The Church as a Bridge to Deliver Health Resources Via Telehealth
Primary Purpose
Obesity, Diet, Food, and Nutrition, Church
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Church Bridge Project
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- BMI >/=30
- Must have elementary aged child (5-11 years) in household
Exclusion Criteria:
- Any health condition where weight loss is contraindicated
- Complicated disease states (ie., advanced renal disease or heart failure)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Weight loss program
Arm Description
Participants will attend a 12 session weight loss program accompanied by maintenance support delivered by a church. Program will include peer education, telenutrition counseling and mobile health feedback.
Outcomes
Primary Outcome Measures
Change in weight at six months
Secondary Outcome Measures
Full Information
NCT ID
NCT02773069
First Posted
May 10, 2016
Last Updated
October 25, 2017
Sponsor
University of Southern Mississippi
Collaborators
Southeast Mississippi Rural Health Initiative, MSU Extension- Stone County
1. Study Identification
Unique Protocol Identification Number
NCT02773069
Brief Title
The Church as a Bridge to Deliver Health Resources Via Telehealth
Official Title
The Church as a Bridge to Deliver Health Resources Via Telehealth to Alleviate Obesity and Chronic Disease Disparities in Rural African Americans of Mississippi
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern Mississippi
Collaborators
Southeast Mississippi Rural Health Initiative, MSU Extension- Stone County
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed Church Bridge intervention project will provide an innovative, evidence-based and technology supported, health intervention model for Southern, African American, and rural populations who continue to be disparately burdened by obesity and associated co-morbidities (i.e., hypertension, diabetes, cardiovascular disease). By targeting young adults (21-50 years of age) with families, the project will contribute to the long-term reduction of preventable chronic disease and related health care costs for the public.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diet, Food, and Nutrition, Church, Healthcare Disparities, Minority Health, Mobile Health, Telehealth, Community-based Participatory Research, Primary Health Care, Weight Loss Programs, Health Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weight loss program
Arm Type
Experimental
Arm Description
Participants will attend a 12 session weight loss program accompanied by maintenance support delivered by a church. Program will include peer education, telenutrition counseling and mobile health feedback.
Intervention Type
Behavioral
Intervention Name(s)
Church Bridge Project
Intervention Description
Community-based participatory research combining efforts of academic researchers, church leaders, primary care providers and community stakeholders.
Primary Outcome Measure Information:
Title
Change in weight at six months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI >/=30
Must have elementary aged child (5-11 years) in household
Exclusion Criteria:
Any health condition where weight loss is contraindicated
Complicated disease states (ie., advanced renal disease or heart failure)
12. IPD Sharing Statement
Learn more about this trial
The Church as a Bridge to Deliver Health Resources Via Telehealth
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