<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/NCT03037567</url>
  </required_header>
  <id_info>
    <org_study_id>16-3421</org_study_id>
    <nct_id>NCT03037567</nct_id>
  </id_info>
  <brief_title>Evaluation of a Commercial Program on Weight Loss and Health Outcomes</brief_title>
  <official_title>Evaluation of a Commercial Program on Weight Loss and Health Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Weight Watchers International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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 purpose of this study is to examine the acceptability and efficacy of a modified Weight&#xD;
      Watchers program over 24 weeks. Assessments will be conducted at 0, 3, and 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The following assessment measures will be taken at 0, 3, and 6 months:&#xD;
&#xD;
      Weight measurements. Weight will be taken according to the National Health and Nutrition&#xD;
      Examination survey anthropometry procedures manual. Weight will be measured in kilograms to&#xD;
      the nearest 0.1 kg using a calibrated digital scale (Tanita, Inc.) with participants in light&#xD;
      clothing and no shoes. Two measurements will be taken. and if the measures differ by more&#xD;
      than 0.2 kg, a third measure will be taken. An average of the closest two measures will be&#xD;
      calculated and used for data entry.&#xD;
&#xD;
      Waist circumference. Waist circumference will be assessed at baseline, 3 and 6 months. Waist&#xD;
      circumference will be taken according to the National Health and Nutrition Examination survey&#xD;
      anthropometry procedures manual. Measurements will be taken to the nearest 0.1cm, at the top&#xD;
      of the pelvis ilium (just above the hip bone) with a non-stretchable tape measure, without&#xD;
      compressing the skin, at the end of normal expiration. Two measurements will be taken with a&#xD;
      third if the first two do not fall within 0.5 cm.&#xD;
&#xD;
      Aerobic stamina. Aerobic stamina will be assessed using the 6 minute walk test. Distance&#xD;
      traveled in meters (m) is the outcome.&#xD;
&#xD;
      Flexibility. Flexibility will be assessed with the Classic Sit and Reach Test and reported in&#xD;
      inches less than or greater than reached on a 20 inch reference mark as measured on a yard&#xD;
      stick placed between the legs.&#xD;
&#xD;
      Food Cravings. The Food Craving Inventory-II (FCI-II) is a validated self-report measure for&#xD;
      general cravings and cravings for specific types of foods and will be completed at baseline,&#xD;
      Months 3 and 6. Respondents rate the frequency of cravings since the last time they completed&#xD;
      the survey for each of 33 food items using a five-point Likert scale (1, never; 2, rarely; 3,&#xD;
      sometimes; 4, often; 5, always/almost every day). The FCI-II consists of 5 scales (sweets,&#xD;
      high fats, carbohydrates/starches, fast food fats, and fruits &amp; vegetables) that constitute&#xD;
      the higher order construct of food cravings (the total score).&#xD;
&#xD;
      Happiness. The Oxford Happiness Questionnaire will be used to assess happiness at 0, 3, and 6&#xD;
      months. The OHQ is a validated self-report measure for broad personal happiness. Respondents&#xD;
      rate 29 sentences on a 6 point Likert scale (1, strongly disagree; 6, strong agree).&#xD;
&#xD;
      Sleep. Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) to&#xD;
      assess sleep quality and duration at 0, 3, 6. The PSQI is a validated self-report measure of&#xD;
      sleep duration and sleep quality. The PSQI examines seven components of sleep quality&#xD;
      retrospectively over a period of four weeks: subjective sleep quality, sleep latency, sleep&#xD;
      duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and&#xD;
      daytime dysfunction over the last month. The patient self-rates each of these seven areas of&#xD;
      sleep. Scoring of answers is based on a 0-3 scale, whereby '3' reflects the negative extreme&#xD;
      on the Likert scale. The global score is generated by summing up all seven component scores&#xD;
      and ranges from 0 to 21, with higher values corresponding to reduced sleep quality.&#xD;
&#xD;
      Weight related quality of life. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is&#xD;
      a validated self-report measure for an individual's perception of how their weight affects&#xD;
      their day-to-day life. Respondents rate the degree to which their weight affects them on 31&#xD;
      items using a five-point Likert scale (1, never true; 2, rarely true; 3, sometimes true; 4,&#xD;
      usually true; 5, always true). The IWQOL-Lite consists of 5 scales (physical function,&#xD;
      self-esteem, sexual life, public distress, and work).&#xD;
&#xD;
      Perceived Hunger. The Visual Analogue Scale (VAS) measures sensations that range across a&#xD;
      continuum of values and cannot be easily directly measured. Operationally, the VAS is a&#xD;
      horizontal line measuring exactly 100 mm in length, anchored by word descriptors (i.e., Not&#xD;
      at all hungry, Extremely hungry) at each end. Participants will be asked to complete a three&#xD;
      item VAS by placing a mark on the line at the point they feel represents their response to&#xD;
      the question.&#xD;
&#xD;
      Program Satisfaction. The Satisfaction Survey is a self-administered survey with 25 items&#xD;
      scored on a 5-point Likert scale. This measure will be completed at only at 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Change</measure>
    <time_frame>0 - 6 months</time_frame>
