<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/NCT03014414</url>
  </required_header>
  <id_info>
    <org_study_id>37586</org_study_id>
    <secondary_id>R01HL128666</secondary_id>
    <nct_id>NCT03014414</nct_id>
  </id_info>
  <brief_title>Stanford Healthy Heart Study</brief_title>
  <official_title>Escalating Proportion of Weight-Loss Maintainers Via Modules Prior to Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      People with elevated blood pressure are at higher risk of having a heart attack or stroke&#xD;
      than people with lower blood pressure. Losing a modest amount of weight-such as 15 or 20&#xD;
      pounds-can reduce the risk of having a heart attack or stroke. However, it can often be a&#xD;
      struggle to maintain weight loss over time.&#xD;
&#xD;
      This study examines whether two behavioral weight-management programs can help people&#xD;
      maintain weight loss over time. In this study, 346 adults will be randomly assigned (like&#xD;
      flipping a coin) to one of the 12-month programs and followed for 36 months (i.e., 3 years)&#xD;
      to see how their body weight may change.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized trial will test the efficacy and cost-effectiveness of novel modules&#xD;
      administered prior to weight loss that are explicitly designed to enhance enjoyment of&#xD;
      healthy lifestyle behaviors independent of any longer-term health effects, and thus escalate&#xD;
      the proportion of individuals sustaining ≥7% weight loss over the long-term.&#xD;
&#xD;
      Overweight/obese individuals with elevated blood pressure will be randomized to one of two&#xD;
      12-month weight-management interventions (Fun First or Weight Watchers) and followed for 36&#xD;
      months. For Aim 1 (Primary outcome), we will test whether Fun First is more efficacious than&#xD;
      Weight Watchers using a mediator-intervention interaction model with sufficient a priori&#xD;
      statistical power for the interaction effect as well as the intervention and mediator main&#xD;
      effects. The posited mediator assesses participants' change in enjoyment for four key healthy&#xD;
      lifestyle behaviors (healthy eating, physical activity, weighing and self-nurturing) via&#xD;
      online survey from 0-2 months. The primary outcome is the proportion of participants who lose&#xD;
      a clinically significant amount of initial body weight and maintain it during the trial&#xD;
      (i.e., lose &gt;=7% of their initial body weight from 0-12 months and gain &lt;=5 lbs from 12-36&#xD;
      months), assessed on clinic scales during in-person visits at the research clinic. Secondary&#xD;
      outcomes include the proportion of individuals sustaining ≥7% weight loss over the trial&#xD;
      assessed by digital cellular scales in participants' homes and participants' change in&#xD;
      systolic blood pressure over the trial assessed at the research clinic.&#xD;
&#xD;
      For Aim 2 (Other pre-specified outcomes), we will test whether Fun First is more cost&#xD;
      effective than Weight Watchers using both individual-level trial data and systems science&#xD;
      modeling for long-term, population-level hypertension and cardiovascular disease incidence,&#xD;
      health care and disability costs, and quality-adjusted life-years over the life course.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2017</start_date>
  <completion_date type="Actual">January 27, 2022</completion_date>
  <primary_completion_date type="Actual">January 27, 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants who lose a clinically significant amount of initial body weight AND maintain it during the trial (i.e., Lose &gt;=7% of their initial body weight from 0-12 months AND gain &lt;=5 lbs from 12-36 months), assessed by clinic scales</measure>
    <time_frame>Baseline to 36 months</time_frame>
    <description>Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of participants who lose a clinically significant amount of initial body weight AND maintain it during the trial (Lose &gt;=7% of their initial body weight from 0-12 months AND gain &lt;=5 lbs from 12-36 months), assessed by cellular scales</measure>
    <time_frame>Baseline to 36 months</time_frame>
    <description>Participants will be asked to weigh themselves at home on study-provided digital scales at least every 3 months from 0 to 36 months. Scales transmit body weight data via cellular technology in real time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systolic blood pressure from 0-36 months</measure>
    <time_frame>Baseline to 36 months</time_frame>
    <description>Participants will have their systolic blood pressure assessed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in self-reported enjoyment of healthy lifestyle behaviors from 0-2 months</measure>
    <time_frame>Baseline to 2 months</time_frame>
    <description>Participants will rate their enjoyment of four key healthy lifestyle behaviors (healthy eating, physical activity, weighing, self-nurturing) via online survey at 0, 2, 6, 12, 24, and 36 months [Change in enjoyment from 0-2 months is the mediator in the efficacy model]</description>
  </other_outcome>
  <other_outcome>
    <measure>Incremental cost-effectiveness ratio (U.S. Dollars per quality-adjusted life-years) of either weight-management intervention versus no intervention</measure>
    <time_frame>Baseline to 36 months</time_frame>
