- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03463941
Peer Support Dyads in Churches
Peer Support Dyads in a Health Promotion Program in African American Churches
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27695
- Faithful Families Program
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: African American church members
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility as Measured by Retention
Time Frame: Baseline to week 18
|
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.
|
Baseline to week 18
|
Number of Participants Who Agreed That Program Component Was Acceptable
Time Frame: Measured at Week 18
|
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)
|
Measured at Week 18
|
Health Educators' Perceptions of Feasibility as Measured by Semi-structured Interviews
Time Frame: Measured at Week 18
|
Reported as number of health educators who found the program to be feasible.
|
Measured at Week 18
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal Attainment as Measured by BMI (Body Mass Index)
Time Frame: Week 18
|
Mixed models will be used to assess changes in participant BMI pre and post intervention.
|
Week 18
|
Goal Attainment as Measured by Weight in Pounds
Time Frame: Week 18
|
A mixed model using intraclass correlation will be used used to assess changes in participant weight pre and post intervention.
|
Week 18
|
Goal Attainment as Measured by Number of Participants Consuming 7 or More Fruits and Vegetables Per Day
Time Frame: Week 18
|
A mixed model using intraclass correlation will be used to assess changes in participant fruit and vegetable intake pre and post intervention.
|
Week 18
|
Goal Attainment as Measured by Days Per Week That Participants Exercised for 30 Minutes or More
Time Frame: Week 18
|
A mixed model using intraclass correlation will be used to assess changes in physical activity at weeks 1 and 18 pre and post intervention.
|
Week 18
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Isaac Lipkus, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00091547
- 1F31NR017813-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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