Evaluating Weight Loss Programs for Obese People at Risk for Heart Disease (The POWER Study)

Completed · Not applicable

Conditions studied: Obesity

In brief

Many people who are obese also have high blood pressure, high cholesterol, or diabetes-all conditions that can increase the risk of heart disease. This study will evaluate two programs that aim to encourage weight loss among obese people who are at risk for developing heart disease.

Key facts

Study ID

NCT00783315

Run by

Johns Hopkins University

People needed

415

Starts

2008-02-01

Expected to finish

2011-02-28

Last updated by the study team

2018-09-05

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hypertension, hypercholesterolemia, and/or diabetes mellitus, all of which are treated with medication, measured in the clinic, or confirmed by primary care provider (systolic blood pressure greater than or equal to 140 mm Hg, diastolic blood pressure greater than or equal to 90 mm Hg, low density lipoprotein cholesterol [LDL-C] greater than or equal to 130 mg/dL, or fasting blood sugar greater than 125 mg/dL)
• BMI of at least 30 to 50 kg/m2 and weight less than or equal to 400 lbs
• Willing to change diet, physical activity, and weight
• Willing to be randomly assigned to any of the study groups
• Patient of a participating doctor
• Patient self-reports two doctor visits in the 12 months before study entry
• Demonstrated use of Web and e-mail
• Access to Internet at least 4 days per week
• People with the following conditions are eligible to enroll in the study with primary care provider approval:
• Diabetes mellitus
• Prior cardiovascular disease event more than 6 months before study entry
• Known stable cardiovascular disease or peripheral vascular disease
• Screen positive on Rose Questionnaire

You may not qualify if…

• Heart attack, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in the 6 months before study entry
• Serious medical condition that is likely to hinder accurate measurement of weight, for which weight loss is not advisable, or that would cause weight loss [e.g., end-stage renal disease (ESRD) on dialysis, cancer diagnosis or treatment in the 2 years before study entry]
• Prior or planned bariatric surgery
• Use of prescription weight loss medication, including off-label drugs (e.g., topiramate, bupropion, byetta) or over-the-counter orlistat in the 6 months before study entry
• Long-term use (in the 6 months before study entry) of medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine)
• Unintentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
• Intentional weight loss in the 6 months before study entry (greater than or equal to 5% of body weight)
• Pregnant or breastfeeding in the 6 months before study entry
• Planning to become pregnant in the 2 years after study entry
• Planning to relocate from area in the 2 years after study entry
• Another member of the household is a study participant or study staff member
• Self-reported average consumption of more than 14 alcoholic drinks each week
• Psychiatric hospitalization in the 1 year before study entry
• Unstable angina
• Blood pressure greater than 160/100 mm Hg

Where it is running

• ProHealth — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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