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| ID | Type | Description | Link |
|---|---|---|---|
| 1F31NR017813-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| African American church members | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Support Dyad Intervention | Behavioral | 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 | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Goal Attainment as Measured by BMI (Body Mass Index) | Mixed models will be used to assess changes in participant BMI pre and post intervention. | Week 18 |
| Goal Attainment as Measured by Weight in Pounds |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Isaac Lipkus | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faithful Families Program | Raleigh | North Carolina | 27695 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed Phase I (>50% attendance). | Posted | Count of Participants | Participants | Baseline to week 18 |
|
Baseline to 18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cherie Conley | Duke School of Nursing | 2166597128 | cherie.conley@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2020 | Jul 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D002318 | Cardiovascular Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
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|
A mixed model using intraclass correlation will be used used to assess changes in participant weight pre and post intervention.
| 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. | 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. | Week 18 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Fruit and Vegetable Intake | Number of participants consuming 7 or more fruits and vegetables per day. | Count of Participants | Participants |
|
| Days of Physical Activity | Mean | Standard Deviation | days |
|
|
|
|
| Primary | 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) | Participants who completed the study. | Posted | Count of Participants | Participants | Measured at Week 18 |
|
|
|
|
| Primary | Health Educators' Perceptions of Feasibility as Measured by Semi-structured Interviews | Reported as number of health educators who found the program to be feasible. | Health educators who were interviewed. | Posted | Count of Participants | Participants | Measured at Week 18 |
|
|
|
| Secondary | Goal Attainment as Measured by BMI (Body Mass Index) | Mixed models will be used to assess changes in participant BMI pre and post intervention. | Participants who completed the study. | Posted | Mean | Standard Deviation | kg/m^2 | Week 18 |
|
|
|
|
| Secondary | 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. | Participants who completed the study. | Posted | Mean | Standard Deviation | pounds | Week 18 |
|
|
|
|
| Secondary | 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. | Participants who completed the study. | Posted | Count of Participants | Participants | Week 18 |
|
|
|
|
| Secondary | 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. | Participants who completed the study. | Posted | Mean | Standard Deviation | days | Week 18 |
|
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
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| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |