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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017342-01 | 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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The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast, Minnesota.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Community-Based Mentoring and Education Sessions | Experimental | Subjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment. |
|
| Delayed Community-Based Mentoring and Education Sessions | Experimental | Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-based mentoring and education sessions | Behavioral | Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Difference in weight (measured in kilograms) from baseline to 6 months and from baseline to 12 months | Baseline, 6 months, 12 months |
| Change in Waist Circumference From Baseline to 6 Months and From Baseline to 12 Months | Measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest. | Baseline, 6 months, 12 months |
| Change in "Life's Simple 6" Composite Score From Baseline to 6 Months and From Baseline to 12 Months | Adapted from the American Heart Association standards based on health assessment data. Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-12 points). | Baseline, 6 months, 12 months |
| Lost >5% of Body Weight | Number of participants in each arm who lost a clinically significant amount of weight (>5%). | 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure | Measured three times and the average of the second and third readings will be used in analyses, reported in mmHg. Change from baseline to 6 months and from baseline to 12 months. | Baseline, 6 months, 12 months |
| Change in Fasting Glucose Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Wieland, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41379348 | Derived | Tranby B, Sia I, Clark M, Novotny P, Lohr A, Suarez Pardo L, Patten C, Iteghete S, Zeratsky K, Rieck T, Molina L, Porraz Capetillo G, Ahmed Y, Dirie H, Wieland M. Self-Efficacy Is Associated with Health Behaviors Related To Obesity and Cardiovascular Risk Among Hispanic/Latinx and Somali Immigrants To the United States. J Immigr Minor Health. 2026 Jun;28(3):603-611. doi: 10.1007/s10903-025-01812-9. Epub 2025 Dec 11. | |
| 40034444 | Derived |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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The units of randomization were social networks defined by a Health Promoter and their network members. Randomization occurred after all participants were enrolled and baseline measures completed. Constrained randomization was used with the assignment selected from a set of allocations balanced on ethnicity, age, network size, and sex of the HPs.
The period titles are referring to the time after starting intervention.
The social networks (units of randomization) were defined as the Health Promoter (HP) and their friend/family social network members. At 0-5 months, this included 29 Hispanic and 22 Somali social networks. At 6-11 months, this included 23 Hispanic and 22 Somali social networks. At 12-24 months, this included 23 Hispanic and 22 Somali social networks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Community-Based Mentoring and Education Sessions | Subjects received the intervention of community-based mentoring and education sessions immediately after enrollment. In the first 6 months (months 0-5) health promoters facilitated 12 face-to-face or virtual group visits. Each visit targeted a specific health promotion behavior for weight loss and/or reduction of cardiovascular risk. Each group session included goal setting, review of food and/or activity tracking, and positive reflections. Strategies for weight loss included regular weigh-ins, completion of food and physical activity records, reducing portion sizes, planning meals, use of MyPlate for dietary proportions, removing problem foods from the home, increasing physical activity level, and reducing sedentary behavior. HPs supported and monitored progress of their group via six evidence-based strategies: tracking, goal setting, mindfulness, social support, problem solving, and motivation. Over the subsequent 6 months (months 6-11), health promoters facilitated an additional 12 virtual or face-to-face weight maintenance sessions to focus on goal setting, social support, motivation for lifestyle changes, review of food and/or activity tracking, and reflections. No new education material was provided. |
| FG001 | Delayed Community-Based Mentoring and Education Sessions | Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment. In the first 6 months (months 12-17 from baseline) health promoters facilitated 12 face-to-face or virtual group visits. Each visit targeted a specific health promotion behavior for weight loss and/or reduction of cardiovascular risk. Each group session included goal setting, review of food and/or activity tracking, and positive reflections. Strategies for weight loss included regular weigh-ins, completion of food and physical activity records, reducing portion sizes, planning meals, use of MyPlate for dietary proportions, removing problem foods from the home, increasing physical activity level, and reducing sedentary behavior. HPs supported and monitored progress of their group via six evidence-based strategies: tracking, goal setting, mindfulness, social support, problem solving, and motivation. Over the subsequent 6 months (months 18-24 from baseline), health promoters facilitated an additional 12 virtual or face-to-face weight maintenance sessions to focus on goal setting, social support, motivation for lifestyle changes, review of food and/or activity tracking, and reflections. No new education material was provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0-5 Months |
