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