Peer Support and Chronic DiseaseNCT03463941
Peer Support Dyads in Churches
A study testing Peer Support Dyad Intervention in people with Peer Support and Chronic Disease and Obesity, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peer Support and Chronic Disease, Obesity, Type II Diabetes
- What is being tested?
- Peer Support Dyad Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2019to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Faithful Families Program
Raleigh, North Carolina, 27695
About this study
Official title: Peer Support Dyads in a Health Promotion Program in African American Churches
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.
- Conditions
- Peer Support and Chronic Disease, Obesity, Type II Diabetes, Cardiovascular Disease, Cancer
- Being tested
- Peer Support Dyad Intervention
- Keywords
- African American, Faith institutions, Dyads, Health disparities
- Medical subject headings
- Chronic Disease, Obesity, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Support Dyad InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| African American church members | Experimental | Not described Receives: Behavioral: Peer Support Dyad Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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: 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: Measured at Week 18
Secondary outcomes (4)
Goal Attainment as Measured by BMI (Body Mass Index)
Mixed models will be used to assess changes in participant BMI pre and post intervention.
Measured: Week 18
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.
Measured: Week 18
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.
Measured: Week 18
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.
Measured: Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start5 Jan 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peer Support and Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Isaac Lipkus, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463941
- Sponsor's protocol ID
- Pro00091547
- Other IDs
- 1F31NR017813-01
- Status last verified
- Aug 2020
- First submitted
- 7 Mar 2018
- Last updated
- 2 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support Dyads in a Health Promotion Program in African American Churches
- ClinicalTrials.gov ID
- NCT03463941
- Acronym / sponsor ID
- Pro00091547
- Conditions
- Peer Support and Chronic Disease, Obesity, Type II Diabetes, Cardiovascular Disease, Cancer
- Keywords
- African American, Faith institutions, Dyads, Health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Posted 2 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| African American church members | Experimental | Behavioral: Peer Support Dyad Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Support Dyad InterventionPhase 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. | Behavioural | African American church members |
Primary outcome
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.
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)
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.
4 secondary outcomes
Goal Attainment as Measured by BMI (Body Mass Index)
Time frame: Week 18
Goal Attainment as Measured by Weight in Pounds
Time frame: Week 18
Goal Attainment as Measured by Number of Participants Consuming 7 or More Fruits and Vegetables Per Day
Time frame: Week 18
Goal Attainment as Measured by Days Per Week That Participants Exercised for 30 Minutes or More
Time frame: Week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Lipkus principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support Dyad Intervention in people with Peer Support and Chronic Disease and Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Measured by Retention (time frame: Baseline to week 18). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.