Telehealth for Weight Maintenance of African-American Women ("Exercise Your Faith")
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Weight Loss Church Program
Telephone Counseling
Telehealth Support
Sponsored by

About this trial
This is an interventional prevention trial for Overweight focused on measuring Obesity, Body Weight Changes, Internet
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Telephone Support Only
Telehealth
Arm Description
These participants receive telephone support only during the weight maintenance phase.
These participants receive telehealth support (with Internet-enabled digital video recorders) during the weight maintenance phase. These participants also receive telephone support monthly.
Outcomes
Primary Outcome Measures
Body mass index
Secondary Outcome Measures
Physical activity
Dietary intake
Dietary intake includes fat, fiber, fruits and vegetables.
Full Information
NCT ID
NCT01402557
First Posted
July 25, 2011
Last Updated
December 26, 2016
Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01402557
Brief Title
Telehealth for Weight Maintenance of African-American Women ("Exercise Your Faith")
Official Title
Telehealth for Weight Maintenance of African-American Women
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Obesity, Body Weight Changes, Internet
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone Support Only
Arm Type
Active Comparator
Arm Description
These participants receive telephone support only during the weight maintenance phase.
Arm Title
Telehealth
Arm Type
Experimental
Arm Description
These participants receive telehealth support (with Internet-enabled digital video recorders) during the weight maintenance phase. These participants also receive telephone support monthly.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Church Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Counseling
Intervention Description
Following completion of the weight loss program, participants will receive monthly telephone counseling.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body mass index
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Physical activity
Time Frame
12 months
Title
Dietary intake
Description
Dietary intake includes fat, fiber, fruits and vegetables.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Gerber, MD, MPH
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24163236
Citation
Gerber BS, Schiffer L, Brown AA, Berbaum ML, Rimmer JH, Braunschweig CL, Fitzgibbon ML. Video telehealth for weight maintenance of African-American women. J Telemed Telecare. 2013 Jul;19(5):266-72. doi: 10.1177/1357633X13490901. Epub 2013 Jun 14.
Results Reference
result
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Telehealth for Weight Maintenance of African-American Women ("Exercise Your Faith")
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