Evaluating Weight Loss Programs for Obese People at Risk for Heart Disease (The POWER Study) (POWER)
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|ClinicalTrials.gov Identifier: NCT00783315|
Recruitment Status : Unknown
Verified April 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was: Active, not recruiting
First Posted : October 31, 2008
Last Update Posted : May 12, 2009
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Call-Center Directed (CCD) Weight Loss Program Behavioral: In-Person Directed (IPD) Weight Loss Program Behavioral: Self-Directed Weight Loss Program||Phase 3|
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.
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Practice-Based Opportunities for Weight Reduction Trial at Johns Hopkins|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||February 2011|
Active Comparator: 1
Self-Directed Weight Loss Program (Control Group)
Behavioral: Self-Directed Weight Loss Program
Participants will meet with study staff at the beginning of the study and will receive written information about weight loss.
Call-Center Directed (CCD) Weight Loss Program
Behavioral: Call-Center Directed (CCD) Weight Loss Program
This program will be implemented by trained counselors of Healthways, Inc., and will use telephone, Web, and e-mail contacts to engage participants. There will be no in-person visits.
In-Person Directed (IPD) Weight Loss Program
Behavioral: In-Person Directed (IPD) Weight Loss Program
This program will be primarily implemented through in-person visits (including group sessions) with health counselors at Johns Hopkins University. Telephone, Web, and e-mail contacts will occasionally be used.
- Weight [ Time Frame: Measured at Month 24 ]
- Blood pressure [ Time Frame: Measured at Month 24 ]
- Hypertension control [ Time Frame: Measured at Month 24 ]
- Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: Measured at Month 24 ]
- Framingham risk [ Time Frame: Measured at Month 24 ]
- Metabolic syndrome [ Time Frame: Measured at Month 24 ]
- Body mass index (BMI) [ Time Frame: Measured at Month 24 ]
- Lipid levels [ Time Frame: Measured at Month 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783315
|United States, Maryland|
|Baltimore, Maryland, United States, 21207|
|Principal Investigator:||Lawrence J. Appel, MD||Johns Hopkins University|