Evaluating Weight Loss Programs for Obese People at Risk for Heart Disease (The POWER Study)

High blood pressure, high cholesterol, and diabetes are all conditions that increase a
person's risk of developing heart disease. Many people with these conditions are also
overweight, and it is recommended that such people lose weight to reduce their risk of heart
disease. Previous weight loss studies have mainly examined in-person weight loss programs and
not Web- or e-mail-based weight loss programs. In addition, the primary care providers of
participants in these previous studies typically had no direct involvement in the programs.
This study will compare two weight loss programs—an In-Person Directed (IPD) program, which
is primarily comprised of in-person visits with health counselors, and a Call-Center Directed
(CCD) program, which uses only telephone, Web sites, and e-mail to contact and counsel
participants. These two programs will also be compared against a self-directed weight loss
program, which will act as a control group. The ultimate purpose of this study is to evaluate
the effectiveness of the IPD, CCD, and self-directed programs at increasing weight loss and
reducing risk factors in obese people at risk of developing heart disease.

This study will enroll overweight adults who have high blood pressure, high cholesterol, or
diabetes. Participants will attend a baseline study visit for weight and blood pressure
measurements. They will then be randomly assigned to participate in one of the following
three programs for 2 years.

1. IPD Program: This program will be directed by health counselors from Johns Hopkins
University. For Months 1 to 3, participants will attend a group or individual meeting
with a counselor each week. For Months 4 to 6, meetings will be held three times a
month; after Month 6, meetings will occur twice a month. Some of these meetings may be
held over the phone or by e-mail. Participants will keep a food and exercise diary and
they will enter their weight and calorie consumption on the study Web site. Study
researchers will provide participants' doctors with relevant information on
participants' weight loss.

2. CCD Program: This program will be directed by counselors from Healthways, Inc., a
company that assists individuals in managing their medical problems. All contacts will
occur by phone, e-mail, or the Web; there will be no in-person visits. Participants will
be able to review weight loss information on the study Web site. For Months 1 to 3,
participants will contact their counselors each week. For Months 4 to 6, contact with
study counselors will occur at least once a month; after Month 6, contact with study
counselors will occur every other month. Participants will keep a food and exercise
diary and they will enter their weight and calorie consumption on the study Web site.
Study researchers will provide participants' doctors with relevant information on
participants' weight loss.

3. Self-Directed Program: In this program, study staff will meet with participants once at
the beginning of the study, at which time participants will receive written information
about losing weight. Participants will also receive access to a study Web site that has
information about weight loss.

All participants will attend study visits at Months 6, 12, and 24 and at the end of the
study, which is anticipated to be in February 2011. Study researchers will also collect
information by phone at Month 18. At each study visit, participants will complete
questionnaires; provide blood samples; and undergo measurements of weight, waist, and blood
pressure. A portion of blood may be stored for future studies; this will be optional.

Inclusion Criteria:

- Hypertension, hypercholesterolemia, and/or diabetes mellitus, all of which are treated
with medication, measured in the clinic, or confirmed by primary care provider
(systolic blood pressure greater than or equal to 140 mm Hg, diastolic blood pressure
greater than or equal to 90 mm Hg, low density lipoprotein cholesterol [LDL-C] greater
than or equal to 130 mg/dL, or fasting blood sugar greater than 125 mg/dL)

- BMI of at least 30 to 50 kg/m2 and weight less than or equal to 400 lbs

- Willing to change diet, physical activity, and weight

- Willing to be randomly assigned to any of the study groups

- Patient of a participating doctor

- Patient self-reports two doctor visits in the 12 months before study entry

- Demonstrated use of Web and e-mail

- Access to Internet at least 4 days per week

- People with the following conditions are eligible to enroll in the study with primary
care provider approval:

1. Diabetes mellitus

2. Prior cardiovascular disease event more than 6 months before study entry

3. Known stable cardiovascular disease or peripheral vascular disease

4. Screen positive on Rose Questionnaire

Exclusion Criteria:

- Heart attack, stroke, or atherosclerotic cardiovascular disease (ASCVD) procedure in
the 6 months before study entry

- Serious medical condition that is likely to hinder accurate measurement of weight, for
which weight loss is not advisable, or that would cause weight loss [e.g., end-stage
renal disease (ESRD) on dialysis, cancer diagnosis or treatment in the 2 years before
study entry]

- Prior or planned bariatric surgery

- Use of prescription weight loss medication, including off-label drugs (e.g.,
topiramate, bupropion, byetta) or over-the-counter orlistat in the 6 months before
study entry

- Long-term use (in the 6 months before study entry) of medications likely to cause
weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine,
risperidone, clozapine)

- Unintentional weight loss in the 6 months before study entry (greater than or equal to
5% of body weight)

- Intentional weight loss in the 6 months before study entry (greater than or equal to
5% of body weight)

- Pregnant or breastfeeding in the 6 months before study entry

- Planning to become pregnant in the 2 years after study entry

- Planning to relocate from area in the 2 years after study entry

- Another member of the household is a study participant or study staff member

- Self-reported average consumption of more than 14 alcoholic drinks each week

- Psychiatric hospitalization in the 1 year before study entry

- Unstable angina

- Blood pressure greater than 160/100 mm Hg