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Stanford Healthy Heart Study

Not Applicable
Completed
Conditions
Obesity
Interventions
Behavioral: Fun First
Behavioral: Weight Watchers
Registration Number
NCT03014414
Lead Sponsor
Stanford University
Brief 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
321
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Fun FirstFun 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 WatchersWeight 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. \[The study and investigative team have no financial relationship with Weight Watchers\].
Primary Outcome Measures
NameTimeMethod
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 scalesBaseline to 36 months

Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months

Secondary Outcome Measures
NameTimeMethod
Change in systolic blood pressure from 0-36 monthsBaseline to 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

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 scalesBaseline to 36 months

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

Trial Locations

Locations (1)

Stanford University School of Medicine

🇺🇸

Palo Alto, California, United States

Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
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