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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