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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
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Obesity, Body Weight Changes, Internet

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

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