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| ID | Type | Description | Link |
|---|---|---|---|
| 1P60MD006917 | 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 investigators plan to test two different strategies for weight loss and diabetes prevention in the Latino community in and around Forsyth County, North Carolina. The study is designed to test the hypothesis that a lifestyle weight-loss program implemented within the Latino community will have a more beneficial and clinically meaningful impact on hemoglobin A1c (HbA1c), insulin metabolism, and markers of the metabolic syndrome when compared to an enhanced usual care condition. This lifestyle intervention will include group-based sessions promoting healthy eating, increased physical activity and weight loss. These sessions will be delivered by lay community members, known as Latino Health Advisors (LHAs). The enhanced usual care group will consist of individual counseling with are registered dietitian and uses existing community resources to assist participants in making healthier lifestyle choices.
Type 2 diabetes mellitus is a major health concern in the United States, accounting for 90 to 95% of the more than 25 million diagnosed cases of diabetes in 2010. Racial and ethnic minorities are disproportionately affected by the diabetes epidemic, specifically African Americans, Latinos, and Native Americans. Although the cumulative evidence suggests that lifestyle interventions to prevent diabetes can be implemented across a variety of settings with diverse personnel, numerous barriers to widespread dissemination in minority populations still exist. Latinos Combatiendo la Diabetes (La Comunidad) is a 225-participant randomized trial designed to test the hypothesis that a community-based lifestyle weight-loss intervention implemented within the accountability and structure of existing Latino communities will have a more beneficial and clinically meaningful impact on HbA1c, insulin metabolism, and markers of the metabolic syndrome when compared to an enhanced usual care condition. An economic evaluation will also be conducted to determine costs and cost-effectiveness. One trial arm will consist of a group-based intensive lifestyle intervention promoting healthy eating, increased physical activity and modest, yet achievable (5-7%) weight loss delivered in an early 6-month intensive phase followed by an 18-month maintenance phase. Latino Health Advisors (LHAs) will be utilized in the intensive intervention arm. The control arm will consist of an individual educational intervention that incorporates existing community resources that are available to assist residents in making healthier lifestyle choices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Weight-Loss | Experimental | Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by Latino Health Advisors (LHAs). The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1. All participants will be seen for assessment visits as baseline, 6, and 12 months. Some participants will also complete 18 and 24 month visits, depending on the date of randomization. |
|
| Enhanced Usual Care | Active Comparator | Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources.All participants will be seen for assessment visits as baseline, 6, and 12 months. Some participants will also complete 18 and 24 month visits, depending on the date of randomization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Weight Loss | Behavioral | Changing diet, physical activity, and self-regulatory behaviors to promote weight loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed. | 6, 12, 18, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed. | 6, 12, 18, and 24 months |
| Systolic Blood Pressure | Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Insulin | Mean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed. | 6, 12, and 24 months |
| Homeostasis Model of Insulin Resistance (HOMA IR) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mara Z Vitolins, DrPH RDN | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
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Baseline and randomization visits began in January 2014 and concluded in June 2016. In a roughly 26-month period, 225 participants were randomized (150 lifestyle intervention; 75 enhanced usual care) to take part in La Comunidad.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Weight-Loss | Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by Latino Health Advisors (LHAs). The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1. Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss. |
| FG001 | Enhanced Usual Care | Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources. Counseling: Individual nutrition counseling will be delivered by a registered dietitian. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Weight-Loss | Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by Latino Health Advisors (LHAs). The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with a registered dietitian during months 1, 3, and 6 of phase 1. Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss. |
| 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 | Hemoglobin A1c | Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed. | Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected. | Posted | Mean | Standard Deviation | percent HbA1c | 6, 12, 18, and 24 months |
|
Information on adverse events and serious adverse events was collected every 6 months for up to 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 | Lifestyle Weight-Loss | Participants in the Behavioral: Lifestyle Weight Loss arm will take part in a group program aimed at achieving modest weight loss (5-7%) through promoting healthy eating and increasing physical activity. The intervention sessions will take place at churches and other community locations and will be coordinated and facilitated by LHAs. The lifestyle intervention will be delivered in 2 phases: Phase 1 will last for 6 months and consist of weekly group meetings; Phase 2 will last for 18 months and consist of one LHA-led group session or one telephone contact from the LHA per month. Participants in this treatment arm will also receive individual visits with an RD during months 1, 3, and 6 of phase 1. Lifestyle Weight Loss: Changing diet, physical activity, and self-regulatory behaviors to promote weight loss. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death from non-study related causes (colon cancer) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Participant was diagnosed with late-stage colon cancer during study and died as a result of cancer progression. This event was reviewed by the study safety officer and deemed unrelated to participation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint/Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pain, injury, or discomfort in knee, shoulder, or other joints. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mara Z. Vitolins, DrPH, MPH, RDN | Wake Forest School of Medicine | (336) 716-2886 | mvitolin@wakehealth.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 15, 2017 | Jul 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Counseling | Behavioral | Individual nutrition counseling will be delivered by a registered dietitian. |
|
| 6, 12, 18, and 24 months |
| Diastolic Blood Pressure | Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed. | 6, 12, 18, and 24 months |
| Fasting Glucose | Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed. | 6, 12, 18, and 24 months |
| Total Cholesterol | Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed. | 12, and 24 months |
| High Density Lipoprotein (HDL) | Mean HDL in both treatment groups at 12 and 24 months will be assessed. | 12, and 24 months |
| Low Density Lipoprotein (LDL) | Mean LDL in both treatment groups at 12 and 24 months will be calculated. | 12, and 24 months |
| Triglycerides | Mean triglycerides in both treatment groups at 12 and 24 months will be calculated. | 12, and 24 months |
Mean change in the HOMA IR model from baseline between treatment groups at 6, 12, and 24 months will be assessed.
