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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Hypercholesterolemia, Metabolic Syndrome, Hypertension, Diabetes

Intervention / Treatment
-----------------
* Behavioral: Usual Care
* Behavioral: Brief Lifestyle Counseling
* Behavioral: Enhanced Brief Lifestyle Counseling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ususal Care<br> | Behavioral: Usual Care<br>* 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.<br>|
| Experimental: Breif Lifestyle Counseling<br> | Behavioral: Brief Lifestyle Counseling<br>* 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.<br>|
| Experimental: Enhanced Brief Lifestyle Counseling<br> | Behavioral: Enhanced Brief Lifestyle Counseling<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Measured at Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Weight, Overweight, Hypertension, Hyperglycemia