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Telehealth for Weight Maintenance of African-American Women ("Exercise Your Faith")

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
University of Illinois
ClinicalTrials.gov Identifier:
NCT01402557
First received: July 25, 2011
Last updated: NA
Last verified: July 2011
History: No changes posted
  Purpose

Obesity can cause many health problems, including high blood pressure, diabetes, heart disease, and stroke. Although some people may lose weight through diet and exercise, many regain weight over time. There is a need to study new ways of helping people maintain their weight. The purpose of this research is to study the effect of a weight maintenance program provided through home television sets connected to the Internet.


Condition Intervention
Overweight
Obesity
 Behavioral: Weight Loss Church Program
Behavioral: Telephone Counseling
Behavioral: Telehealth Support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Telehealth for Weight Maintenance of African-American Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • Body mass index [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Dietary intake includes fat, fiber, fruits and vegetables.


Enrollment: 88
Study Start Date: August 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Telephone Support Only
These participants receive telephone support only during the weight maintenance phase.
 Behavioral: Weight Loss Church Program
An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants. All participants attend the church programs prior to the weight maintenance phase.
Behavioral: Telephone Counseling
Following completion of the weight loss program, participants will receive monthly telephone counseling.
Experimental: Telehealth
These participants receive telehealth support (with Internet-enabled digital video recorders) during the weight maintenance phase. These participants also receive telephone support monthly.
 Behavioral: Weight Loss Church Program
An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants. All participants attend the church programs prior to the weight maintenance phase.
Behavioral: Telephone Counseling
Following completion of the weight loss program, participants will receive monthly telephone counseling.
Behavioral: Telehealth Support
After the weight loss program, women will access the home weight maintenance telehealth program through Internet enabled digital video recorders connected to their television sets. The telehealth program includes three components: (1) Weekly Video: home access to weekly video programs including problem solving and relapse prevention strategies, as well as motivational stories; (2) Teleexercise: home access to updated video exercise programs; and (3) Electronic Communication: social support through online communication with other participants, and with an exercise and nutrition interventionist.

Detailed Description:

Rates of obesity in the United States have increased dramatically over the past four decades. Although research studies have demonstrated that weight loss is achievable through lifestyle modifications, the maintenance of weight reduction beyond six months remains a challenge.

This study will examine the feasibility of a telehealth program for weight maintenance. Telehealth is the delivery of health related services to promote healthy behaviors through the innovative use of technology, without the need for travel. The telehealth program will be accessible at home through Internet-enabled television sets. The telehealth program includes three components: (1) weekly video programs that discuss problem solving and relapse prevention strategies and include motivational stories; (2) regularly updated video exercise programs; and (3) online communication with other study participants and an exercise and nutrition specialist.

A randomized controlled trial will determine the feasibility and acceptability of the weight maintenance telehealth program. The study participants will be African-American women, as they have a higher prevalence of obesity with a disproportionate risk of related chronic diseases (e.g., diabetes). Two churches will collaborate with the University of Illinois at Chicago and assist in meeting the social, spiritual, and cultural needs of the participants. One hundred women will be recruited to participate in a one-year trial. The study includes a weight loss phase (Phase 1), and a weight maintenance phase (Phase 2). During Phase 1, all participants will attend a 12-week weight loss program held in the participating churches. Following completion of this program, one church will be assigned to be the intervention group, and the other church will be the comparison group. During Phase 2, participants in the intervention group will receive monthly telephone counseling plus access to the telehealth program, while the comparison group will only receive monthly telephone counseling. The specific aims of the study include: (1) to evaluate the effect of the telehealth program on change in body mass index; and (2) to evaluate the effect of the telehealth program on physical activity and fat, fiber, fruit and vegetable intake.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identification as an African-American or Black woman
  • Age 35-65 years
  • Body mass index 25-50 kg/m2
  • Physician approval to safely exercise if any positive answers on Physical Activity Readiness Questionnaire
  • Owns a television
  • Has a working telephone line

Exclusion Criteria:

  • Plans to move from the Chicago area during the coming year
  • Has a household member already in the study
  • Uses illicit drugs or drinks more than two alcoholic drinks daily
  • Pregnant, nursing, or planning pregnancy
  • Participating in an organized weight loss program or using pharmacotherapy for weight loss
  • Use an assistive device for ambulation, or cannot participate in exercise classes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402557

Sponsors and Collaborators
University of Illinois
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ben Gerber, MD, MPH University of Illinois
  More Information

No publications provided

Responsible Party: Ben Gerber, MD, MPH, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01402557     History of Changes
Other Study ID Numbers: 2006-0836, R21DK078352
Study First Received: July 25, 2011
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois:
Obesity
Body Weight Changes
Internet

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

ClinicalTrials.gov processed this record on June 18, 2013