all item on each subscale) with higher scores indicating greater endorsement of the subscale domain. Higher scores on the Cognitive Restraint represent greater cognitive restraint. Higher scores on the Uncontrolled subscale represent greater experiences with uncontrolled eating. Higher scores on the Emotional Eating subscale represent greater experiences with emotional eating.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Three Factor Eating Questionnaire-Revised</measure>
    <time_frame>6 months</time_frame>
    <description>The Three Factor Eating Questionnaire-Revised is an 18-item self-report measure of the cognitive and behavioural components of eating across three factors: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Each subscale ranges from 1 to 4 (mean of all item on each subscale) with higher scores indicating greater endorsement of the subscale domain. Higher scores on the Cognitive Restraint represent greater cognitive restraint. Higher scores on the Uncontrolled subscale represent greater experiences with uncontrolled eating. Higher scores on the Emotional Eating subscale represent greater experiences with emotional eating.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Three Factor Eating Questionnaire-Revised</measure>
    <time_frame>12 months</time_frame>
    <description>The Three Factor Eating Questionnaire-Revised is an 18-item self-report measure of the cognitive and behavioural components of eating across three factors: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Each subscale ranges from 1 to 4 (mean of all item on each subscale) with higher scores indicating greater endorsement of the subscale domain. Higher scores on the Cognitive Restraint represent greater cognitive restraint. Higher scores on the Uncontrolled subscale represent greater experiences with uncontrolled eating. Higher scores on the Emotional Eating subscale represent greater experiences with emotional eating.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Food Cravings Inventory</measure>
    <time_frame>3 months</time_frame>
    <description>The Food Cravings Inventory is a 33-item self-report measure of food cravings. Total score ranges from 33 to 165 with higher scores indicative of greater food cravings.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Food Cravings Inventory</measure>
    <time_frame>6 months</time_frame>
    <description>The Food Cravings Inventory is a 33-item self-report measure of food cravings. Total score ranges from 33 to 165 with higher scores indicative of greater food cravings.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Food Cravings Inventory</measure>
    <time_frame>12 months</time_frame>
    <description>The Food Cravings Inventory is a 33-item self-report measure of food cravings. Total score ranges from 33 to 165 with higher scores indicative of greater food cravings.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on Objective Mean Step Count across 7 days</measure>
    <time_frame>3 months</time_frame>
    <description>Step count from pedometers will be recorded daily and averaged across each week.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Body Shape Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>The Body Shape Questionnaire is a 34-item self-report questionnaire of cognitively-based body dissatisfaction. Total scores range from 34 to 170 with higher scores indicative of greater body dissatisfaction.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Body Shape Questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>The Body Shape Questionnaire is a 34-item self-report questionnaire of cognitively-based body dissatisfaction. Total scores range from 34 to 170 with higher scores indicative of greater body dissatisfaction.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline on the Body Shape Questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>The Body Shape Questionnaire is a 34-item self-report questionnaire of cognitively-based body dissatisfaction. Total scores range from 34 to 170 with higher scores indicative of greater body dissatisfaction.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Resting Metabolic Rate</measure>
    <time_frame>9 months</time_frame>
    <description>Resting Metabolic Rate will be reported as kcal/day measured by indirect calorimetry</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from Baseline in Resting Metabolic Rate</measure>
    <time_frame>12 months</time_frame>
    <description>Resting Metabolic Rate will be reported as kcal/day measured by indirect calorimetry</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Small Changes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>INSPIRE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Small Changes</intervention_name>
    <description>The Small Changes program is an evidence-based 6-month weight-management program. The program runs weekly for 3 months followed by by-weekly contact for 3-months (1x in-person group and 1x phone call). This program uses behaviour change strategies to help with weight loss. The Small Changes approach is different from traditional dieting programs because it encourages modest changes to diet and physical activity which are not overly taxing to maintain. Participants are asked to reduce their nutritional intake by 200-400 calories per day. You will also be asked to increase their daily step count by 2000-3000 steps. Weekly intervention topics include: Monitoring, Nutrition, Physical Activity, Breaking the Chain, External Cues, Mindful Eating, Body Image, Stress, Sleep, Social Support, Social Eating, and the Stoplight Guide.</description>
