Trial Outcomes & Findings for Peer Support Dyads in Churches (NCT NCT03463941)

NCT ID: NCT03463941

Last Updated: 2020-09-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: Baseline to week 18
• Results posted on: 2020-09-02

Participant Flow

Participant milestones

Measure	African American Church Members 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.
Overall Study STARTED	80
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Peer Support Dyads in Churches

Baseline characteristics by cohort

Measure	African American Church Members n=80 Participants 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.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	35 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	80 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	80 Participants n=5 Participants
Body Mass Index (BMI)	32.9 kg/m^2 STANDARD_DEVIATION 7.2 • n=5 Participants
Weight	198 pounds STANDARD_DEVIATION 51.2 • n=5 Participants
Fruit and Vegetable Intake	1 Participants n=5 Participants
Days of Physical Activity	3.1 days STANDARD_DEVIATION 2.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to week 18

Population: Participants who completed Phase I (\>50% attendance).

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.

Outcome measures

Measure

African American Church Members n=65 Participants 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.

Feasibility as Measured by Retention

62 Participants

PRIMARY outcome

Timeframe: Measured at Week 18

Population: Participants who completed the study.

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)

Outcome measures

Measure

African American Church Members n=62 Participants 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.

Number of Participants Who Agreed That Program Component Was Acceptable

61 Participants

PRIMARY outcome

Timeframe: Measured at Week 18

Population: Health educators who were interviewed.

Reported as number of health educators who found the program to be feasible.

Outcome measures

Measure

African American Church Members n=4 Participants 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.

Health Educators' Perceptions of Feasibility as Measured by Semi-structured Interviews

4 Participants

SECONDARY outcome

Timeframe: Week 18

Population: Participants who completed the study.

Mixed models will be used to assess changes in participant BMI pre and post intervention.

Outcome measures

Measure

African American Church Members n=62 Participants 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.

Goal Attainment as Measured by BMI (Body Mass Index)

32 kg/m^2 Standard Deviation 6.8

SECONDARY outcome

Timeframe: Week 18

Population: Participants who completed the study.

A mixed model using intraclass correlation will be used used to assess changes in participant weight pre and post intervention.

Outcome measures

Measure

African American Church Members n=62 Participants 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.

Goal Attainment as Measured by Weight in Pounds

189 pounds Standard Deviation 44.5

SECONDARY outcome

Timeframe: Week 18

Population: Participants who completed the study.

A mixed model using intraclass correlation will be used to assess changes in participant fruit and vegetable intake pre and post intervention.

Outcome measures

Measure

African American Church Members n=62 Participants 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.

Goal Attainment as Measured by Number of Participants Consuming 7 or More Fruits and Vegetables Per Day

6 Participants

SECONDARY outcome

Timeframe: Week 18

Population: Participants who completed the study.

A mixed model using intraclass correlation will be used to assess changes in physical activity at weeks 1 and 18 pre and post intervention.

Outcome measures

Measure

African American Church Members n=62 Participants 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.

Goal Attainment as Measured by Days Per Week That Participants Exercised for 30 Minutes or More

4.5 days Standard Deviation 2.2

Adverse Events

African American Church Members

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Cherie Conley

Duke School of Nursing

Phone: 2166597128

Email: cherie.conley@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place