ObesityNCT03014414
Stanford Healthy Heart Study
A study testing Fun First and Weight Watchers in people with Obesity, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Fun First and Weight Watchers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2017to 27 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 27 <= BMI < 45 kg/m2
- Systolic blood pressure between 120-159 mmHg OR diastolic blood pressure between 80-99 mmHg. Can be on >=1 antihypertensive medications if on stable dose for past 3 months
- Systolic blood pressure <120 mmHg OR diastolic blood pressure <80 mmHg, if on stable dose of >=1 antihypertensive medications for past 3 months
Who cannot join
- Elevated blood pressure: Systolic blood pressure >=160 mmHg OR diastolic blood pressure >=100 mmHg
- Exclusion Criteria (Underlying medical conditions/diseases):
- Have had a heart attack, stroke, coronary heart disease, congestive heart failure, or angina
- Have had coronary artery bypass surgery or cardiac catheterization such as percutaneous transluminal coronary angioplasty (PTCA), cath or stent placement
- Have diabetes
- Have medical contraindications to regular, unsupervised physical activity
Show all 29Show fewer
- Have moderate to severe asthma, or chronic obstructive pulmonary disorder (also called emphysema or chronic bronchitis)
- Had cancer in the past 5 years (except non-melanoma skin cancer)
- Currently under medical care for digestive issues, gastrointestinal distress, abdominal pain, or diarrhea
- Had an organ transplant
- Not stable on medications over the past 3 months (e.g., cholesterol, thyroid, estrogen-hormone, psychiatric)
- Currently taking prescription pain medications (e.g., Vicodin, Oxycodone)
- Have binge eating disorder or bulimic compensatory symptoms
- Currently taking medication designed to lose weight
- Have undergone weight-loss surgery (e.g., gastric bypass, lap band)
- Have lost >10 pounds in the past 6 months
- Currently in a weight-loss program (e.g., Jenny Craig)
- Currently participating in any support groups that focus on weight or eating habits (e.g., Overeaters Anonymous)
- Currently on a special diet for a serious health condition
- Not willing to discontinue a special diet (e.g., Atkins)
- Planning to move in the next year
- Currently pregnant or planning to be within the next year
- Participating in another research study
- No regular access to a mobile phone and Internet
- Not able to speak, read, or understand English for informed consent
- Not willing to be randomized
- Did not complete eligibility process successfully or in a timely manner
- Staff discretion or judgement
- Live within Bay Area (e.g., ~1-hour commute from Stanford research center)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
Official title: Escalating Proportion of Weight-Loss Maintainers Via Modules Prior to Weight Loss
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.
Read the detailed description
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.
- Conditions
- Obesity
- Being tested
- Fun First, Weight Watchers
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fun FirstBehavioural
Learn key enjoyable maintenance skills before losing weight
Weight WatchersBehavioural
Focus on losing weight first via convenient meetings and personalized online tools
| Study group | Role | What they receive |
|---|---|---|
| Fun First | Experimental | 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. Receives: Behavioral: Fun First |
| Weight Watchers | Active comparator | 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]. Receives: Behavioral: Weight Watchers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months
Measured: Baseline to 36 months
Secondary outcomes (2)
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
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
Measured: Baseline to 36 months
Change in systolic blood pressure from 0-36 months
Participants will have their systolic blood pressure assessed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start4 Mar 2017
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michaela Kiernan, Stanford University
- Investigators
- Michaela Kiernan, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014414
- Sponsor's protocol ID
- 37586
- Other IDs
- R01HL128666
- Status last verified
- Sep 2026
- First submitted
- 2 Jan 2017
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escalating Proportion of Weight-Loss Maintainers Via Modules Prior to Weight Loss
- ClinicalTrials.gov ID
- NCT03014414
- Acronym / sponsor ID
- 37586
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Mar 2017 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fun First | Experimental | Behavioral: Fun FirstIf 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. |
| Weight Watchers | Active comparator | Behavioral: Weight WatchersIf 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]. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 27 <= BMI < 45 kg/m2
- Systolic blood pressure between 120-159 mmHg OR diastolic blood pressure between 80-99 mmHg. Can be on >=1 antihypertensive medications if on stable dose for past 3 months
- Systolic blood pressure <120 mmHg OR diastolic blood pressure <80 mmHg, if on stable dose of >=1 antihypertensive medications for past 3 months
Key exclusion criteria (29 listed)
- Elevated blood pressure: Systolic blood pressure >=160 mmHg OR diastolic blood pressure >=100 mmHg
- Have had a heart attack, stroke, coronary heart disease, congestive heart failure, or angina
- Have had coronary artery bypass surgery or cardiac catheterization such as percutaneous transluminal coronary angioplasty (PTCA), cath or stent placement
- Have diabetes
- Have medical contraindications to regular, unsupervised physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fun FirstLearn key enjoyable maintenance skills before losing weight | Behavioural | Fun First |
| Weight WatchersFocus on losing weight first via convenient meetings and personalized online tools | Behavioural | Weight Watchers |
Primary outcome
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
Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months
2 secondary outcomes
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
Change in systolic blood pressure from 0-36 months
Time frame: Baseline to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaela Kiernan, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fun First and Weight Watchers in people with Obesity, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 >=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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 5 Nov 2026.