    <description>Participants will self-report their work productivity, costs, and quality-of-life via online surveys [Ratio will be based on changes in productivity, costs, and quality-adjusted life-years over the life course in the simulated cost-effectiveness model, see below for three self-reported measures incorporated into model]</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in self-reported work productivity and activity from 6-36 months</measure>
    <time_frame>6 to 36 months</time_frame>
    <description>Participants will report their work productivity and activity using the Work Productivity and Activity Impairment Questionnaire via online survey at 6, 12, 24, and 36 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in self-reported costs of participating in the weight-management interventions from 6-36 months</measure>
    <time_frame>6 to 36 months</time_frame>
    <description>Participants will rate their costs of participating in the weight-management interventions via online survey at 6, 12, 24, and 36 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in self-reported quality of life from 0-36 months</measure>
    <time_frame>Baseline to 36 months</time_frame>
    <description>Participants will rate their quality of life using the Short Form Health Survey (SF-36) via online survey at 0, 6, 12, 24, and 36 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in weight in kilograms from 0-36 months, assessed by clinic scales</measure>
    <time_frame>Baseline to 36 months</time_frame>
    <description>Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of participants who lose &gt;=5% of their initial body weight from 0-36 months, assessed by clinic scales</measure>
    <time_frame>Baseline to 36 months</time_frame>
    <description>Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in weight in kilograms from 0-36 months, assessed by cellular scales</measure>
    <time_frame>Baseline to 36 months</time_frame>
    <description>Participants will be asked to weigh themselves at home on study-provided digital scales at least every 3 months from 0 to 36 months. Scales transmit body weight data via cellular technology in real time</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of participants who lose &gt;=5% of their initial body weight from 0-36 months, assessed by cellular scales</measure>
    <time_frame>Baseline to 36 months</time_frame>
    <description>Participants will be asked to weigh themselves at home on study-provided digital scales at least every 3 months from 0 to 36 months. Scales transmit body weight data via cellular technology in real time</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">321</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Fun First</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If randomized to the 12-month Fun First program, participants will attend weekly interactive small-group sessions led by health coaches for 6 months, then receive monthly phone calls from coaches for 6 months. The first 6 months consists of a 2-month module promoting enjoyment of key maintenance skills before losing weight, followed by a 4-month behavioral weight-loss program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight Watchers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>If randomized to the 12-month Weight Watchers program, participants are provided with study-paid access to weekly ongoing Weight Watchers meetings led by peer meeting leaders for 12 months at Weight Watchers locations convenient to participants as well as study-paid access to Weight Watchers personalized online tools. [The study and investigative team have no financial relationship with Weight Watchers].</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fun First</intervention_name>
    <description>Learn key enjoyable maintenance skills before losing weight</description>
    <arm_group_label>Fun First</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight Watchers</intervention_name>
    <description>Focus on losing weight first via convenient meetings and personalized online tools</description>
    <arm_group_label>Weight Watchers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (BMI):&#xD;
&#xD;
          -  27 &lt;= BMI &lt; 45 kg/m2&#xD;
&#xD;
        Inclusion Criteria (Elevated Blood Pressure):&#xD;
&#xD;
          -  Systolic blood pressure between 120-159 mmHg OR diastolic blood pressure between 80-99&#xD;
             mmHg. Can be on &gt;=1 antihypertensive medications if on stable dose for past 3 months&#xD;
&#xD;
          -  Systolic blood pressure &lt;120 mmHg OR diastolic blood pressure &lt;80 mmHg, if on stable&#xD;
             dose of &gt;=1 antihypertensive medications for past 3 months&#xD;
&#xD;
        Exclusion Criteria (Blood Pressure):&#xD;
&#xD;
          -  Elevated blood pressure: Systolic blood pressure &gt;=160 mmHg OR diastolic blood&#xD;
             pressure &gt;=100 mmHg&#xD;
&#xD;
        Exclusion Criteria (Underlying medical conditions/diseases):&#xD;
&#xD;
          -  Have had a heart attack, stroke, coronary heart disease, congestive heart failure, or&#xD;
             angina&#xD;
&#xD;
          -  Have had coronary artery bypass surgery or cardiac catheterization such as&#xD;
             percutaneous transluminal coronary angioplasty (PTCA), cath or stent placement&#xD;
&#xD;
          -  Have diabetes&#xD;
&#xD;
          -  Have medical contraindications to regular, unsupervised physical activity&#xD;
&#xD;