    <arm_group_label>Small Changes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>INSPIRE</intervention_name>
    <description>The INSPIRE program is a modification to the Small Changes program. It combines elements of positive psychology and behaviour change to help with weight loss. The first four weeks of the program are oriented towards improving well-being and include topics such as values, self-compassion/mindfulness, character strengths, and gratitude. The remaining 8 weeks mirrors the Small Changes program in making modest changes to diet and physical activity to achieve weight loss. Participants are asked to reduce their nutritional intake by 200-400 calories per day. Participants will also be asked to increase their daily step count by 2000-3000 steps.</description>
    <arm_group_label>INSPIRE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female between the ages of 25 to 75&#xD;
&#xD;
          -  BMI between 30 and 45&#xD;
&#xD;
          -  Not currently participating in any other weight management programs&#xD;
&#xD;
          -  Self-reports wanting to lose weight&#xD;
&#xD;
          -  Willing to follow recommendations in the study protocol and attend weekly group&#xD;
             intervention for 12 weeks and a 3-month follow-up group (one in-person group per month&#xD;
             and one phone call per month)&#xD;
&#xD;
          -  Ability to attend 4 assessment appointments over the course of the study period (at&#xD;
             baseline, 3-months, 6-months, 12-months).&#xD;
&#xD;
          -  Willing to be randomized into any of the two study arms and willing to adhere to&#xD;
             guidelines and recommendations associated with the study arm they are randomized into&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot commit to weekly group times. Participants must be available for at least one&#xD;
             group time of each intervention arm in order to be eligible to participate.&#xD;
&#xD;
          -  Participated in a weight loss intervention in the past six months&#xD;
&#xD;
          -  Participants who are pregnant (or less than 6 months post partum) or planning to&#xD;
             become pregnant in the next 12 months&#xD;
&#xD;
          -  Weight loss of &gt; 5kg (~11 lb) in the previous 6 months&#xD;
&#xD;
          -  History of, or current, clinically diagnosed eating disorder or exhibiting clinical&#xD;
             symptoms of an eating disorder but undiagnosed (EDE-Q ≥ 4.0 unless clinical judgement&#xD;
             indicates otherwise)&#xD;
&#xD;
          -  Reported health problems that make weight loss or unsupervised exercise unsafe or&#xD;
             unreasonable (as measured by the PAR-Q+) where a doctor's note is not provided&#xD;
&#xD;
          -  Resting systolic blood pressure &gt;160 mmHg or resting diastolic blood pressure &gt;100&#xD;
             mmHg&#xD;
&#xD;
          -  If any of the following medical conditions are present: Insulin dependent diabetes;&#xD;
             Previous surgical procedure for weight loss; Major surgery within the previous 6&#xD;
             months; A history of heart problems (e.g., angina, bypass surgery, myocardial&#xD;
             infarction) within the previous 6 months; Implanted cardiac defibrillator or&#xD;
             pacemaker; Currently (or within the past 5 years) being treated for cancer;&#xD;
             Inflammatory Bowel Disease (i.e., chronic inflammatory gastrointestinal disease such&#xD;
             as Crohn's Disease or Ulcerative Colitis); Chronic Pain (e.g., fibromyalgia) that&#xD;
             would prevent the participant from engaging in physical activity&#xD;
&#xD;
          -  The participant is currently experiencing elevated symptoms of depression&#xD;
&#xD;
          -  The participant is planning to move within the study period&#xD;
&#xD;
          -  The participant consumes more than 14 alcoholic drinks per week or more than 3 drinks&#xD;
             per day&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-identify as female</gender_description>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lesley Lutes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia- Okanagan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of British Columbia Okanagan</name>
      <address>
        <city>Kelowna</city>
        <state>British Columbia</state>
        <zip>V1V2J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Lesley Lutes</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Behavioral Intervention</keyword>
  <keyword>Psychological Intervention</keyword>
  <keyword>Weight Management</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04487158
org study id: H19-02665
nct id: NCT04487158
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is designed to compare short- and long-term changes in body weight (kg) and
      subjective well-being in adult females with obesity who have been randomized to receive one
      of two 6-month treatment conditions: INSPIRE or Small Changes. The Small Changes approach is
      an evidence-based behavioural weight management program that uses relative and modest changes
      in nutrition and physical activity to produce a caloric deficit. The INSPIRE program is a
      modification of the Small Changes program that spends the first four weeks on improving
      well-being via psychological interventions.
