La Comunidad: Latinos Combating Diabetes

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01831921
• Collaborator: National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
• Enrollment: 225
• Location: 1
• Arms: 2
• Actual Duration (Months): 41.9
• Patients Per Site Per Month: 5.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pre Diabetes; Obesity; Metabolic Syndrome	Behavioral: Lifestyle Weight Loss; Behavioral: Counseling	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Jun 30, 2017
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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. 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.	Behavioral: Lifestyle Weight Loss; Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
Active Comparator: 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.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.	Behavioral: Counseling; Individual nutrition counseling will be delivered by a registered dietitian.

Outcome Measures

Primary Outcome Measures

1. Hemoglobin A1c [6, 12, 18, and 24 months]

   Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed.

Secondary Outcome Measures

1. Body Weight [6, 12, 18, and 24 months]

   Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.

2. Systolic Blood Pressure [6, 12, 18, and 24 months]

   Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.

3. Diastolic Blood Pressure [6, 12, 18, and 24 months]

   Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.

4. Fasting Glucose [6, 12, 18, and 24 months]

   Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.

5. Total Cholesterol [12, and 24 months]

   Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.

6. High Density Lipoprotein (HDL) [12, and 24 months]

   Mean HDL in both treatment groups at 12 and 24 months will be assessed.

7. Low Density Lipoprotein (LDL) [12, and 24 months]

   Mean LDL in both treatment groups at 12 and 24 months will be calculated.

8. Triglycerides [12, and 24 months]

   Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.

Other Outcome Measures

1. Fasting Insulin [6, 12, and 24 months]

   Mean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed.

2. Homeostasis Model of Insulin Resistance (HOMA IR) [6, 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men and women 18 years and older who reside in or near Forsyth County, North Carolina

• Self-identified as Hispanic or Latino

• Evidence of pre-diabetes: Hemoglobin A1c of 5.7-6.5%

• Body Mass Index (BMI): 25-45 kg/m2

• Potential participants must be willing to accept randomization to either the intensive lifestyle intervention or the comparison usual care condition

Exclusion Criteria:

• Currently involved in a supervised program for weight loss

• Clinical history of diabetes or newly diagnosed diabetes at screening

• Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, congestive heart failure. All persons with recent CVD should be participating in cardiac rehabilitation (with appropriate supervision as indicated) to reduce their risk of recurrence; hence, randomization might raise ethical concerns.

• Uncontrolled high blood pressure (BP): BP > 160/100. Potential participants can be re-screened after control has been achieved.

• Pregnancy, breast feeding, or planning pregnancy within 2 years

• Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer

• Chronic use of medicine known to significantly affect glucose metabolism (e.g., corticosteroids, protease inhibitors)

• Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to La Comunidad, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), participation in another research study that would interfere with La Comunidad.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wake Forest School of Medicine	Winston-Salem	North Carolina	United States	27157

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

• Principal Investigator: Mara Z Vitolins, DrPH RDN, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 15, 2017

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01831921
• Other Study ID Numbers: IRB00022566; 1P60MD006917
• First Posted: Apr 15, 2013
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: pre diabetes; obesity; weight loss; lifestyle; prevention
• Additional relevant MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Prediabetic State; Glucose Intolerance

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	150	75
6 Months	122	63
12 Months	120	62
18 Months	90	49
COMPLETED	66	36
NOT COMPLETED	84	39

Baseline Characteristics

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	150	75	225
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	147 98%	71 94.7%	218 96.9%
>=65 years	3 2%	4 5.3%	7 3.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.6 (9.0)	41.8 (9.1)	41.6 (9.0)
Sex: Female, Male (Count of Participants)
Female	127 84.7%	64 85.3%	191 84.9%
Male	23 15.3%	11 14.7%	34 15.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	150 100%	75 100%	225 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	150 100%	75 100%	225 100%
Hemoglobin A1c (percent) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent]	6.0 (.30)	5.9 (.20)	5.9 (.3)
Body Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	81.9 (14.10)	80.3 (13.1)	81.4 (13.80)
Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	118.5 (13.8)	116.5 (14.5)	117.8 (14.0)
Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	71.9 (8.5)	69.9 (9.8)	71.3 (9.0)
Fasting Glucose (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	97.7 (9.9)	96.6 (9.6)	97.4 (9.8)
High Density Lipoprotien (HDL) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	45.3 (10.5)	46.5 (10.9)	45.7 (10.6)
Low Density Lipoprotein (LDL) (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	109.9 (28.50)	106.7 (28.10)	108.8 (28.40)
Triglycerides (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	142.1 (68.70)	140.1 (61.60)	141.4 (66.30)
Total Cholesterol (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	183.6 (33.10)	181.3 (36.6)	182.8 (34.30)