| |||||||||||||||||||||||||
| 6-11 Months |
| |||||||||||||||||||||||||
| 12-24 Months |
|
The health promoters are enrolled participants and included in the baseline characteristic data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Community-Based Mentoring and Education Sessions | Subjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment. Community-based mentoring and education sessions: Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Weight | Difference in weight (measured in kilograms) from baseline to 6 months and from baseline to 12 months | The health promoters are enrolled participants and included in this outcome measure. | Posted | Mean | Standard Deviation | Kilograms | Baseline, 6 months, 12 months |
|
24 months
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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 | Immediate Community-Based Mentoring and Education Sessions | Subjects will receive the intervention of community-based mentoring and education sessions immediately after enrollment. Community-based mentoring and education sessions: Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Wieland | Mayo Clinic | 507-250-5993 | wieland.mark@mayo.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 | Sep 28, 2022 | Aug 26, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2021 | Nov 3, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
6 hours fasting glucose blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months. |
| Baseline, 6 months, 12 months |
| Change in Low-density Lipoprotein (LDL) | Change in LDL cholesterol blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months | Baseline, 6 months, 12 months |
| Change in Dietary Quality | 24-hour dietary recall collected using the Nutrition Data System for Research (NDSR) used to calculate the Healthy Eating index (HEI-2015). The HEI range is 0-100 with higher scores indicating healthier dietary quality. Scores can be further categorized as HEI≥69.3 optimal, HEI 56.9-69.2 intermediate, HEI<56.9 poor. Change from baseline to 6 months and baseline to 12 months. | Baseline, 6 months, 12 months |
| Change in Physical Activity | Measured using the International Physical Activity Questionnaire (IPAQ) that assesses the number of minutes of mild, moderate, and vigorous physical activity over the previous 7 days, scores categorized as ≥150 min/wk moderate or ≥75 min/wk vigorous or ≥150 min/wk moderate+vigorous = optimal; 1-149 min/wk moderate or 1-74 min/wk vigorous or 1-149 min/wk moderate+vigorous = intermediate; no physical activity = poor. Baseline to 6 months and baseline to 12 months. For this study, we present IPAQ results as a continuous variable of MET minutes per week, which refers to the total amount of physical activity measured in Metabolic Equivalent of Task (MET) units over a week. Physical Activity Guidelines recommend achieving 500 to 1,000 MET minutes per week for significant health benefits. | Baseline, 6 months, 12 months |
| Change in Diastolic Blood Pressure | Chage from baseline to 6 months and from baseline to 12 months (mmHg) | Baseline, 6 months, 12 months |
| Tranby B, Sia I, Clark M, Novotny P, Lohr A, Pardo LS, Patten C, Iteghete S, Zeratsky K, Rieck T, Molina L, Capetillo GP, Ahmed Y, Dirie H, Wieland M. Self-Efficacy is Associated with Health Behaviors Related to Obesity and Cardiovascular Risk among Hispanic/Latinx and Somali Immigrants to the United States. Res Sq [Preprint]. 2025 Feb 19:rs.3.rs-6001516. doi: 10.21203/rs.3.rs-6001516/v1. |
| 39014369 | Derived | Tranby BN, Sia IG, Clark MM, Novotny PJ, Lohr AM, Pardo LS, Patten CA, Iteghete SO, Zeratsky KA, Rieck TM, Molina L, Capetillo GP, Ahmed Y, Dirie H, Wieland ML. Negative mood is associated with sociobehavioral factors contributing to cardiovascular risk in an immigrant population. BMC Public Health. 2024 Jul 16;24(1):1911. doi: 10.1186/s12889-024-19402-z. |
| 38578534 | Derived | Lohr AM, Pratt R, Dirie H, Ahmed Y, Elmi H, Nur O, Osman A, Novotny P, Mohamed AA, Griffin JM, Sia IG, Wieland ML. The Association Between Perceived Discrimination, Age and Proportion of Lifetime in the United States Among Somali Immigrants: A Cross-Sectional Analysis. J Immigr Minor Health. 2024 Aug;26(4):689-698. doi: 10.1007/s10903-024-01589-3. Epub 2024 Jul 18. |
| 38559259 | Derived | Tranby BN, Sia IG, Clark MM, Novotny PJ, Lohr AM, Pardo LS, Patten CA, Iteghete SO, Zeratsky KA, Rieck TM, Molina L, Capetillo GP, Ahmed Y, Drie H, Wieland ML. Negative Mood is Associated with Sociobehavioral Factors Contributing to Cardiovascular Risk in an Immigrant Population. Res Sq [Preprint]. 2024 Mar 12:rs.3.rs-3934645. doi: 10.21203/rs.3.rs-3934645/v1. |
| Somali HP |
|
| Hispanic Participants |
|
| Somali Participants |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Somali HP |