Rates of obesity continues to rise in Canada and worldwide, which is related to the presence
      and increased severity of multiple co-morbid illnesses as well as a reduction in overall
      quality and quantity of life. Traditional behavioural interventions have demonstrated
      efficacy in producing initial weight loss; however, a continued challenge for these programs
      is long-term weight loss maintenance. The Small Changes program is an alternative approach to
      weight loss that encourages modest changes to nutrition and physical activity that are
      sustainable long-term. Although promising, this approach has failed to consistently
      demonstrate clinically significant weight loss. It has been suggested that psychological
      factors, such as low levels of subjective well-being (negative affect, positive affect, and
      life satisfaction), may work in opposition of an individual's weight management goals. Thus,
      the integration of psychological interventions with a Small Changes approach has the
      potential to improve well-being and weight loss concurrently. Based on previous research,
      psychological interventions may be effectively utilized if they are implemented at the
      beginning of an intervention where early changes in well-being promote greater adherence to
      health behaviour change. To date, no behavioural intervention that integrates psychological
      approaches at treatment outset has been evaluated. The primary aim of the study is to
      determine the feasibility, acceptability, and efficacy of a novel group-based integrative
      behavioural and psychological intervention (INSPIRE) on change in weight and subjective
      well-being outcomes compared to an evidence-based behavioural intervention for weight loss
      (Small Changes).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline weight (self-report)
time frame: 3 months
description: (kg)
measure: Change from baseline weight (self-report)
time frame: 6 months
description: (kg)
measure: Change from baseline weight
time frame: 9 months
description: (kg)
measure: Change from baseline weight
time frame: 12 months
description: (kg)
measure: Change from Baseline on the Satisfaction with Life Scale
time frame: 3 months
description: The Satisfaction with Life Scale is 5-item questionnaire used to assess life satisfaction which is a component of subjective well-being. Total scores range from 5 to 35 with higher scores indicating greater life satisfaction.
measure: Change from Baseline on the Satisfaction with Life Scale
time frame: 6 months
description: The Satisfaction with Life Scale is 5-item questionnaire used to assess life satisfaction which is a component of subjective well-being. Total scores range from 5 to 35 with higher scores indicating greater life satisfaction.
measure: Change from Baseline on the Satisfaction with Life Scale
time frame: 12 months
description: The Satisfaction with Life Scale is 5-item questionnaire used to assess life satisfaction which is a component of subjective well-being. Total scores range from 5 to 35 with higher scores indicating greater life satisfaction.
measure: Change from Baseline on the Scale of Positive and Negative Experiences
time frame: 3 months
description: The Scale of Positive and Negative Experiences 12-item self-report measure that will be used to measure two components of subjective well-being (positive affect and negative affect). The 12-items load onto two sub-scales: one pertaining to Positive Affect and the other pertaining to Negative Affect. Both subscales range from 6 to 30. Higher scores on these two sub-scales indicate greater experiences of either positive or negative affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions).
measure: Change from Baseline on the Scale of Positive and Negative Experiences (SPANE)
time frame: 6 months
description: The Scale of Positive and Negative Experiences is 12-item self-report measure that will be used to measure two components of subjective well-being (positive affect and negative affect). The 12-items load onto two sub-scales: one pertaining to Positive Affect and the other pertaining to Negative Affect. Both subscales range from 6 to 30. Higher scores on these two sub-scales indicate greater experiences of either positive or negative affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions).
measure: Change from Baseline on the Scale of Positive and Negative Experiences (SPANE)
time frame: 12 months
description: The Scale of Positive and Negative Experiences is 12-item self-report measure that will be used to measure two components of subjective well-being (positive affect and negative affect). The 12-items load onto two sub-scales: one pertaining to Positive Affect and the other pertaining to Negative Affect. Both subscales range from 6 to 30. Higher scores on these two sub-scales indicate greater experiences of either positive or negative affect states (i.e., higher scores on the SPANE-PA scale indicates greater frequency of experiencing positive emotions).
measure: Change from Baseline in Waist Circumference
time frame: 9 months
description: (cm)
measure: Change from Baseline in Waist Circumference
time frame: 12 months
description: (cm)
measure: Change from Baseline in Blood Pressure
time frame: 9 months
description: Systolic and Diastolic Blood Pressure
measure: Change from Baseline in Blood Pressure
time frame: 12 months
description: Systolic and Diastolic Blood Pressure
measure: Change from Baseline in Heart Rate
time frame: 9 months
measure: Change from Baseline in Heart Rate
time frame: 12 months
measure: Change from Baseline on the Self-Compassion Scale
time frame: 3 months
description: The Self-Compassion Scale is a 26-item self-report measure which will be used to measure how an individual responds and acts towards themselves during difficult times. Total score ranges from 5 to 30 with higher scores indicating greater self-compassion.