Outcome Measures

1. Primary Outcome

Title	Hemoglobin A1c
Description	Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Time Frame	6, 12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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 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.	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.
Measure Participants	150	75
6 Months	5.9 (.30)	5.8 (.30)
12 Months	5.9 (.30)	5.9 (.30)
18 Months	5.9 (.30)	5.9 (.30)
24 Months	6.0 (.40)	6.0 (.50)

2. Secondary Outcome

Title	Body Weight
Description	Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Time Frame	6, 12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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.	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.
Measure Participants	150	75
6 Months	79.2 (14.3)	77.4 (13.1)
12 Months	79.7 (14.1)	79.1 (13.9)
18 Months	79.9 (14.5)	78.7 (13.6)
24 Months	80.0 (13.7)	77.3 (12.2)

3. Secondary Outcome

Title	Systolic Blood Pressure
Description	Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Time Frame	6, 12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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.	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.
Measure Participants	150	75
6 Months	117.0 (14.5)	113.7 (12.9)
12 Months	116.7 (13.2)	114.3 (11.9)
18 Months	117.1 (12.6)	115.6 (12.8)
24 Months	119.7 (16.6)	116.8 (10.7)

4. Secondary Outcome

Title	Diastolic Blood Pressure
Description	Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Time Frame	6, 12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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.	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.
Measure Participants	150	75
6 Months	69.5 (9.4)	69.2 (9.5)
12 Months	70.0 (9.9)	71.2 (8.9)
18 Months	69.3 (9.3)	70.4 (8.1)
24 Months	70.5 (9.7)	70.7 (8.4)

5. Secondary Outcome

Title	Fasting Glucose
Description	Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.
Time Frame	6, 12, 18, and 24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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.	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.
Measure Participants	150	75
6 Months	96.3 (10.3)	96.3 (8.7)
12 Months	98.1 (10.1)	96.1 (11.6)
18 Months	98.0 (11.7)	98.6 (14.2)
24 Months	98.2 (10.5)	99.9 (17.9)

6. Secondary Outcome

Title	Total Cholesterol
Description	Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.
Time Frame	12, and 24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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.	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. Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
Measure Participants	150	75
12 Months	181.1 (35.5)	180.3 (36.9)
24 Months	184.7 (40.0)	174.4 (40.3)

7. Secondary Outcome

Title	High Density Lipoprotein (HDL)
Description	Mean HDL in both treatment groups at 12 and 24 months will be assessed.
Time Frame	12, and 24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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.	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. Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
Measure Participants	150	75
12 Months	47.3 (11.6)	47.5 (11.2)
24 Months	46.8 (10.5)	45.5 (9.8)

8. Secondary Outcome

Title	Low Density Lipoprotein (LDL)
Description	Mean LDL in both treatment groups at 12 and 24 months will be calculated.
Time Frame	12, and 24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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.	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. Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
Measure Participants	150	75
12 Months	106.7 (27.9)	106.5 (31.8)
24 Months	108.3 (31.4)	101.5 (25.4)

9. Secondary Outcome

Title	Triglycerides
Description	Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.
Time Frame	12, and 24 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Lifestyle Weight-Loss	Enhanced Usual Care
Arm/Group Description	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.	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. Counseling: Individual nutrition counseling will be delivered by a registered dietitian.
Measure Participants	150	75
12 Months	139.7 (76.6)	131.3 (56.7)
24 Months	147.7 (74.8)	139.3 (153.9)

10. Other Pre-specified Outcome

Title	Fasting Insulin
Description	Mean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed.
Time Frame	6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Other Pre-specified Outcome

Title	Homeostasis Model of Insulin Resistance (HOMA IR)
Description	Mean change in the HOMA IR model from baseline between treatment groups at 6, 12, and 24 months will be assessed.
Time Frame	6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Information on adverse events and serious adverse events was collected every 6 months for up to 24 months.
Arm/Group Title	Lifestyle Weight-Loss		Enhanced Usual Care
Arm/Group Description	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.		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.
All Cause Mortality
	Lifestyle Weight-Loss		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/150 (1.3%)		0/75 (0%)
Serious Adverse Events
	Lifestyle Weight-Loss		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/150 (2.7%)		1/75 (1.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
death from non-study related causes (colon cancer)	1/150 (0.7%)	1	0/75 (0%)	0
Surgical and medical procedures
Inpatient hospitalization for surgery	2/150 (1.3%)	2	1/75 (1.3%)	1
Vascular disorders
death from non-study related causes (aneurysm)	1/150 (0.7%)	1	0/75 (0%)	0
Other (Not Including Serious) Adverse Events
	Lifestyle Weight-Loss		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/150 (8.7%)		10/75 (13.3%)
Musculoskeletal and connective tissue disorders
Joint/Musculoskeletal Pain	13/150 (8.7%)	150	10/75 (13.3%)	75

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.