Status:
COMPLETED
Improving the Management of Obesity in Primary Care Practice (The Power-UP Trial)
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Hypercholesterolemia
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare three methods of achieving weight loss in primary care medical practice. The study will be conducted in six primary care practices. Weight management will be pro...
Detailed Description
Obesity, defined by a body mass index (BMI) ≥ 30 kg/m2, affects more than 31% of American adults. Additionally, nearly one-quarter of U.S. adults meet criteria for the metabolic syndrome, a clustering...
Eligibility Criteria
Inclusion
- Age ≥ 21 years
- BMI 30-50 kg/m2 and weight ≤ 400 lbs.
- At least 2 of 5 criteria for metabolic syndrome
- Elevated waist circumference (\> 102 cm for men, \> 88 cm for women)
- Elevated blood pressure (≥ 130/85 mmHg)
- Impaired fasting glucose (≥ 100 mg/dl)
- Elevated triglycerides (≥ 150 mg/dl)
- Low HDL cholesterol (\< 40 for men, \< 50 mg/dl for women)
- Willing to change diet, physical activity and weight
- Willing to accept randomization to each group
- Able to give informed consent
- Patient of participating PCP
- Persons with the following conditions are eligible with PCP approval:
- Diabetes mellitus
- Prior CVD event \> 6 months before randomization
- Stable CVD or peripheral vascular disease
Exclusion
- Serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss (e.g., end-stage renal disease on dialysis, cancer diagnosis or treatment within 2 yrs)
- Prior or planned bariatric surgery
- Chronic use (at least past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium, olanzapine, risperidone, clozapine)
- Unintentional weight loss within 6 months of enrollment (≥ 5% of body weight)
- Intentional weight loss within 6 months of enrollment (≥ 5% of body weight)
- Pregnant or nursing within past 6 months
- Plans to relocate from the area within 2 years
- Another member of household is a study participant or staff in the trial
- Consumes \> 14 alcoholic drinks per week
- Current use of illicit substances
- Psychiatric hospitalization in last year
- Psychiatric condition likely to impair adherence to treatment (e.g., schizophrenia)
- Blood pressure ≥ 160/100 mmHg; patient may be re-screened in 1 month
- Principal Investigator or PCP discretion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00826774
Start Date
January 1 2008
End Date
June 1 2011
Last Update
May 15 2012
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