          -  Have moderate to severe asthma, or chronic obstructive pulmonary disorder (also called&#xD;
             emphysema or chronic bronchitis)&#xD;
&#xD;
          -  Had cancer in the past 5 years (except non-melanoma skin cancer)&#xD;
&#xD;
          -  Currently under medical care for digestive issues, gastrointestinal distress,&#xD;
             abdominal pain, or diarrhea&#xD;
&#xD;
          -  Had an organ transplant&#xD;
&#xD;
        Exclusion Criteria (Medications):&#xD;
&#xD;
          -  Not stable on medications over the past 3 months (e.g., cholesterol, thyroid,&#xD;
             estrogen-hormone, psychiatric)&#xD;
&#xD;
          -  Currently taking prescription pain medications (e.g., Vicodin, Oxycodone)&#xD;
&#xD;
        Exclusion Criteria (Weight and diet related):&#xD;
&#xD;
          -  Have binge eating disorder or bulimic compensatory symptoms&#xD;
&#xD;
          -  Currently taking medication designed to lose weight&#xD;
&#xD;
          -  Have undergone weight-loss surgery (e.g., gastric bypass, lap band)&#xD;
&#xD;
          -  Have lost &gt;10 pounds in the past 6 months&#xD;
&#xD;
          -  Currently in a weight-loss program (e.g., Jenny Craig)&#xD;
&#xD;
          -  Currently participating in any support groups that focus on weight or eating habits&#xD;
             (e.g., Overeaters Anonymous)&#xD;
&#xD;
          -  Currently on a special diet for a serious health condition&#xD;
&#xD;
          -  Not willing to discontinue a special diet (e.g., Atkins)&#xD;
&#xD;
        Exclusion Criteria (Behavioral related):&#xD;
&#xD;
          -  Planning to move in the next year&#xD;
&#xD;
          -  Currently pregnant or planning to be within the next year&#xD;
&#xD;
          -  Participating in another research study&#xD;
&#xD;
          -  No regular access to a mobile phone and Internet&#xD;
&#xD;
          -  Not able to speak, read, or understand English for informed consent&#xD;
&#xD;
          -  Not willing to be randomized&#xD;
&#xD;
          -  Did not complete eligibility process successfully or in a timely manner&#xD;
&#xD;
          -  Staff discretion or judgement&#xD;
&#xD;
          -  Live within Bay Area (e.g., ~1-hour commute from Stanford research center)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michaela Kiernan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 2, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Michaela Kiernan</investigator_full_name>
    <investigator_title>Senior Research Scholar</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After final quality control and statistical analyses are completed, final project data will be made available to individuals who submit a written data request to the Principal Investigator. This centralized data request process provides a tracking mechanism to inform other external groups about similar analysis activities.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03014414/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03014414
org study id: 37586
secondary id: R01HL128666
nct id: NCT03014414
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
People with elevated blood pressure are at higher risk of having a heart attack or stroke
      than people with lower blood pressure. Losing a modest amount of weight-such as 15 or 20
      pounds-can reduce the risk of having a heart attack or stroke. However, it can often be a
      struggle to maintain weight loss over time.

      This study examines whether two behavioral weight-management programs can help people
      maintain weight loss over time. In this study, 346 adults will be randomly assigned (like
      flipping a coin) to one of the 12-month programs and followed for 36 months (i.e., 3 years)
      to see how their body weight may change.
This randomized trial will test the efficacy and cost-effectiveness of novel modules
      administered prior to weight loss that are explicitly designed to enhance enjoyment of
      healthy lifestyle behaviors independent of any longer-term health effects, and thus escalate
      the proportion of individuals sustaining ≥7% weight loss over the long-term.

      Overweight/obese individuals with elevated blood pressure will be randomized to one of two
      12-month weight-management interventions (Fun First or Weight Watchers) and followed for 36
      months. For Aim 1 (Primary outcome), we will test whether Fun First is more efficacious than
      Weight Watchers using a mediator-intervention interaction model with sufficient a priori
      statistical power for the interaction effect as well as the intervention and mediator main
      effects. The posited mediator assesses participants' change in enjoyment for four key healthy
      lifestyle behaviors (healthy eating, physical activity, weighing and self-nurturing) via
      online survey from 0-2 months. The primary outcome is the proportion of participants who lose
      a clinically significant amount of initial body weight and maintain it during the trial
      (i.e., lose >=7% of their initial body weight from 0-12 months and gain <=5 lbs from 12-36
      months), assessed on clinic scales during in-person visits at the research clinic. Secondary
      outcomes include the proportion of individuals sustaining ≥7% weight loss over the trial
      assessed by digital cellular scales in participants' homes and participants' change in
      systolic blood pressure over the trial assessed at the research clinic.