| 6, 12, and 24 months |
| BG001 | Enhanced Usual Care | Participants in the Behavioral: Counseling arm will receive two individual sessions with registered dietitian and monthly newsletters that focus on existing community resources. Counseling: Individual nutrition counseling will be delivered by a registered dietitian. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hemoglobin A1c | Mean | Standard Deviation | percent |
|
| Body Weight | Mean | Standard Deviation | kilograms |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Fasting Glucose | Mean | Standard Deviation | mg/dL |
|
| High Density Lipoprotien (HDL) | Mean | Standard Deviation | mg/dL |
|
| Low Density Lipoprotein (LDL) | Mean | Standard Deviation | mg/dL |
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| Triglycerides | Mean | Standard Deviation | mg/dL |
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| Total Cholesterol | Mean | Standard Deviation | mg/dL |
|
| OG001 | Enhanced Usual Care | Participants in the Behavioral: Counseling arm will receive two individual sessions with a registered dietitian and monthly newsletters that focus on existing community resources. Counseling: Individual nutrition counseling will be delivered by a registered dietitian. |
|
|
| Secondary | Body Weight | Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed. | Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected. | Posted | Mean | Standard Deviation | kilograms | 6, 12, 18, and 24 months |
|
|
|
| Secondary | Systolic Blood Pressure | Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed. | Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected. | Posted | Mean | Standard Deviation | mmHg | 6, 12, 18, and 24 months |
|
|
|
| Secondary | Diastolic Blood Pressure | Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed. | Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected. | Posted | Mean | Standard Deviation | mmHg | 6, 12, 18, and 24 months |
|
|
|
| Secondary | Fasting Glucose | Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed. | Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected. | Posted | Mean | Standard Deviation | mg/dL | 6, 12, 18, and 24 months |
|
|
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| Secondary | Total Cholesterol | Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed. | Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected. | Posted | Mean | Standard Deviation | mg/dL | 12, and 24 months |
|
|
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| Secondary | High Density Lipoprotein (HDL) | Mean HDL in both treatment groups at 12 and 24 months will be assessed. | Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected. | Posted | Mean | Standard Deviation | mg/dL | 12, and 24 months |
|
|
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| Secondary | Low Density Lipoprotein (LDL) | Mean LDL in both treatment groups at 12 and 24 months will be calculated. | Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected. | Posted | Mean | Standard Deviation | mg/dL | 12, and 24 months |
|
|
|
| Secondary | Triglycerides | Mean triglycerides in both treatment groups at 12 and 24 months will be calculated. | Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected. | Posted | Mean | Standard Deviation | mg/dL | 12, and 24 months |
|
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| Other Pre-specified | Fasting Insulin | Mean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed. | Not Posted | 6, 12, and 24 months | Participants |
| Other Pre-specified | Homeostasis Model of Insulin Resistance (HOMA IR) | Mean change in the HOMA IR model from baseline between treatment groups at 6, 12, and 24 months will be assessed. | Not Posted | 6, 12, and 24 months | Participants |
| 2 |
| 150 |
| 4 |
| 150 |
| 13 |
| 150 |
| EG001 | Enhanced Usual Care | Participants in the Behavioral: Counseling arm will receive two individual sessions with an RD and monthly newsletters that focus on existing community resources. Counseling: Individual nutrition counseling will be delivered by a registered dietitian. | 0 | 75 | 1 | 75 | 10 | 75 |
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| death from non-study related causes (aneurysm) | Vascular disorders | Systematic Assessment | Participant suffered a ruptured aneurysm while driving and died. This event was reviewed by the study safety officer and deemed unrelated to participation. |
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| Inpatient hospitalization for surgery | Surgical and medical procedures | Systematic Assessment | 3 participants were hospitalized overnight for medical procedures unrelated to study participation. |
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D001836 | Body Weight Changes |
| D005159 | Health Care Facilities Workforce and Services |
| 12 Months |
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| 24 Months |
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| 24 Months |
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| 24 Months |
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