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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23MD015088-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This study (Aim 1) seeks to test that a culturally-tailored lifestyle intervention is feasible and acceptable for immigrant men from South Asia and West Africa. This will be a pre-post pilot study of a 16-week lifestyle program for South Asians and West Africans with prediabetes or diabetes in Atlanta. Patients will participate in health-professional-led group visits every other week focused on improving dietary and exercise practices to reduce weight. Groups will be followed at baseline, 4 months and 12 months. Groups will be separated by region of origin (i.e. separate groups for South Asians and West Africans). For Aim 2,the study team will assess intervention spillover effects among participant's self-identified social networks. The study team will ask participants in Aim 1 to name 5 people in their social networks to participate in a survey of health behaviors at baseline and 12-months to assess health behavior practices.
South Asians and Africans are growing immigrant groups at high risk for diabetes in the US. South Asian (SA) (ancestry originating from India, Pakistan, Bangladesh and other parts of South Asia) and Sub-Saharan African immigrant groups make up two of the fastest growing immigrant groups in the US. SAs have higher rates of T2D and cardiovascular disease than whites. Furthermore, SAs without diabetes have a high prevalence of T2D risk factors.
Sub-Saharan African-born immigrants (the proposed study will focus on West African (WA) countries: those originating from Benin, Burkina Faso, Cape Verde, The Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Liberia, Mali, Mauritania, Niger, Nigeria, Senegal, Sierra Leone, and Togo), whose population in the US has doubled every decade since 1980, are also at high risk for T2D. Dietary patterns of African immigrants are high in carbohydrates and animal protein, compared to African populations who did not immigrate.
These findings in SA and African immigrant communities challenge the well-accepted "healthy immigrant effect" phenomenon (that immigrants are on average healthier than native-born persons), suggesting that more tailored T2D prevention and management strategies are greatly needed to narrow the disparities in outcomes between these and other US populations. Previous trials showed that intensive lifestyle interventions (ILIs), group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease T2D incidence in people with prediabetes and reduced complications among people with T2D. Additional analyses have shown that the effects of lifestyle interventions are long-lasting, even when participants gain back some of the weight lost during the program.
Family and social networks could be an important factor to improve patient activation, especially for South Asian and African immigrant men. Social networks, defined as someone with social or family ties to an individual, affect health through myriad mechanisms including social support, social influence, social engagement, and access to resources. This study aims to focus on SA and WA immigrant men as model populations to examine preferences, feasibility, and acceptability for a shared medical appointment (SMA) intervention based in primary care and developed with user-driven input and changes in healthy lifestyle practices among participants' social networks. This will be a pre-post pilot study of a 16-week lifestyle program for the mentioned immigrant groups with prediabetes or diabetes in Atlanta. Patients will participate in health-professional-led group visits every other week focused on improving dietary and exercise practices to reduce weight. Groups will be followed at baseline, 4 months and 12 months. For Aim 2, the study team will assess intervention spillover effects among participant's self-identified social networks. The study team will ask participants in Aim 1 to name 5 people in their social networks to participate in a survey of health behaviors at baseline and 12-months to assess health behavior practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyads | Experimental | This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions. |
|
| Men Only | Active Comparator | This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive lifestyle interventions (ILIs) | Behavioral | Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Group Preference | Which group of the study are participants choosing between the single participant group or the dyad. Preferences will be assessed by quantifying number enrolled in each group. | Baseline |
| Feasibility: Proportion of Subjects Who Enroll | The proportion of adults who are contacted and informed about the study and who enroll during study baseline. Feasibility will be assessed by quantifying rate of enrollment, number of sessions attended by participants (for dyad arm, will assess participant and social contact, individually and together). | Baseline |
| Retention: Number of Sessions Attended | Number of sessions attended; for dyads, this would include sessions attended together and separately, over the 16-week study period. There were 5 sessions total. | From baseline to week 16 |
| Acceptability: Satisfaction Questionnaire | Questionnaires assessed participant perceptions of ILI after the program to evaluate satisfaction with the program and suggestions for program improvement. Acceptability will be assessed by quantifying Likert-like scales of satisfaction of overall intervention. This is a 0 to 5 scale, where "0" represents the least level of satisfaction and "5" represents the highest level of satisfaction. | Month 6 |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Mass Index (BMI) | Participant's weight will be measured in kilograms using a calibrated, standardized scale, and height will be measured in meters (m), using a standardized stadiometer. BMI will be calculated using the standard formula of kg/m^2. | Baseline, month 6 |
| Changes in Abdominal Waist Circumference |
Inclusion Criteria for Aim 1:
Inclusion Criteria for Aim 2:
Exclusion Criteria Aim 1 and 2:
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| Name | Affiliation | Role |
|---|---|---|
| Megha Shah, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Family Medicine Center | Dunwoody | Georgia | 30338 | United States |
Any de-identified data, upon request
Data will be available 6 months after data collection is complete
De-identified Data will be available to any party who completes a data use agreement that describes for what purpose the data will be used with a clear analysis plan.
