Peer Support Dyads in Churches
Primary Purpose
Peer Support and Chronic Disease, Obesity, Type II Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Support Dyad Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Peer Support and Chronic Disease focused on measuring African American, Faith institutions, Dyads, Health disparities
Eligibility Criteria
Inclusion Criteria:
- The inclusion criteria will be churches with mostly African American members.
- Participant criteria will be: ages >=18 or older who identify as African American
- Attend church at least once per week
- Speak, read and write English
- Willing to complete study activities and assessments
- Able to engage in moderate physical activity. (e.g., walking - based on their own activity level and assessment).
Exclusion Criteria:
-
Sites / Locations
- Faithful Families Program
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
African American church members
Arm Description
Outcomes
Primary Outcome Measures
Feasibility as Measured by Retention
Retention will be calculated from the number of participants who continue to Phase II out of the number who complete Phase I (>50% attendance), and the attrition rate.
Number of Participants Who Agreed That Program Component Was Acceptable
Measured by ten item feasibility survey, scored based on 5-point Likert scale administered at week 18, the last week of the program. Feasibility was measured on a scale of 1-5, where 1=strongly disagree that program component was acceptable or feasible, and 5=strongly agree that program component was acceptable or feasible)
Health Educators' Perceptions of Feasibility as Measured by Semi-structured Interviews
Reported as number of health educators who found the program to be feasible.
Secondary Outcome Measures
Goal Attainment as Measured by BMI (Body Mass Index)
Mixed models will be used to assess changes in participant BMI pre and post intervention.
Goal Attainment as Measured by Weight in Pounds
A mixed model using intraclass correlation will be used used to assess changes in participant weight pre and post intervention.
Goal Attainment as Measured by Number of Participants Consuming 7 or More Fruits and Vegetables Per Day
A mixed model using intraclass correlation will be used to assess changes in participant fruit and vegetable intake pre and post intervention.
Goal Attainment as Measured by Days Per Week That Participants Exercised for 30 Minutes or More
A mixed model using intraclass correlation will be used to assess changes in physical activity at weeks 1 and 18 pre and post intervention.
Full Information
NCT ID
NCT03463941
First Posted
March 7, 2018
Last Updated
August 18, 2020
Sponsor
Duke University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT03463941
Brief Title
Peer Support Dyads in Churches
Official Title
Peer Support Dyads in a Health Promotion Program in African American Churches
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 5, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Nursing Research (NINR)
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 purpose of this study is to explore how working with a partner can influence participation in a church wellness program. There are many different types of church wellness programs. Church members are more likely to participate and achieve goals in these programs when they have peer support. The researcher would like to know what African American men and women think about working with a support partner. This information will help researchers design better church wellness programs. The participants are being asked to take part in this research because the investigators believe that it is helpful to share feelings and thoughts about experiences working with a partner to achieve health goals. This knowledge will be used to create church wellness programs that will help African American men and women prevent disease and live healthier lives.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peer Support and Chronic Disease, Obesity, Type II Diabetes, Cardiovascular Disease, Cancer
Keywords
African American, Faith institutions, Dyads, Health disparities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
African American church members
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Peer Support Dyad Intervention
Intervention Description
Phase I: At baseline and at post-intervention, participant height, weight, BMI, fruit and vegetable intake and exercise habits will be measured. Participants will complete surveys and meet each week to learn about nutrition and exercise.
Phase II: Dyads will attend a communication training session to discuss 1) benefits of working with a partner; 2) supportive communication tips; and 3) expected activities for the next 8 weeks, including filling out daily logs. After the training session, the dyads will work together to achieve their health goals. The dyads will return to the church for two check in sessions. At these sessions, participants will turn in their logs, and be weighed. At the end of the intervention, BMI will be reassessed, and surveys and interviews will be completed.
Primary Outcome Measure Information:
Title
Feasibility as Measured by Retention
Description
Retention will be calculated from the number of participants who continue to Phase II out of the number who complete Phase I (>50% attendance), and the attrition rate.
Time Frame
Baseline to week 18
Title
Number of Participants Who Agreed That Program Component Was Acceptable
Description
Measured by ten item feasibility survey, scored based on 5-point Likert scale administered at week 18, the last week of the program. Feasibility was measured on a scale of 1-5, where 1=strongly disagree that program component was acceptable or feasible, and 5=strongly agree that program component was acceptable or feasible)
Time Frame
Measured at Week 18
Title
Health Educators' Perceptions of Feasibility as Measured by Semi-structured Interviews
Description
Reported as number of health educators who found the program to be feasible.
Time Frame
Measured at Week 18
Secondary Outcome Measure Information:
Title
Goal Attainment as Measured by BMI (Body Mass Index)
Description
Mixed models will be used to assess changes in participant BMI pre and post intervention.
Time Frame
Week 18
Title
Goal Attainment as Measured by Weight in Pounds
Description
A mixed model using intraclass correlation will be used used to assess changes in participant weight pre and post intervention.
Time Frame
Week 18
Title
Goal Attainment as Measured by Number of Participants Consuming 7 or More Fruits and Vegetables Per Day
Description
A mixed model using intraclass correlation will be used to assess changes in participant fruit and vegetable intake pre and post intervention.
Time Frame
Week 18
Title
Goal Attainment as Measured by Days Per Week That Participants Exercised for 30 Minutes or More
Description
A mixed model using intraclass correlation will be used to assess changes in physical activity at weeks 1 and 18 pre and post intervention.
Time Frame
Week 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The inclusion criteria will be churches with mostly African American members.
Participant criteria will be: ages >=18 or older who identify as African American
Attend church at least once per week
Speak, read and write English
Willing to complete study activities and assessments
Able to engage in moderate physical activity. (e.g., walking - based on their own activity level and assessment).
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isaac Lipkus
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faithful Families Program
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27695
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Peer Support Dyads in Churches
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