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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Healthways, Inc.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00783315
First received: October 30, 2008
Last updated: May 11, 2009
Last verified: April 2009
  Purpose

Many people who are obese also have high blood pressure, high cholesterol, or diabetes—all conditions that can increase the risk of heart disease. This study will evaluate two programs that aim to encourage weight loss among obese people who are at risk for developing heart disease.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Practice-Based Opportunities for Weight Reduction Trial at Johns Hopkins

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Weight [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Hypertension control [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Framingham risk [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Metabolic syndrome [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Body mass index (BMI) [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
  • Lipid levels [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: January 2008
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: 2
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.
Experimental: 3
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783315

Locations
United States, Maryland
ProHealth
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
Healthways, Inc.
Investigators
Principal Investigator: Lawrence J. Appel, MD Johns Hopkins University
  More Information

No publications provided by National Heart, Lung, and Blood Institute (NHLBI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lawrence J. Appel, MD, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00783315     History of Changes
Other Study ID Numbers: 450, U01 HL087085
Study First Received: October 30, 2008
Last Updated: May 11, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Hypertension
Diabetes
Hypercholesterolemia

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014