NCT03463941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

January 5, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 2, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

7 months

First QC Date

March 7, 2018

Results QC Date

July 20, 2020

Last Update Submit

August 18, 2020

Conditions

Keywords

African AmericanFaith institutionsDyadsHealth disparities

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Goal Attainment as Measured by BMI (Body Mass Index)

    Week 18

  • Goal Attainment as Measured by Weight in Pounds

    Week 18

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

    Week 18

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

    Week 18

Study Arms (1)

African American church members

EXPERIMENTAL
Behavioral: Peer Support Dyad Intervention

Interventions

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.

African American church members

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faithful Families Program

Raleigh, North Carolina, 27695, United States

Location

MeSH Terms

Conditions

Chronic DiseaseObesityDiabetes Mellitus, Type 2Cardiovascular DiseasesNeoplasms

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Cherie Conley
Organization
Duke School of Nursing

Study Officials

  • Isaac Lipkus

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 13, 2018

Study Start

January 5, 2019

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

September 2, 2020

Results First Posted

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations