Obesity
Conditions
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.
Interventions
BEHAVIORALFun First
Learn key enjoyable maintenance skills before losing weight
BEHAVIORALWeight Watchers
Focus on losing weight first via convenient meetings and personalized online tools
Sponsors
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(BMI): * 27 \<= BMI \< 45 kg/m2 Inclusion Criteria (Elevated Blood Pressure): * 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
Exclusion criteria
(Blood Pressure): * Elevated blood pressure: Systolic blood pressure \>=160 mmHg OR diastolic blood pressure \>=100 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to 36 months | Participants will be weighed during in-person visits at the research clinic at 0, 6, 12, 24, and 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline 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 |
| Change in systolic blood pressure from 0-36 months | Baseline 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichaela Kiernan, PhD
Stanford University
Outcome results
None listed