<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/NCT03032731</url>
  </required_header>
  <id_info>
    <org_study_id>EP 16/17 034</org_study_id>
    <nct_id>NCT03032731</nct_id>
  </id_info>
  <brief_title>Trial of a New Online Programme for Physical Activity and Healthy Eating.</brief_title>
  <official_title>Trial of a Self-directed Behaviour Change Intervention for Physical Activity and Healthy Eating.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bath</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bath</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>
      Many healthy lifestyle interventions have been developed to help people change their activity&#xD;
      and diet, lose weight and thus reduce their risk of developing type 2 diabetes (T2DM) and&#xD;
      cardiovascular disorders (CVD). However, these interventions often fail to engage their&#xD;
      target audience, which undermines their effectiveness in changing behaviour and health&#xD;
      outcomes.&#xD;
&#xD;
      The purpose of this study is to investigate the effectiveness of a self-directed,&#xD;
      website-based intervention to promote physical activity and healthy dietary behaviours. The&#xD;
      intervention frames health information from a novel perspective, which our previous work has&#xD;
      indicated can help to promote interest in the health information and improve attitudes,&#xD;
      self-efficacy and motivation towards physical activity and healthy dietary behaviours.&#xD;
&#xD;
      The intervention comprises a website of information resources and personal recording areas to&#xD;
      set goals and monitor activity and diet, weekly emails and pedometers. In this trial we aim&#xD;
      to see whether the intervention has any impact on people's physical activity and diet, as&#xD;
      well as their risk of developing CVD and T2DM. The intervention will be compared with a&#xD;
      control condition in which participants will be shown standard resources available on NHS&#xD;
      websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be&#xD;
      recruited from the community. The active intervention will last 6 weeks (during this period&#xD;
      participants will receive weekly emails from the research team) and there will be a 6-week&#xD;
      follow-up phase (in which participants will still have access to the website but contact from&#xD;
      the research team). Activity, diet, disease risk markers and psychological antecedents of&#xD;
      behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12-&#xD;
      weeks).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2017</start_date>
  <completion_date type="Actual">September 12, 2017</completion_date>
  <primary_completion_date type="Actual">September 12, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean daily physical activity level (PAL)</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Mean daily physical activity level (PAL) will be assessed using accelerometers (BodyMedia, worn on the upper arm), worn for a continuous 7-day period, being removed during this time only for water-based activities such as showering or swimming. The accelerometers gather minute by minute total energy expenditure (TEE) data, which will be used to calculate PAL (PAL = TEE/BMR, where BMR = basal metabolic rate, to be calculated using the Schofield equation).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in mean daily energy intake (EI)</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Mean daily energy intake (EI) will be assessed using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting plasma glucose concentration</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of glucose concentration in the blood plasma at rest across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting plasma insulin concentration</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of insulin concentration in the blood plasma at rest across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting triglyceride concentration</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of triglyceride concentration in the blood serum at rest across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting total cholesterol concentration</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of total concentration in the blood serum at rest across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting LDL cholesterol concentration</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of LDL concentration in the blood serum at rest across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting HDL cholesterol concentration</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of HDL concentration in the blood serum at rest across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein (CRP) concentration</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of CRP concentration in the blood serum at rest across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI)</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of BMI (defined as mass in kg divided by height in metres squared) across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of waist circumference (in centimetres) across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Comparison of blood pressure (systolic/diastolic mmHG) across all three measurement points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of diet</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Diet quality will be assessed based on the proportion of fibre, free sugars and refined carbohydrates, and saturated fats in the diet. The intervention aims to promote an increase in fibre intake and decrease in free sugar, refined carbohydrate and saturated fat intake. Data will be collected using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation for physical activity</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Motivation will be assessed using the Behavioural Regulation for Exercise Questionnaire 3 (BREQ 3: Markland &amp; Tobin, 2004; Wilson, Rodgers, Loitz &amp; Scime, 2006) adapted for physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motivation for healthy eating</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Motivation will be assessed using the Behavioural Regulation for Exercise Questionnaire 3 (BREQ 3: Markland &amp; Tobin, 2004; Wilson, Rodgers, Loitz &amp; Scime, 2006) adapted for diet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for physical activity and healthy eating</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Self-efficacy will be measured using the Barriers Self-Efficacy Scale for Exercise (BARSE; McAuley, 1992) adapted for physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for healthy eating</measure>
    <time_frame>Baseline, 6 weeks and 12 weeks after starting the intervention/control period</time_frame>
    <description>Self-efficacy will be measured using the self-efficacy scale for eating a healthy diet developed by Pawlak and Colby (2009).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Overweight/Obesity</condition>
  <arm_group>
    <arm_group_label>Website and pedometer Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants allocated to this group will be given a one-off set-up session in which a researcher will show them the intervention website, create a user profile for them and provide guidance on how to use the site to gain health information, set personal behavioural goals and record and monitor their behaviour in relation to their goals. The researcher will also provide the participant with a pedometer and instruct them how to use this and where they can record their daily steps on the website. For 6 weeks, participants will be asked to use the website and be sent weekly email reminders to do so and log their goal progress. After 6 weeks, no further emails will be sent but participants will still be able to access the website and use the pedometer if they wish.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants allocated to this group will be given a one-off session in which a researcher shows them publicly available web-based resources for health behaviour change (provided by the National Health Service (NHS)). Like those participants in the intervention group, they will be assessed again after 6 and 12 weeks. Participants in the control arm will be offered the intervention (access to the study website and a pedometer) after 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Website and pedometer intervention</intervention_name>
    <description>Self-directed, website-based intervention delivered with a pedometer to promote understanding of health and health behaviour change.</description>
    <arm_group_label>Website and pedometer Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Standard, publicly available NHS resources for healthy lifestyles.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to give informed consent to participate in the study.&#xD;
&#xD;
          -  Male or female and aged between 35-74 years.&#xD;
&#xD;
          -  Defined as overweight or obese, i.e. BMI&gt;25kg/m2.&#xD;
&#xD;
          -  Able to travel to the university for assessment days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who are not fluent in the English language, and who do not have access to&#xD;
             and do not regularly use the internet and an email account.&#xD;
&#xD;
          -  Individuals diagnosed with coronary heart disease, chronic kidney disease, type 2&#xD;
             diabetes, stroke, heart failure, severe hypertension (BP&gt;180/110mmHg) and peripheral&#xD;
             arterial disease.&#xD;
&#xD;
          -  BMI&gt;40kg/m2 (morbidly obese).&#xD;
&#xD;
          -  Currently using weight loss drugs or other medication that can affect weight.&#xD;
&#xD;
          -  Any reported recent (i.e. last 6 months) shift (&gt;5%) in body mass or large change in&#xD;
             habitual lifestyle.&#xD;
&#xD;
          -  Individuals unable to change their physical activity (e.g. through disability).&#xD;
&#xD;
          -  Current (pre-baseline) or recent (i.e. last 2 months) participation in another&#xD;
             research trial or lifestyle supportive intervention or referral.&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dylan Thompson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bath</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Bath</name>
      <address>
        <city>Bath</city>
        <zip>BA2 7AY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>March 15, 2019</last_update_submitted>
  <last_update_submitted_qc>March 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Bath</investigator_affiliation>
    <investigator_full_name>Elisabeth Grey</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Diet</keyword>
  <keyword>Health Behavior</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</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/NCT03032731
org study id: EP 16/17 034
nct id: NCT03032731
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Many healthy lifestyle interventions have been developed to help people change their activity
      and diet, lose weight and thus reduce their risk of developing type 2 diabetes (T2DM) and
      cardiovascular disorders (CVD). However, these interventions often fail to engage their
      target audience, which undermines their effectiveness in changing behaviour and health
      outcomes.

      The purpose of this study is to investigate the effectiveness of a self-directed,
      website-based intervention to promote physical activity and healthy dietary behaviours. The
      intervention frames health information from a novel perspective, which our previous work has
      indicated can help to promote interest in the health information and improve attitudes,
      self-efficacy and motivation towards physical activity and healthy dietary behaviours.

