Improving the Management of Obesity in Primary Care Practice (The Power-UP Trial)

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00826774

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

390

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Hypercholesterolemia Metabolic Syndrome Hypertension Diabetes	Behavioral: Usual Care Behavioral: Brief Lifestyle Counseling Behavioral: Enhanced Brief Lifestyle Counseling	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

390 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Practice-based Opportunities for Weight Reduction Trial at University of Pennsylvania

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ususal Care	Behavioral: Usual Care 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.
Experimental: Breif Lifestyle Counseling	Behavioral: Brief Lifestyle Counseling 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.
Experimental: Enhanced Brief Lifestyle Counseling	Behavioral: Enhanced Brief Lifestyle Counseling 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

Arm

Intervention/Treatment

Active Comparator: Ususal Care

Behavioral: Usual Care

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.

Experimental: Breif Lifestyle Counseling

Behavioral: Brief Lifestyle Counseling

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.

Experimental: Enhanced Brief Lifestyle Counseling

Behavioral: Enhanced Brief Lifestyle Counseling

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

Outcome Measures

Primary Outcome Measures

Weight [Measured at Month 24]

Secondary Outcome Measures

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]
Homeostasis model assessment of insulin resistance (HOMA-IR) [at 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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