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Participants were recruited from Emory Family Medicine Center. Participant enrollment began on April 4, 2022, and all follow-up assessments were completed by January 1, 2024 The study was a quasi-experimental design to understand preferences in this community. The PI offered a men-only group with very little interest in this group thus this arm was never carried forward. No subjects were enrolled in this group. Men-only group was not supposed to be a comparator arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dyads | This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. The intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this dyad-based group, participant's social partner must commit to attend all in-person sessions. Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No baseline characteristics data was collected on the support group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Participants who co-participated in a 5-session lifestyle intervention for diabetes management and prevention |
| BG001 | Support Group | Support group comprised of participant's social partner. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | No baseline characteristics were collected from support group |
| 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 | Recruitment Group Preference | Which group of the study are participants choosing between the single participant group or the dyad. Preferences will be assessed by quantifying number enrolled in each group. | No data was collected from the support group for this Outcome measure. | Posted | Number | participants | Baseline |
|
From baseline to post-intervention (Month 6)
No data was collected from the support group. Adverse event data was collected only on the participants.
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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 | Participants | Participants who co-participated in a 5-session lifestyle intervention for diabetes management and prevention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Megha K. Shah | Emory University | 404-778-6944 | mkshah@emory.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 | Feb 5, 2025 | Feb 9, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2021 | Feb 1, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Waist circumference will be measured in centimeters (cm) by the World Health Organization recommended method. |
| Baseline, month 6 |
| Changes in Diastolic Blood Pressure | Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. | Baseline, month 6 |
| Changes in Hemoglobin A1c | Participant's Hemoglobin A1c (HbA1c) will be measured with a point-of-care testing (POCT) well-validated clinical instrument. Normal values for HbA1c are below 5.7% while values of 6.5% and above indicate diabetes. | Baseline, month 6 |
| Changes in Body Weight | Participant's weight will be measured in kilograms using a calibrated, standardized scale. | Baseline, month 6 |
| Changes in Systolic Blood Pressure | Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. | Baseline, month 6 |
| Changes in Physical Activity | Participants will be asked to keep a daily activity log (minutes of exercise performed daily will be logged). All logged exercises will be considered physical activity. The study coordinators will measure the amount in hours of exercise performed and compare each participant's log at the different time points to asses in that subject's physical activity | Baseline, month 6 |
| Changes in Diet | Changes in diet will be measured using the Rapid Eating and Activity Assessment for Participants short version (REAP-S). The REAP-S consists of 13 scored questions. Responses of 'usually/often' receive 1 point, 'sometimes' receives 2 points, and 'rarely/never or does not apply to me' receives 3 points. Possible scores ranged from 13 to 39 with a higher score indicating a higher diet quality. | Baseline, month 6 |
| Change in Weight Control Strategies Scale (WCSS) Score for Social Contacts | Participants' social contacts will complete the WCSS. The WCSS is a 30-item questionnaire asking about weight control practices. Responses are given on a 5-point scale when 0 = never and 4 = always. A total score is calculated by taking the average of responses and ranges from 0 to 4 where higher scores indicate greater use of strategies to lose or maintain weight. | Baseline and month 6 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The initial plan was to recruit Males only, but due to recruiting challenges faced during COVID, the PI included Women in the study as well. | No baseline characteristics were collected on this group | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Native Language | No baseline characteristics were collected on this group | Count of Participants | Participants |
|
| English Fluency | No baseline characteristics were collected on this group | Count of Participants | Participants |
|
| Language Spoken at Home | No baseline characteristics were collected from support group | Count of Participants | Participants |
|
| Education | No baseline characteristics were collected from support group | Count of Participants | Participants |
|
| Employment Status | No baseline characteristics were collected from support group | Count of Participants | Participants |
|
| Marital Status | No baseline characteristics were collected from support group | No baseline characteristics were collected from support group | Count of Participants | Participants |
|
