Improving the Management of Obesity in Primary Care Practice (The Power-UP Trial)
Power-UP
Practice-based Opportunities for Weight Reduction Trial at University of Pennsylvania
2 other identifiers
interventional
390
0 countries
N/A
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 provided to a total of 390 obese patients (who have 2 or more components of the metabolic syndrome) by their own primary care providers, in conjunction with the practices' auxiliary health professionals, including medical assistants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Jan 2008
Longer than P75 for phase_3 obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMay 15, 2012
May 1, 2012
3.1 years
January 20, 2009
May 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
Measured at Month 24
Secondary Outcomes (6)
Prevalence of the metabolic syndrome
at 24 months
Blood Pressure
at 24 months
Lipid levels
at 24 months
Sexual function
at 24 months
Mood
at 24 months
- +1 more secondary outcomes
Study Arms (3)
Ususal Care
ACTIVE COMPARATORBreif Lifestyle Counseling
EXPERIMENTALEnhanced Brief Lifestyle Counseling
EXPERIMENTALInterventions
Participants in this group will receive usual medical care, provided by their own primary care providers (PCPs). PCPs also will provide participants recommendations for weight management at quarterly-scheduled visits.
These participants, like those in the Usual Care group, will receive the same PCP visits, plus monthly brief counseling sessions with an auxiliary health care provider (e.g., a medical assistant), on-site or by phone.
These participants will receive the same intervention as those in the Brief Lifestyle Counseling condition, including quarterly PCP visits and monthly sessions with a medical assistant who will instruct them in lifestyle modification. These individuals also will select, in consultation with their PCP, the use of either meal replacements or weight loss medication, to facilitate the induction and maintenance of weight loss
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Wadden TA, Volger S, Sarwer DB, Vetter ML, Tsai AG, Berkowitz RI, Kumanyika S, Schmitz KH, Diewald LK, Barg R, Chittams J, Moore RH. A two-year randomized trial of obesity treatment in primary care practice. N Engl J Med. 2011 Nov 24;365(21):1969-79. doi: 10.1056/NEJMoa1109220. Epub 2011 Nov 14.
PMID: 22082239DERIVEDYeh HC, Clark JM, Emmons KE, Moore RH, Bennett GG, Warner ET, Sarwer DB, Jerome GJ, Miller ER, Volger S, Louis TA, Wells B, Wadden TA, Colditz GA, Appel LJ. Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group. Clin Trials. 2010 Aug;7(4):322-32. doi: 10.1177/1740774510374213. Epub 2010 Jun 23.
PMID: 20573639DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas A Wadden, PhD
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2009
First Posted
January 22, 2009
Study Start
January 1, 2008
Primary Completion
February 1, 2011
Study Completion
June 1, 2011
Last Updated
May 15, 2012
Record last verified: 2012-05