|
| Hispanic Participants |
|
| Somali Participants |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Delayed Community-Based Mentoring and Education Sessions | Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment. Community-based mentoring and education sessions: Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Life's Simple 6 Composite | Mean | Standard Deviation | units on a scale |
|
| Waist Circumference | Mean | Standard Deviation | Centimeters |
|
| Delayed Community-Based Mentoring and Education Sessions |
Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment. Community-based mentoring and education sessions: Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks. |
|
|
| Primary | Change in Waist Circumference From Baseline to 6 Months and From Baseline to 12 Months | Measured to the nearest 0.1 cm at the narrowest part of the torso between the ribs and the iliac crest. | The health promoters are enrolled participants and included in this outcome measure. | Posted | Mean | Standard Deviation | Centimeters | Baseline, 6 months, 12 months |
|
|
|
| Primary | Change in "Life's Simple 6" Composite Score From Baseline to 6 Months and From Baseline to 12 Months | Adapted from the American Heart Association standards based on health assessment data. Point values are assigned to each component: 2 points for ideal, 1 point for intermediate, 0 points for poor. The total sum allows for a continuous measure of cardiovascular health ranging from poor to ideal (0-12 points). | The health promoters are enrolled participants and included in this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months, 12 months |
|
|
|
| Primary | Lost >5% of Body Weight | Number of participants in each arm who lost a clinically significant amount of weight (>5%). | The health promoters are enrolled participants and included in this outcome measure. | Posted | Count of Participants | Participants | 6 months, 12 months |
|
|
|
| Secondary | Change in Systolic Blood Pressure | Measured three times and the average of the second and third readings will be used in analyses, reported in mmHg. Change from baseline to 6 months and from baseline to 12 months. | The health promoters are enrolled participants and included in this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Change in Fasting Glucose Level | 6 hours fasting glucose blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months. | The health promoters are enrolled participants and included in this outcome measure. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Change in Low-density Lipoprotein (LDL) | Change in LDL cholesterol blood serum level, reported in mg/dL. Baseline to 6 months and baseline to 12 months | The health promoters are enrolled participants and included in this outcome measure. | Posted | Mean | Standard Deviation | mg/Dl | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Change in Dietary Quality | 24-hour dietary recall collected using the Nutrition Data System for Research (NDSR) used to calculate the Healthy Eating index (HEI-2015). The HEI range is 0-100 with higher scores indicating healthier dietary quality. Scores can be further categorized as HEI≥69.3 optimal, HEI 56.9-69.2 intermediate, HEI<56.9 poor. Change from baseline to 6 months and baseline to 12 months. | The health promoters are enrolled participants and included in this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Change in Physical Activity | Measured using the International Physical Activity Questionnaire (IPAQ) that assesses the number of minutes of mild, moderate, and vigorous physical activity over the previous 7 days, scores categorized as ≥150 min/wk moderate or ≥75 min/wk vigorous or ≥150 min/wk moderate+vigorous = optimal; 1-149 min/wk moderate or 1-74 min/wk vigorous or 1-149 min/wk moderate+vigorous = intermediate; no physical activity = poor. Baseline to 6 months and baseline to 12 months. For this study, we present IPAQ results as a continuous variable of MET minutes per week, which refers to the total amount of physical activity measured in Metabolic Equivalent of Task (MET) units over a week. Physical Activity Guidelines recommend achieving 500 to 1,000 MET minutes per week for significant health benefits. | The health promoters are enrolled participants and included in this outcome measure. | Posted | Mean | Standard Deviation | MET minutes per week | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Change in Diastolic Blood Pressure | Chage from baseline to 6 months and from baseline to 12 months (mmHg) | The health promoters are enrolled participants and included in this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, 6 months, 12 months |
|
|
|
| 0 |
| 246 |
| 0 |
| 246 |
| 0 |
| 246 |
| EG001 | Delayed Community-Based Mentoring and Education Sessions | Subjects will receive the intervention of community-based mentoring and education sessions approximately 12 months after enrollment. Community-based mentoring and education sessions: Community-based mentoring and education sessions, group activities, and application of a community toolkit for healthy weight loss delivered by trained Health Promoters from Hispanic and Somali communities to their social networks. | 0 | 229 | 0 | 229 | 0 | 229 |
Not provided
Not provided