Clinical trial NCT03014414: Stanford Healthy Heart Study
Official title: Escalating Proportion of Weight-Loss Maintainers Via Modules Prior to Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-01-09
Enrollment: 321
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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
* 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

Exclusion Criteria (Medications):

* 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)

Exclusion Criteria (Weight and diet related):

* 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)

Exclusion Criteria (Behavioral related):

* 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)

Primary outcomes:
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
timeFrame: Baseline to 36 months
Secondary outcomes:
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
timeFrame: Baseline to 36 months
measure: Change in systolic blood pressure from 0-36 months
timeFrame: Baseline to 36 months
Other outcomes:
measure: Change in self-reported enjoyment of healthy lifestyle behaviors from 0-2 months
timeFrame: Baseline to 2 months
measure: Incremental cost-effectiveness ratio (U.S. Dollars per quality-adjusted life-years) of either weight-management intervention versus no intervention
timeFrame: Baseline to 36 months
measure: Change in self-reported work productivity and activity from 6-36 months
timeFrame: 6 to 36 months
measure: Change in self-reported costs of participating in the weight-management interventions from 6-36 months
timeFrame: 6 to 36 months
measure: Change in self-reported quality of life from 0-36 months
timeFrame: Baseline to 36 months
measure: Change in weight in kilograms from 0-36 months, assessed by clinic scales
timeFrame: Baseline to 36 months
measure: Proportion of participants who lose >=5% of their initial body weight from 0-36 months, assessed by clinic scales
timeFrame: Baseline to 36 months
measure: Change in weight in kilograms from 0-36 months, assessed by cellular scales
timeFrame: Baseline to 36 months
measure: Proportion of participants who lose >=5% of their initial body weight from 0-36 months, assessed by cellular scales
timeFrame: Baseline to 36 months
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Michaela Kiernan, PhD
role: PRINCIPAL_INVESTIGATOR
References: