Improving the Management of Obesity in Primary Care Practice (The Power-UP Trial) (Power-UP)
Primary Purpose
Obesity, Hypercholesterolemia, Metabolic Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Usual Care
Brief Lifestyle Counseling
Enhanced Brief Lifestyle Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Body Weight, Overweight, Hypertension, Hyperglycemia
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Ususal Care
Breif Lifestyle Counseling
Enhanced Brief Lifestyle Counseling
Arm Description
Outcomes
Primary Outcome Measures
Weight
Secondary Outcome Measures
Prevalence of the metabolic syndrome
Blood Pressure
Lipid levels
Sexual function
Mood
Homeostasis model assessment of insulin resistance (HOMA-IR)
Full Information
NCT ID
NCT00826774
First Posted
January 20, 2009
Last Updated
May 14, 2012
Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00826774
Brief Title
Improving the Management of Obesity in Primary Care Practice (The Power-UP Trial)
Acronym
Power-UP
Official Title
Practice-based Opportunities for Weight Reduction Trial at University of Pennsylvania
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 of clinical signs (i.e., elevated waist circumference, blood pressure, glucose or triglycerides, decreased HDL cholesterol) that is associated with increased risk of cardiovascular death. Behavior modification programs and pharmacologic interventions for obesity typically result in an 8% to 10% loss of initial body weight. Losses of this magnitude are associated with clinically significant improvements in metabolic parameters among obese persons. The availability of traditional behavioral weight control programs, however, is limited as many of these programs are based in academic medical centers. Furthermore, pharmacotherapy is seldom covered by third-party payers. Thus, there are concerns about the accessibility of these interventions to the many obese individuals who could benefit from weight loss.
The purpose of the study is to improve the management of obesity in primary care practice, where obesity is commonly encountered but infrequently addressed. Three hundred and ninety persons at 6 primary care practices within the University of Pennsylvania Health System will be randomized to one of three 2-year interventions: Usual Care, Brief Lifestyle Counseling, or Enhanced Brief Lifestyle Counseling. After training in obesity management and intervention strategies, each site will enroll approximately 65 individuals with a BMI of 30-50 kg/m2 plus two or more components of the metabolic syndrome. Participants in the Usual Care condition (N=130) will receive educational materials plus quarterly visits with a primary care provider (PCP). Those in the Brief Lifestyle Counseling condition (N=130) will receive the same PCP visits, plus 26 brief counseling sessions with an auxiliary health care provider (e.g., a medical assistant), on-site or by phone. Participants in the Enhanced Brief Lifestyle Counseling condition (N=130) will additionally receive the same treatment as those in the Brief Lifestyle Counseling group, plus the choice of adjunctive meal replacements or pharmacotherapy.
Two-year changes in weight will be compared across groups. Participants who receive the Brief Lifestyle Counseling and the Enhanced Brief Lifestyle Counseling interventions are predicted to achieve greater weight loss than those who receive Usual Care. A secondary hypothesis is that participants in Enhanced Brief Lifestyle Counseling condition will lose significantly more weight at month 24 than participants in the Brief Lifestyle Counseling group. Secondary analysis will also compare changes in the metabolic syndrome (and its individual components), mood, quality of life, dietary intake, eating behavior, appetite, physical activity and sexual function, as well as cost-effectiveness, among the three conditions. Intervention protocols and study results will be disseminated to other health care providers and payers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypercholesterolemia, Metabolic Syndrome, Hypertension, Diabetes
Keywords
Body Weight, Overweight, Hypertension, Hyperglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ususal Care
Arm Type
Active Comparator
Arm Title
Breif Lifestyle Counseling
Arm Type
Experimental
Arm Title
Enhanced Brief Lifestyle Counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Lifestyle Counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Brief Lifestyle Counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
Weight
Time Frame
Measured at Month 24
Secondary Outcome Measure Information:
Title
Prevalence of the metabolic syndrome
Time Frame
at 24 months
Title
Blood Pressure
Time Frame
at 24 months
Title
Lipid levels
Time Frame
at 24 months
Title
Sexual function
Time Frame
at 24 months
Title
Mood
Time Frame
at 24 months
Title
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame
at 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Wadden, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22082239
Citation
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.
Results Reference
derived
PubMed Identifier
20573639
Citation
Yeh 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.
Results Reference
derived
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Improving the Management of Obesity in Primary Care Practice (The Power-UP Trial)
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