Stanford Healthy Heart Study

Not Recruiting

Trial ID: NCT03014414


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)


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

   - 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)


behavioral: Fun First

behavioral: Weight Watchers

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Michaela Kiernan, PhD