Type 2 Diabetes
Conditions
Keywords
Immigrant, South Asian born Immigrant, African born Immigrant, Social Contact
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALIntensive 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Aim 1: * Men \>18 years of age * Diagnosis of Type 2 Diabetes (T2D) (documented A1c of ≥ 5.7% or fasting blood glucose of \>100) or prediabetes * A family member or peer is willing to participate and attend all sessions as a social partner (if enrolling in dyad arm) * Proficiency in English(if in dyad, at least one member of each dyad) * Willingness to provide written consent Inclusion Criteria for Aim 2: * Proficient in English * Age greater than or equal to 18 years
Exclusion criteria
Aim 1 and 2: * Type 1 diabetes or diabetes secondary to other conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced) * Malignancy or life-threatening illness with life expectancy of \<5 years * End-stage disease or serious illness that prohibits participation (e.g. end-stage renal disease or class IV congestive heart failure) * Inability to perform unsupervised physical activity * Diagnosed with cognitive deficits or limited decision-making capacity * Alcohol or substance abuse * Homelessness or no fixed address.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Group Preference | Baseline | 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. |
| Feasibility: Proportion of Subjects Who Enroll | Baseline | 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). |
| Retention: Number of Sessions Attended | From baseline to week 16 | 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. |
| Acceptability: Satisfaction Questionnaire | Month 6 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Body Weight | Baseline, month 6 | Participant's weight will be measured in kilograms using a calibrated, standardized scale. |
| Changes in Systolic Blood Pressure | Baseline, month 6 | 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. |
| Changes in Body Mass Index (BMI) | Baseline, month 6 | 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. |
| Changes in Diet | Baseline, month 6 | 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. |
| Change in Weight Control Strategies Scale (WCSS) Score for Social Contacts | Baseline and month 6 | 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. |
| Changes in Physical Activity | Baseline, month 6 | 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 |
| Changes in Abdominal Waist Circumference | Baseline, month 6 | Waist circumference will be measured in centimeters (cm) by the World Health Organization recommended method. |
| Changes in Diastolic Blood Pressure | Baseline, month 6 | 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. |
| Changes in Hemoglobin A1c | Baseline, month 6 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Participants Participants who co-participated in a 5-session lifestyle intervention for diabetes management and prevention | 54 |
| Support Group Support group comprised of participant's social partner. | 54 |
| Total | 108 |
Baseline characteristics
| Characteristic | Total | Participants |
|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 10.5 | 52.8 years STANDARD_DEVIATION 10.5 |
| Education High School Graduate | 5 Participants | 5 Participants |
| Education Some College | 5 Participants | 5 Participants |
| Education Some high school | 8 Participants | 8 Participants |
| Education unknown | 36 Participants | 36 Participants |
| Employment Status Employed for wages | 24 Participants | 24 Participants |
| Employment Status Homemaker | 11 Participants | 11 Participants |
| Employment Status Retired | 13 Participants | 13 Participants |
| Employment Status Self-employed | 1 Participants | 1 Participants |
| Employment Status Student | 1 Participants | 1 Participants |
| Employment Status Unemployed | 4 Participants | 4 Participants |
| English Fluency Good | 21 Participants | 21 Participants |
| English Fluency Not good | 16 Participants | 16 Participants |
| English Fluency Not good at all | 4 Participants | 4 Participants |
| English Fluency Very good | 13 Participants | 13 Participants |
| Language Spoken at Home Mix of English/ Native | 10 Participants | 10 Participants |
| Language Spoken at Home Mostly English | 0 Participants | 0 Participants |
| Language Spoken at Home Mostly Native | 43 Participants | 43 Participants |
| Language Spoken at Home Other | 1 Participants | 1 Participants |
| Marital Status Divorced | 1 Participants | 1 Participants |
| Marital Status Married | 45 Participants | 45 Participants |
| Marital Status unknown | 1 Participants | 1 Participants |
| Marital Status Widowed | 7 Participants | 7 Participants |
| Native Language Bengali | 53 Participants | 53 Participants |
| Native Language Other | 1 Participants | 1 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — |
| Sex: Female, Male Female | 28 Participants | 28 Participants |
| Sex: Female, Male Male | 26 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 54 |
| other Total, other adverse events | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 |
Outcome results
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.
Time frame: Month 6
Population: No data was collected from the support group for this Outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dyads | Acceptability: Satisfaction Questionnaire | 5 score on a scale | Standard Deviation 0 |
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).
Time frame: Baseline
Population: No data was collected on the support group for this outcome measure. 122 is the number of people who were approached for the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dyads | Feasibility: Proportion of Subjects Who Enroll | 54 participants enrolled |
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.
Time frame: Baseline
Population: No data was collected from the support group for this Outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dyads | Recruitment Group Preference | 54 participants |
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.
Time frame: From baseline to week 16
Population: The data collected for this outcome is only for the sessions attended together.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dyads | Retention: Number of Sessions Attended | 4.7 sessions | Standard Deviation 0.53 |
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.
Time frame: Baseline and 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.
Time frame: Baseline, 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.
Time frame: Baseline, month 6
Population: No data was collected from the support group for this Outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dyads | Changes in Body Mass Index (BMI) | Baseline | 26.56 kg/m2 | Standard Deviation 3.71 |
| Dyads | Changes in Body Mass Index (BMI) | Month 6 | 25.92 kg/m2 | Standard Deviation 4.94 |
Other Pre-specified
Changes in Body Weight
Participant's weight will be measured in kilograms using a calibrated, standardized scale.
Time frame: Baseline, month 6
Population: No data was collected from the support group for this Outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dyads | Changes in Body Weight | Baseline | 155.4 pounds | Standard Deviation 25.96 |
| Dyads | Changes in Body Weight | Month 6 | 152.8 pounds | Standard Deviation 25.6 |
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.
Time frame: Baseline, month 6
Population: No data was collected from the support group for this Outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dyads | Changes in Diastolic Blood Pressure | Baseline | 76.32 mm of HG | Standard Deviation 7.65 |
| Dyads | Changes in Diastolic Blood Pressure | Month 6 | 76.0 mm of HG | Standard Deviation 7.5 |
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.
Time frame: Baseline, month 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dyads | Changes in Diet | Baseline | 2.140 score on a scale | Standard Deviation 1.3 |
| Dyads | Changes in Diet | Month 6 | 2.05 score on a scale | Standard Deviation 1.31 |
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.
Time frame: Baseline, month 6
Population: No data was collected from the support group for this Outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dyads | Changes in Hemoglobin A1c | Baseline | 7.57 percentage of HbA1C | Standard Deviation 1.49 |
| Dyads | Changes in Hemoglobin A1c | Month 6 | 6.72 percentage of HbA1C | Standard Deviation 0.81 |
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
Time frame: Baseline, month 6
Population: No data was collected from the support group for this Outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dyads | Changes in Physical Activity | Baseline | 130.7 minutes/ week | Standard Deviation 187.8 |
| Dyads | Changes in Physical Activity | Month 6 | 245.5 minutes/ week | Standard Deviation 154.9 |
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.
Time frame: Baseline, month 6
Population: No data was collected from the support group for this Outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dyads | Changes in Systolic Blood Pressure | Baseline | 129.7 mm of Hg | Standard Deviation 19.4 |
| Dyads | Changes in Systolic Blood Pressure | Month 6 | 123.9 mm of Hg | Standard Deviation 13.95 |