An interventional study of Peer Support Dyad Intervention in Peer Support and Chronic Disease, Obesity and Type II Diabetes, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-02.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
Among 61 studies in Obesity by Duke University — 4 open to participants now, 4 under way, none of them phase 3. Obesity · Duke University.
Among the 61 studies in Obesity by Duke University, this one is the 28th largest by enrollment of the 51 interventional ones that give a count, is one of 4 that started in 2019, is one of 46 with no phase, and was the 39th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →4 of the 61 studies in Obesity by Duke University are open now, in 1 country. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 6–17
Duke University · Sites in United States
Ages 6–14 · Healthy volunteers
Duke University · Sites in United States
Ages 50–95 · Healthy volunteers
Duke University · Sites in United States
Ages 12–17 · Healthy volunteers
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
61 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 4 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 84 across the 51 interventional studies, 49 across the 10 observational. Of the 55 that completed or were terminated, 12 (22%) have results posted.
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Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
2 of the studies in Obesity by Duke University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06595251Duke UniversityCommunity Park-Based Programs for Health Promotion: Fit2Play Prospective Cohort Study | 2027-05-17 |
| NCT05945355Duke UniversityMechanistic Study of Inspiratory Training in Childhood Asthma (MICA) | 2027-10-30 |
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Among the 61 studies in Obesity by Duke University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 80 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Chronic Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Exclusion Criteria:
-
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.
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.
Time frame: 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)
Time frame: 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.
Time frame: Measured at Week 18
Goal Attainment as Measured by BMI (Body Mass Index)
Mixed models will be used to assess changes in participant BMI pre and post intervention.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 18
| Milestone | African American Church Members |
|---|---|
| Started | 80 |
| Completed | 62 |
| Not completed | 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.
| Participants | African American Church Members |
|---|---|
| Feasibility as Measured by Retention | 62 |
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)
| Participants | African American Church Members |
|---|---|
| Number of Participants Who Agreed That Program Component Was Acceptable | 61 |
Reported as number of health educators who found the program to be feasible.
| Participants | Health Educators |
|---|---|
| Health Educators' Perceptions of Feasibility as Measured by Semi-structured Interviews | 4 |
Mixed models will be used to assess changes in participant BMI pre and post intervention.
| kg/m^2 | African American Church Members |
|---|---|
| Goal Attainment as Measured by BMI (Body Mass Index) | 32 ± 6.8 |
A mixed model using intraclass correlation will be used used to assess changes in participant weight pre and post intervention.
| pounds | African American Church Members |
|---|---|
| Goal Attainment as Measured by Weight in Pounds | 189 ± 44.5 |
A mixed model using intraclass correlation will be used to assess changes in participant fruit and vegetable intake pre and post intervention.
| Participants | African American Church Members |
|---|---|
| Goal Attainment as Measured by Number of Participants Consuming 7 or More Fruits and Vegetables Per Day | 6 |
A mixed model using intraclass correlation will be used to assess changes in physical activity at weeks 1 and 18 pre and post intervention.
| days | African American Church Members |
|---|---|
| Goal Attainment as Measured by Days Per Week That Participants Exercised for 30 Minutes or More | 4.5 ± 2.2 |
Collected over Baseline to 18 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| African American Church Members | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
| Age, Categorical(Participants) | African American Church Members |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 44 |
| >=65 years | 35 |
| Age, Continuous(years) | African American Church Members |
|---|---|
| Mean | 64 ± 11.8 |
| Sex: Female, Male(Participants) | African American Church Members |
|---|---|
| Female | 67 |
| Male | 13 |
| Race (NIH/OMB)(Participants) | African American Church Members |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 80 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | African American Church Members |
|---|---|
| United States | 80 |
| Body Mass Index (BMI)(kg/m^2) | African American Church Members |
|---|---|
| Mean | 32.9 ± 7.2 |
| Weight(pounds) | African American Church Members |
|---|---|
| Mean | 198 ± 51.2 |
| Fruit and Vegetable Intake(Participants) | African American Church Members |
|---|---|
| Count of participants | 1 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2019 to primary completion in Jul 2019, 6 months.
Results were first posted in Sep 2020, 1 year 1 month after primary completion.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 6 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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