    <description>Mean Change in body weight (kg) Body weight will be assessed on a calibrated digital scale and recorded to the nearest 0.1 kg.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Achieving a weight loss of 5% or more</measure>
    <time_frame>0 - 6 months</time_frame>
    <description>% participants achieving a weight loss of 5% initial body weight or more</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achieving a weight loss of 5% or more</measure>
    <time_frame>0 - 3 months</time_frame>
    <description>% participants achieving a weight loss of 5% initial body weight or more</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight Change</measure>
    <time_frame>0 - 3 months</time_frame>
    <description>Mean Change in body weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference change (cm) (mean)</measure>
    <time_frame>0 - 3 months</time_frame>
    <description>Waist circumference will be measured at the iliac crest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference change (cm) (mean)</measure>
    <time_frame>0 - 6 months</time_frame>
    <description>Waist circumference will be measured at the iliac crest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between fitness, flexibility and psychosocial measures with weight change</measure>
    <time_frame>0 - 6 months</time_frame>
    <description>The relationship between weight change and any of these measures will be assessed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">152</enrollment>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Modified Weight Watchers plan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Modified Weight Watchers Plan which includes a food plan, activity plan, group support and cognitive behavior modification. Weekly study-specific group meetings; electronic tools through iPhone app for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Modified Weight Watchers plan</intervention_name>
    <description>Weight Watchers is a structured lifestyle modification program that includes a food plan based on balanced diet and healthy eating, activity plan designed to promote progressive physical activity increase, group support and cognitive behavior modification. Participants attend weekly in-person group meetings led by a trained Weight Watchers meeting leader and have a suite of electronic tools available through an iPhone app.</description>
    <arm_group_label>Modified Weight Watchers plan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) between 25 and 43 kg/m²&#xD;
&#xD;
          -  Ability to read and speak English&#xD;
&#xD;
          -  All ethnic groups will be recruited&#xD;
&#xD;
          -  Self-report desire to lose weight and willing to follow study recommendations&#xD;
&#xD;
          -  Use of an iPhone with iOS 8.0 or later for use on a daily basis, and basic app skills&#xD;
&#xD;
          -  Have access to the internet via a computer, and basic computer skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently following a commercial weight-loss program (including Weight Watchers) or&#xD;
             who followed a weight loss program in the previous 6 months or who were members of&#xD;
             Weight Watchers within the past 12 months&#xD;
&#xD;
          -  Another member of the household participating in the study.&#xD;
&#xD;
          -  Pregnant or nursing, or planning on becoming pregnant over the next 9 months.&#xD;
&#xD;
          -  Planning to relocate in the next 9 months&#xD;
&#xD;
          -  Involvement in another research study that would interfere with participation in this&#xD;
             study&#xD;
&#xD;
          -  Excessive alcohol intake or dependence&#xD;
&#xD;
          -  Recent weight loss of ≥ 5 kg in the previous 6 months.&#xD;
&#xD;
          -  Report health problems that make weight loss or unsupervised exercise unsafe or&#xD;
             unreasonable (e.g., orthopedic limitations, heart problems, history or heart attack or&#xD;
             stroke)&#xD;
&#xD;
          -  History of clinically diagnosed eating disorder.&#xD;
&#xD;
          -  Untreated thyroid disease or and changes in dose or type of thyroid medication over&#xD;
             previous 6 months&#xD;
&#xD;
          -  Chronic/inflammatory gastrointestinal disorders (Irritable Bowel Syndrome acceptable)&#xD;
&#xD;
          -  Taking any prescription medication with known effects on appetite or weight&#xD;
&#xD;
          -  Previous surgical procedure for weight loss.&#xD;
&#xD;
          -  Major surgery within the previous 6 months.&#xD;
&#xD;
          -  Resting systolic blood pressure &gt;160 mmHg or resting diastolic blood pressure &gt;100&#xD;
             mmHg&#xD;
&#xD;
          -  Diuretic use over 1.5mg per day&#xD;
&#xD;
          -  Diagnosis of type 1 or type 2 diabetes&#xD;
&#xD;
          -  Presence of implanted cardiac defibrillator or pacemaker.&#xD;
&#xD;
          -  History of presence of cancer within past 5 years or current treatment for cancer&#xD;
             (completely resected basal or squamous cell carcinoma acceptable if treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah F Tate, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>May 17, 2018</last_update_submitted>
  <last_update_submitted_qc>May 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <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/NCT03037567
org study id: 16-3421
nct id: NCT03037567
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the acceptability and efficacy of a modified Weight
      Watchers program over 24 weeks. Assessments will be conducted at 0, 3, and 6 months.
The following assessment measures will be taken at 0, 3, and 6 months:

      Weight measurements. Weight will be taken according to the National Health and Nutrition
      Examination survey anthropometry procedures manual. Weight will be measured in kilograms to
      the nearest 0.1 kg using a calibrated digital scale (Tanita, Inc.) with participants in light
      clothing and no shoes. Two measurements will be taken. and if the measures differ by more
      than 0.2 kg, a third measure will be taken. An average of the closest two measures will be
      calculated and used for data entry.

      Waist circumference. Waist circumference will be assessed at baseline, 3 and 6 months. Waist
      circumference will be taken according to the National Health and Nutrition Examination survey
      anthropometry procedures manual. Measurements will be taken to the nearest 0.1cm, at the top
      of the pelvis ilium (just above the hip bone) with a non-stretchable tape measure, without
      compressing the skin, at the end of normal expiration. Two measurements will be taken with a
      third if the first two do not fall within 0.5 cm.

      Aerobic stamina. Aerobic stamina will be assessed using the 6 minute walk test. Distance
      traveled in meters (m) is the outcome.

      Flexibility. Flexibility will be assessed with the Classic Sit and Reach Test and reported in
      inches less than or greater than reached on a 20 inch reference mark as measured on a yard
      stick placed between the legs.

      Food Cravings. The Food Craving Inventory-II (FCI-II) is a validated self-report measure for
      general cravings and cravings for specific types of foods and will be completed at baseline,
      Months 3 and 6. Respondents rate the frequency of cravings since the last time they completed
      the survey for each of 33 food items using a five-point Likert scale (1, never; 2, rarely; 3,
      sometimes; 4, often; 5, always/almost every day). The FCI-II consists of 5 scales (sweets,
      high fats, carbohydrates/starches, fast food fats, and fruits & vegetables) that constitute
      the higher order construct of food cravings (the total score).

      Happiness. The Oxford Happiness Questionnaire will be used to assess happiness at 0, 3, and 6
      months. The OHQ is a validated self-report measure for broad personal happiness. Respondents
      rate 29 sentences on a 6 point Likert scale (1, strongly disagree; 6, strong agree).

      Sleep. Participants will be asked to complete the Pittsburgh Sleep Quality Index (PSQI) to
      assess sleep quality and duration at 0, 3, 6. The PSQI is a validated self-report measure of
      sleep duration and sleep quality. The PSQI examines seven components of sleep quality
      retrospectively over a period of four weeks: subjective sleep quality, sleep latency, sleep
      duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and
      daytime dysfunction over the last month. The patient self-rates each of these seven areas of
      sleep. Scoring of answers is based on a 0-3 scale, whereby '3' reflects the negative extreme
      on the Likert scale. The global score is generated by summing up all seven component scores
      and ranges from 0 to 21, with higher values corresponding to reduced sleep quality.

      Weight related quality of life. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) is
      a validated self-report measure for an individual's perception of how their weight affects
      their day-to-day life. Respondents rate the degree to which their weight affects them on 31
      items using a five-point Likert scale (1, never true; 2, rarely true; 3, sometimes true; 4,
      usually true; 5, always true). The IWQOL-Lite consists of 5 scales (physical function,
      self-esteem, sexual life, public distress, and work).

      Perceived Hunger. The Visual Analogue Scale (VAS) measures sensations that range across a
      continuum of values and cannot be easily directly measured. Operationally, the VAS is a
      horizontal line measuring exactly 100 mm in length, anchored by word descriptors (i.e., Not
      at all hungry, Extremely hungry) at each end. Participants will be asked to complete a three
      item VAS by placing a mark on the line at the point they feel represents their response to
      the question.

      Program Satisfaction. The Satisfaction Survey is a self-administered survey with 25 items
      scored on a 5-point Likert scale. This measure will be completed at only at 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight Change
time frame: 0 - 6 months
description: Mean Change in body weight (kg) Body weight will be assessed on a calibrated digital scale and recorded to the nearest 0.1 kg.
measure: Achieving a weight loss of 5% or more
time frame: 0 - 6 months
description: % participants achieving a weight loss of 5% initial body weight or more
measure: Achieving a weight loss of 5% or more
time frame: 0 - 3 months
description: % participants achieving a weight loss of 5% initial body weight or more
measure: Weight Change
time frame: 0 - 3 months
description: Mean Change in body weight (kg)
measure: Waist circumference change (cm) (mean)
time frame: 0 - 3 months
description: Waist circumference will be measured at the iliac crest
measure: Waist circumference change (cm) (mean)
time frame: 0 - 6 months
description: Waist circumference will be measured at the iliac crest
measure: Relationship between fitness, flexibility and psychosocial measures with weight change
time frame: 0 - 6 months
description: The relationship between weight change and any of these measures will be assessed.
arm group label: Modified Weight Watchers plan
arm group type: Experimental
description: Modified Weight Watchers Plan which includes a food plan, activity plan, group support and cognitive behavior modification. Weekly study-specific group meetings; electronic tools through iPhone app for 24 weeks.
intervention type: Behavioral
intervention name: Modified Weight Watchers plan
description: Weight Watchers is a structured lifestyle modification program that includes a food plan based on balanced diet and healthy eating, activity plan designed to promote progressive physical activity increase, group support and cognitive behavior modification. Participants attend weekly in-person group meetings led by a trained Weight Watchers meeting leader and have a suite of electronic tools available through an iPhone app.
arm group label: Modified Weight Watchers plan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Deborah F Tate, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight
mesh term: Weight Loss
sharing ipd: No