measure: Change from Baseline on the Self-Compassion Scale
time frame: 6 months
description: The Self-Compassion Scale is a 26-item self-report measure which will be used to measure how an individual responds and acts towards themselves during difficult times. Total score ranges from 5 to 30 with higher scores indicating greater self-compassion.
measure: Change from Baseline on the Self-Compassion Scale
time frame: 12 months
description: The elf-Compassion Scale is a 26-item self-report measure which will be used to measure how an individual responds and acts towards themselves during difficult times. Total score ranges from 5 to 30 with higher scores indicating greater self-compassion.
measure: Change from Baseline on the New General Self-Efficacy Scale
time frame: 3 months
description: The New General Self-Efficacy is an 8-item self-report questionnaire that will be used to measure general self-efficacy. Total scores range from 8 to 40 with higher scores indicating greater general self-efficacy.
measure: Change from Baseline on the New General Self-Efficacy Scale
time frame: 6 months
description: The New General Self-Efficacy is an 8-item self-report questionnaire that will be used to measure general self-efficacy. Total scores range from 8 to 40 with higher scores indicating greater general self-efficacy.
measure: Change from Baseline on the New General Self-Efficacy Scale
time frame: 12 months
description: The New General Self-Efficacy is an 8-item self-report questionnaire that will be used to measure general self-efficacy. Total scores range from 8 to 40 with higher scores indicating greater general self-efficacy.
measure: Change from Baseline on the Self-Efficacy for Exercise Scale
time frame: 3 months
description: The Self-Efficacy for Exercise Scale is a 9-item self-report questionnaire that will be used to measure self-efficacy for exercise. Total scores range from 0 to 90 with higher scores representative of greater exercise-related self-efficacy.
measure: Change from Baseline on the Self-Efficacy for Exercise Scale
time frame: 6 months
description: The Self-Efficacy for Exercise Scale is a 9-item self-report questionnaire that will be used to measure self-efficacy for exercise. Total scores range from 0 to 90 with higher scores representative of greater exercise-related self-efficacy.
measure: Change from Baseline on the Self-Efficacy for Exercise Scale
time frame: 12 months
description: The Self-Efficacy for Exercise Scale is a 9-item self-report questionnaire that will be used to measure self-efficacy for exercise. Total scores range from 0 to 90 with higher scores representative of greater exercise-related self-efficacy.
measure: Change from Baseline on the Weight Efficacy Lifestyle Questionnaire Short-Form
time frame: 3 months
description: The Weight Efficacy Lifestyle Questionnaire Short-Form will be used to measure a specific form of self-efficacy related to eating habits. The WEL-SF is an 8-item measure with total scores ranging from 0 to 80 where higher scores are indicative of greater self-efficacy for eating habits.
measure: Change from Baseline on the Weight Efficacy Lifestyle Questionnaire Short-Form
time frame: 6 months
description: The Weight Efficacy Lifestyle Questionnaire Short-Form will be used to measure a specific form of self-efficacy related to eating habits. The WEL-SF is an 8-item measure with total scores ranging from 0 to 80 where higher scores are indicative of greater self-efficacy for eating habits.
measure: Change from Baseline on the Weight Efficacy Lifestyle Questionnaire Short-Form
time frame: 12 months
description: The Weight Efficacy Lifestyle Questionnaire Short-Form will be used to measure a specific form of self-efficacy related to eating habits. The WEL-SF is an 8-item measure with total scores ranging from 0 to 80 where higher scores are indicative of greater self-efficacy for eating habits.
measure: Change from Baseline on the Three Factor Eating Questionnaire-Revised
time frame: 3 months
description: The Three Factor Eating Questionnaire-Revised is an 18-item self-report measure of the cognitive and behavioural components of eating across three factors: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Each subscale ranges from 1 to 4 (mean of all item on each subscale) with higher scores indicating greater endorsement of the subscale domain. Higher scores on the Cognitive Restraint represent greater cognitive restraint. Higher scores on the Uncontrolled subscale represent greater experiences with uncontrolled eating. Higher scores on the Emotional Eating subscale represent greater experiences with emotional eating.
measure: Change from Baseline on the Three Factor Eating Questionnaire-Revised
time frame: 6 months
description: The Three Factor Eating Questionnaire-Revised is an 18-item self-report measure of the cognitive and behavioural components of eating across three factors: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Each subscale ranges from 1 to 4 (mean of all item on each subscale) with higher scores indicating greater endorsement of the subscale domain. Higher scores on the Cognitive Restraint represent greater cognitive restraint. Higher scores on the Uncontrolled subscale represent greater experiences with uncontrolled eating. Higher scores on the Emotional Eating subscale represent greater experiences with emotional eating.