| OG001 | Men Only | This is a pragmatic, pre-post, pilot study. Participants will meet in groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine Center in Dunwoody, Georgia. the intervention will consist of bi-weekly sessions over a 16-week period, with phone check-ins for the remaining weeks. Each session will last 60-90 minutes, and participants will engage in a total of 6 televisit sessions. Sessions will consist of a group-based program for all participants, followed by a personalized care plan, led by a physician. In this group just the participant will receive the intervention. Intensive lifestyle interventions (ILIs): Intensive lifestyle interventions (ILIs) is a group-based programs designed to promote weight loss through a combination of diet, activity, and behavior change, decrease Type 2 Diabetes (T2D) incidence in people with prediabetes and reduced complications among people with T2D. |
|
|
| Primary | Feasibility: Proportion of Subjects Who Enroll | The proportion of adults who are contacted and informed about the study and who enroll during study baseline. Feasibility will be assessed by quantifying rate of enrollment, number of sessions attended by participants (for dyad arm, will assess participant and social contact, individually and together). | No data was collected on the support group for this outcome measure. 122 is the number of people who were approached for the study. | Posted | Number | participants enrolled | Baseline |
|
|
|
| Primary | Retention: Number of Sessions Attended | Number of sessions attended; for dyads, this would include sessions attended together and separately, over the 16-week study period. There were 5 sessions total. | The data collected for this outcome is only for the sessions attended together. | Posted | Mean | Standard Deviation | sessions | From baseline to week 16 |
|
|
|
| Primary | Acceptability: Satisfaction Questionnaire | Questionnaires assessed participant perceptions of ILI after the program to evaluate satisfaction with the program and suggestions for program improvement. Acceptability will be assessed by quantifying Likert-like scales of satisfaction of overall intervention. This is a 0 to 5 scale, where "0" represents the least level of satisfaction and "5" represents the highest level of satisfaction. | No data was collected from the support group for this Outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
|
|
|
| Other Pre-specified | Changes in Body Mass Index (BMI) | Participant's weight will be measured in kilograms using a calibrated, standardized scale, and height will be measured in meters (m), using a standardized stadiometer. BMI will be calculated using the standard formula of kg/m^2. | No data was collected from the support group for this Outcome measure. | Posted | Mean | Standard Deviation | kg/m2 | Baseline, month 6 |
|
|
|
| Other Pre-specified | Changes in Abdominal Waist Circumference | Waist circumference will be measured in centimeters (cm) by the World Health Organization recommended method. | Not Posted | Baseline, month 6 | Participants |
| Other Pre-specified | Changes in Diastolic Blood Pressure | Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. | No data was collected from the support group for this Outcome measure. | Posted | Mean | Standard Deviation | mm of HG | Baseline, month 6 |
|
|
|
| Other Pre-specified | Changes in Hemoglobin A1c | Participant's Hemoglobin A1c (HbA1c) will be measured with a point-of-care testing (POCT) well-validated clinical instrument. Normal values for HbA1c are below 5.7% while values of 6.5% and above indicate diabetes. | No data was collected from the support group for this Outcome measure. | Posted | Mean | Standard Deviation | percentage of HbA1C | Baseline, month 6 |
|
|
|
| Other Pre-specified | Changes in Body Weight | Participant's weight will be measured in kilograms using a calibrated, standardized scale. | No data was collected from the support group for this Outcome measure. | Posted | Mean | Standard Deviation | pounds | Baseline, month 6 |
|
|
|
| Other Pre-specified | Changes in Systolic Blood Pressure | Participant's systolic and diastolic blood pressure will be measured using standard procedures with a manual cuff. Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. | No data was collected from the support group for this Outcome measure. | Posted | Mean | Standard Deviation | mm of Hg | Baseline, month 6 |
|
|
|
| Other Pre-specified | Changes in Physical Activity | Participants will be asked to keep a daily activity log (minutes of exercise performed daily will be logged). All logged exercises will be considered physical activity. The study coordinators will measure the amount in hours of exercise performed and compare each participant's log at the different time points to asses in that subject's physical activity | No data was collected from the support group for this Outcome measure. | Posted | Mean | Standard Deviation | minutes/ week | Baseline, month 6 |
|
|
|
| Other Pre-specified | Changes in Diet | Changes in diet will be measured using the Rapid Eating and Activity Assessment for Participants short version (REAP-S). The REAP-S consists of 13 scored questions. Responses of 'usually/often' receive 1 point, 'sometimes' receives 2 points, and 'rarely/never or does not apply to me' receives 3 points. Possible scores ranged from 13 to 39 with a higher score indicating a higher diet quality. | The average was collected by analyzing the points scored on each item (points rated 1-3). No data was collected from the support group for this Outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline, month 6 |
|
|
|
| Other Pre-specified | Change in Weight Control Strategies Scale (WCSS) Score for Social Contacts | Participants' social contacts will complete the WCSS. The WCSS is a 30-item questionnaire asking about weight control practices. Responses are given on a 5-point scale when 0 = never and 4 = always. A total score is calculated by taking the average of responses and ranges from 0 to 4 where higher scores indicate greater use of strategies to lose or maintain weight. | Not Posted | Baseline and month 6 | Participants |
| 0 |
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
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| D004700 | Endocrine System Diseases |