      For Aim 2 (Other pre-specified outcomes), we will test whether Fun First is more cost
      effective than Weight Watchers using both individual-level trial data and systems science
      modeling for long-term, population-level hypertension and cardiovascular disease incidence,
      health care and disability costs, and quality-adjusted life-years over the life course.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Proportion of participants who lose a clinically significant amount of initial body weight AND maintain it during the trial (i.e., Lose >=7% of their initial body weight from 0-12 months AND gain <=5 lbs from 12-36 months), assessed by clinic scales
time frame: Baseline to 36 months
description: Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months
measure: Proportion of participants who lose a clinically significant amount of initial body weight AND maintain it during the trial (Lose >=7% of their initial body weight from 0-12 months AND gain <=5 lbs from 12-36 months), assessed by cellular scales
time frame: Baseline to 36 months
description: Participants will be asked to weigh themselves at home on study-provided digital scales at least every 3 months from 0 to 36 months. Scales transmit body weight data via cellular technology in real time
measure: Change in systolic blood pressure from 0-36 months
time frame: Baseline to 36 months
description: Participants will have their systolic blood pressure assessed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months
measure: Change in self-reported enjoyment of healthy lifestyle behaviors from 0-2 months
time frame: Baseline to 2 months
description: Participants will rate their enjoyment of four key healthy lifestyle behaviors (healthy eating, physical activity, weighing, self-nurturing) via online survey at 0, 2, 6, 12, 24, and 36 months [Change in enjoyment from 0-2 months is the mediator in the efficacy model]
measure: Incremental cost-effectiveness ratio (U.S. Dollars per quality-adjusted life-years) of either weight-management intervention versus no intervention
time frame: Baseline to 36 months
description: Participants will self-report their work productivity, costs, and quality-of-life via online surveys [Ratio will be based on changes in productivity, costs, and quality-adjusted life-years over the life course in the simulated cost-effectiveness model, see below for three self-reported measures incorporated into model]
measure: Change in self-reported work productivity and activity from 6-36 months
time frame: 6 to 36 months
description: Participants will report their work productivity and activity using the Work Productivity and Activity Impairment Questionnaire via online survey at 6, 12, 24, and 36 months
measure: Change in self-reported costs of participating in the weight-management interventions from 6-36 months
time frame: 6 to 36 months
description: Participants will rate their costs of participating in the weight-management interventions via online survey at 6, 12, 24, and 36 months
measure: Change in self-reported quality of life from 0-36 months
time frame: Baseline to 36 months
description: Participants will rate their quality of life using the Short Form Health Survey (SF-36) via online survey at 0, 6, 12, 24, and 36 months
measure: Change in weight in kilograms from 0-36 months, assessed by clinic scales
time frame: Baseline to 36 months
description: Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months
measure: Proportion of participants who lose >=5% of their initial body weight from 0-36 months, assessed by clinic scales
time frame: Baseline to 36 months
description: Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months
measure: Change in weight in kilograms from 0-36 months, assessed by cellular scales
time frame: Baseline to 36 months
description: Participants will be asked to weigh themselves at home on study-provided digital scales at least every 3 months from 0 to 36 months. Scales transmit body weight data via cellular technology in real time
measure: Proportion of participants who lose >=5% of their initial body weight from 0-36 months, assessed by cellular scales
time frame: Baseline to 36 months
description: Participants will be asked to weigh themselves at home on study-provided digital scales at least every 3 months from 0 to 36 months. Scales transmit body weight data via cellular technology in real time
arm group label: Fun First
arm group type: Experimental
description: If randomized to the 12-month Fun First program, participants will attend weekly interactive small-group sessions led by health coaches for 6 months, then receive monthly phone calls from coaches for 6 months. The first 6 months consists of a 2-month module promoting enjoyment of key maintenance skills before losing weight, followed by a 4-month behavioral weight-loss program.
arm group label: Weight Watchers
arm group type: Active Comparator
description: If randomized to the 12-month Weight Watchers program, participants are provided with study-paid access to weekly ongoing Weight Watchers meetings led by peer meeting leaders for 12 months at Weight Watchers locations convenient to participants as well as study-paid access to Weight Watchers personalized online tools. [The study and investigative team have no financial relationship with Weight Watchers].
intervention type: Behavioral
intervention name: Fun First
description: Learn key enjoyable maintenance skills before losing weight
arm group label: Fun First
intervention type: Behavioral
intervention name: Weight Watchers
description: Focus on losing weight first via convenient meetings and personalized online tools
arm group label: Weight Watchers
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Michaela Kiernan, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Michaela Kiernan
investigator title: Senior Research Scholar
sharing ipd: Yes
ipd description: After final quality control and statistical analyses are completed, final project data will be made available to individuals who submit a written data request to the Principal Investigator. This centralized data request process provides a tracking mechanism to inform other external groups about similar analysis activities.
provided document: 