Stanford Healthy Heart Study

NCT03014414 | Completed DMC

• 2 other identifiers: 37586R01HL128666
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Baseline to 36 months

• Change in systolic blood pressure from 0-36 months

  Baseline to 36 months

Other Outcomes (9)

• Change in self-reported enjoyment of healthy lifestyle behaviors from 0-2 months

  Baseline to 2 months

• Incremental cost-effectiveness ratio (U.S. Dollars per quality-adjusted life-years) of either weight-management intervention versus no intervention

  Baseline to 36 months

• Change in self-reported work productivity and activity from 6-36 months

  6 to 36 months

Study Arms (2)

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.

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. \[The study and investigative team have no financial relationship with Weight Watchers\].

Behavioral: Weight Watchers

Interventions

Fun First BEHAVIORAL

Learn key enjoyable maintenance skills before losing weight

Fun First

Weight Watchers BEHAVIORAL

Focus on losing weight first via convenient meetings and personalized online tools

Weight Watchers

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<= 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Stanford University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michaela Kiernan, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scholar

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 9, 2017
• Study Start: March 4, 2017
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)