Peer Support Dyads in Churches

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03463941
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 80
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.8
• Patients Per Site Per Month: 11.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peer Support and Chronic Disease; Obesity; Type II Diabetes; Cardiovascular Disease; Cancer	Behavioral: Peer Support Dyad Intervention	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Peer Support Dyads in a Health Promotion Program in African American Churches
• Actual Study Start Date: Jan 5, 2019
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: African American church members

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.

Outcome Measures

Primary Outcome Measures

1. Feasibility as Measured by Retention [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.

2. Number of Participants Who Agreed That Program Component Was Acceptable [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)

3. Health Educators' Perceptions of Feasibility as Measured by Semi-structured Interviews [Measured at Week 18]

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

Secondary Outcome Measures

1. Goal Attainment as Measured by BMI (Body Mass Index) [Week 18]

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

2. Goal Attainment as Measured by Weight in Pounds [Week 18]

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

3. Goal Attainment as Measured by Number of Participants Consuming 7 or More Fruits and Vegetables Per Day [Week 18]

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faithful Families Program	Raleigh	North Carolina	United States	27695

Sponsors and Collaborators

• Duke University
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Isaac Lipkus, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 8, 2020

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03463941
• Other Study ID Numbers: Pro00091547; 1F31NR017813-01
• First Posted: Mar 13, 2018
• Last Update Posted: Sep 2, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: African American; Faith institutions; Dyads; Health disparities
• Additional relevant MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Chronic Disease

Study Results

Participant Flow

Arm/Group Title	African American Church Members
Arm/Group Description	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.
Period Title: Overall Study
STARTED	80
COMPLETED	62
NOT COMPLETED	18

Baseline Characteristics

Arm/Group Title	African American Church Members
Arm/Group Description	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 Participants	80
Age (Count of Participants)
<=18 years	1 1.3%
Between 18 and 65 years	44 55%
>=65 years	35 43.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (11.8)
Sex: Female, Male (Count of Participants)
Female	67 83.8%
Male	13 16.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	80 100%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	80 100%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.9 (7.2)
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	198 (51.2)
Fruit and Vegetable Intake (Count of Participants)
Count of Participants [Participants]	1 1.3%
Days of Physical Activity (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	3.1 (2.1)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	African American Church Members
Arm/Group Description	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.
Measure Participants	65
Count of Participants [Participants]	62 77.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	African American Church Members
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		descriptive

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	African American Church Members
Arm/Group Description	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.
Measure Participants	62
Count of Participants [Participants]	61 76.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	African American Church Members
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		descriptive

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Health educators who were interviewed.

Arm/Group Title	Health Educators
Arm/Group Description	North Carolina Cooperative Extension nutrition educators who deliver the Faithful Families Thriving Communities curriculum to the faith community.
Measure Participants	4
Count of Participants [Participants]	4 5%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	African American Church Members
Arm/Group Description	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.
Measure Participants	62
Mean (Standard Deviation) [kg/m^2]	32 (6.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	African American Church Members
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	African American Church Members
Arm/Group Description	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.
Measure Participants	62
Mean (Standard Deviation) [pounds]	189 (44.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	African American Church Members
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	African American Church Members
Arm/Group Description	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.
Measure Participants	62
Count of Participants [Participants]	6 7.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	African American Church Members
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		descriptive

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed the study.

Arm/Group Title	African American Church Members
Arm/Group Description	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.
Measure Participants	62
Mean (Standard Deviation) [days]	4.5 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	African American Church Members
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	Baseline to 18 weeks
Arm/Group Title	African American Church Members
Arm/Group Description	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.
All Cause Mortality
	African American Church Members
	Affected / at Risk (%)	# Events
Total	0/80 (0%)
Serious Adverse Events
	African American Church Members
	Affected / at Risk (%)	# Events
Total	0/80 (0%)
Other (Not Including Serious) Adverse Events
	African American Church Members
	Affected / at Risk (%)	# Events
Total	0/80 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.