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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
University of Southern Mississippi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

    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
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    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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