©2022 Stanford Medicine
Stanford Healthy Heart Study
Not Recruiting
Trial ID: NCT03014414
Purpose
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.
Official Title
Escalating Proportion of Weight-Loss Maintainers Via Modules Prior to Weight Loss
Stanford Investigator(s)
Eligibility
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)
Intervention(s):
behavioral: Fun First
behavioral: Weight Watchers
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michaela Kiernan, PhD
650-721-6684