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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03463941
Other study ID # Pro00091547
Secondary ID 1F31NR017813-01
Status Completed
Phase N/A
First received
Last updated
Start date January 5, 2019
Est. completion date July 31, 2019

Study information

Verified date August 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 31, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Peer Support Dyad Intervention
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.

Locations

Country Name City State
United States Faithful Families Program Raleigh North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to week 18
Primary 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) Measured at Week 18
Primary Health Educators' Perceptions of Feasibility as Measured by Semi-structured Interviews Reported as number of health educators who found the program to be feasible. Measured at Week 18
Secondary Goal Attainment as Measured by BMI (Body Mass Index) Mixed models will be used to assess changes in participant BMI pre and post intervention. Week 18
Secondary 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. Week 18
Secondary 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. Week 18
Secondary 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. Week 18
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