measure: Change from Baseline on the Three Factor Eating Questionnaire-Revised
time frame: 12 months
description: The Three Factor Eating Questionnaire-Revised is an 18-item self-report measure of the cognitive and behavioural components of eating across three factors: Cognitive Restraint, Uncontrolled Eating, and Emotional Eating. Each subscale ranges from 1 to 4 (mean of all item on each subscale) with higher scores indicating greater endorsement of the subscale domain. Higher scores on the Cognitive Restraint represent greater cognitive restraint. Higher scores on the Uncontrolled subscale represent greater experiences with uncontrolled eating. Higher scores on the Emotional Eating subscale represent greater experiences with emotional eating.
measure: Change from Baseline on the Food Cravings Inventory
time frame: 3 months
description: The Food Cravings Inventory is a 33-item self-report measure of food cravings. Total score ranges from 33 to 165 with higher scores indicative of greater food cravings.
measure: Change from Baseline on the Food Cravings Inventory
time frame: 6 months
description: The Food Cravings Inventory is a 33-item self-report measure of food cravings. Total score ranges from 33 to 165 with higher scores indicative of greater food cravings.
measure: Change from Baseline on the Food Cravings Inventory
time frame: 12 months
description: The Food Cravings Inventory is a 33-item self-report measure of food cravings. Total score ranges from 33 to 165 with higher scores indicative of greater food cravings.
measure: Change from Baseline on Objective Mean Step Count across 7 days
time frame: 3 months
description: Step count from pedometers will be recorded daily and averaged across each week.
measure: Change from Baseline on the Body Shape Questionnaire
time frame: 3 months
description: The Body Shape Questionnaire is a 34-item self-report questionnaire of cognitively-based body dissatisfaction. Total scores range from 34 to 170 with higher scores indicative of greater body dissatisfaction.
measure: Change from Baseline on the Body Shape Questionnaire
time frame: 6 months
description: The Body Shape Questionnaire is a 34-item self-report questionnaire of cognitively-based body dissatisfaction. Total scores range from 34 to 170 with higher scores indicative of greater body dissatisfaction.
measure: Change from Baseline on the Body Shape Questionnaire
time frame: 12 months
description: The Body Shape Questionnaire is a 34-item self-report questionnaire of cognitively-based body dissatisfaction. Total scores range from 34 to 170 with higher scores indicative of greater body dissatisfaction.
measure: Change from Baseline in Resting Metabolic Rate
time frame: 9 months
description: Resting Metabolic Rate will be reported as kcal/day measured by indirect calorimetry
measure: Change from Baseline in Resting Metabolic Rate
time frame: 12 months
description: Resting Metabolic Rate will be reported as kcal/day measured by indirect calorimetry
arm group label: Small Changes
arm group type: Active Comparator
arm group label: INSPIRE
arm group type: Experimental
intervention type: Behavioral
intervention name: Small Changes
description: The Small Changes program is an evidence-based 6-month weight-management program. The program runs weekly for 3 months followed by by-weekly contact for 3-months (1x in-person group and 1x phone call). This program uses behaviour change strategies to help with weight loss. The Small Changes approach is different from traditional dieting programs because it encourages modest changes to diet and physical activity which are not overly taxing to maintain. Participants are asked to reduce their nutritional intake by 200-400 calories per day. You will also be asked to increase their daily step count by 2000-3000 steps. Weekly intervention topics include: Monitoring, Nutrition, Physical Activity, Breaking the Chain, External Cues, Mindful Eating, Body Image, Stress, Sleep, Social Support, Social Eating, and the Stoplight Guide.
arm group label: Small Changes
intervention type: Behavioral
intervention name: INSPIRE
description: The INSPIRE program is a modification to the Small Changes program. It combines elements of positive psychology and behaviour change to help with weight loss. The first four weeks of the program are oriented towards improving well-being and include topics such as values, self-compassion/mindfulness, character strengths, and gratitude. The remaining 8 weeks mirrors the Small Changes program in making modest changes to diet and physical activity to achieve weight loss. Participants are asked to reduce their nutritional intake by 200-400 calories per day. Participants will also be asked to increase their daily step count by 2000-3000 steps.
arm group label: INSPIRE
criteria: 
gender: Female
gender based: Yes
gender description: Self-identify as female
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
last name: Lesley Lutes, PhD
role: Principal Investigator
affiliation: University of British Columbia- Okanagan
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Lesley Lutes
investigator title: Professor
sharing ipd: No