      The intervention comprises a website of information resources and personal recording areas to
      set goals and monitor activity and diet, weekly emails and pedometers. In this trial we aim
      to see whether the intervention has any impact on people's physical activity and diet, as
      well as their risk of developing CVD and T2DM. The intervention will be compared with a
      control condition in which participants will be shown standard resources available on NHS
      websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be
      recruited from the community. The active intervention will last 6 weeks (during this period
      participants will receive weekly emails from the research team) and there will be a 6-week
      follow-up phase (in which participants will still have access to the website but contact from
      the research team). Activity, diet, disease risk markers and psychological antecedents of
      behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12-
      weeks).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
masking description: Open label
measure: Change in mean daily physical activity level (PAL)
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Mean daily physical activity level (PAL) will be assessed using accelerometers (BodyMedia, worn on the upper arm), worn for a continuous 7-day period, being removed during this time only for water-based activities such as showering or swimming. The accelerometers gather minute by minute total energy expenditure (TEE) data, which will be used to calculate PAL (PAL = TEE/BMR, where BMR = basal metabolic rate, to be calculated using the Schofield equation).
measure: Change in mean daily energy intake (EI)
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Mean daily energy intake (EI) will be assessed using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day .
measure: Fasting plasma glucose concentration
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of glucose concentration in the blood plasma at rest across all three measurement points.
measure: Fasting plasma insulin concentration
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of insulin concentration in the blood plasma at rest across all three measurement points.
measure: Fasting triglyceride concentration
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of triglyceride concentration in the blood serum at rest across all three measurement points.
measure: Fasting total cholesterol concentration
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of total concentration in the blood serum at rest across all three measurement points.
measure: Fasting LDL cholesterol concentration
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of LDL concentration in the blood serum at rest across all three measurement points.
measure: Fasting HDL cholesterol concentration
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of HDL concentration in the blood serum at rest across all three measurement points.
measure: C-reactive protein (CRP) concentration
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of CRP concentration in the blood serum at rest across all three measurement points.
measure: Body mass index (BMI)
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of BMI (defined as mass in kg divided by height in metres squared) across all three measurement points.
measure: Waist circumference
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of waist circumference (in centimetres) across all three measurement points.
measure: Blood pressure
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Comparison of blood pressure (systolic/diastolic mmHG) across all three measurement points.
measure: Quality of diet
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Diet quality will be assessed based on the proportion of fibre, free sugars and refined carbohydrates, and saturated fats in the diet. The intervention aims to promote an increase in fibre intake and decrease in free sugar, refined carbohydrate and saturated fat intake. Data will be collected using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day.
measure: Motivation for physical activity
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Motivation will be assessed using the Behavioural Regulation for Exercise Questionnaire 3 (BREQ 3: Markland & Tobin, 2004; Wilson, Rodgers, Loitz & Scime, 2006) adapted for physical activity.
measure: Motivation for healthy eating
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Motivation will be assessed using the Behavioural Regulation for Exercise Questionnaire 3 (BREQ 3: Markland & Tobin, 2004; Wilson, Rodgers, Loitz & Scime, 2006) adapted for diet.
measure: Self-efficacy for physical activity and healthy eating
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Self-efficacy will be measured using the Barriers Self-Efficacy Scale for Exercise (BARSE; McAuley, 1992) adapted for physical activity.
measure: Self-efficacy for healthy eating
time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
description: Self-efficacy will be measured using the self-efficacy scale for eating a healthy diet developed by Pawlak and Colby (2009).
arm group label: Website and pedometer Intervention
arm group type: Experimental
description: Participants allocated to this group will be given a one-off set-up session in which a researcher will show them the intervention website, create a user profile for them and provide guidance on how to use the site to gain health information, set personal behavioural goals and record and monitor their behaviour in relation to their goals. The researcher will also provide the participant with a pedometer and instruct them how to use this and where they can record their daily steps on the website. For 6 weeks, participants will be asked to use the website and be sent weekly email reminders to do so and log their goal progress. After 6 weeks, no further emails will be sent but participants will still be able to access the website and use the pedometer if they wish.
arm group label: Control
arm group type: Other
description: Participants allocated to this group will be given a one-off session in which a researcher shows them publicly available web-based resources for health behaviour change (provided by the National Health Service (NHS)). Like those participants in the intervention group, they will be assessed again after 6 and 12 weeks. Participants in the control arm will be offered the intervention (access to the study website and a pedometer) after 12 weeks.
intervention type: Behavioral
intervention name: Website and pedometer intervention
description: Self-directed, website-based intervention delivered with a pedometer to promote understanding of health and health behaviour change.
arm group label: Website and pedometer Intervention
intervention type: Other
intervention name: Control
description: Standard, publicly available NHS resources for healthy lifestyles.
arm group label: Control
criteria: 
gender: All
minimum age: 35 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dylan Thompson, PhD
role: Principal Investigator
affiliation: University of Bath
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Bath
investigator full name: Elisabeth Grey
investigator title: Principal investigator
mesh term: Overweight
sharing ipd: No