Metabolic Syndrome, Obesity, Pre Diabetes
Conditions
Keywords
pre diabetes, obesity, weight loss, lifestyle, prevention
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.
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.
Interventions
BEHAVIORALLifestyle Weight Loss
Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
BEHAVIORALCounseling
Individual nutrition counseling will be delivered by a registered dietitian.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Low Density Lipoprotein (LDL) | 12, and 24 months | Mean LDL in both treatment groups at 12 and 24 months will be calculated. |
| Triglycerides | 12, and 24 months | Mean triglycerides in both treatment groups at 12 and 24 months will be calculated. |
| Total Cholesterol | 12, and 24 months | Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed. |
| High Density Lipoprotein (HDL) | 12, and 24 months | Mean HDL in both treatment groups at 12 and 24 months will be assessed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 150 |
| 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. | 75 |
| Total | 225 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Lifestyle Weight-Loss | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants | 147 Participants | 218 Participants |
| Age, Continuous | 41.8 years STANDARD_DEVIATION 9.1 | 41.6 years STANDARD_DEVIATION 9 | 41.6 years STANDARD_DEVIATION 9 |
| Body Weight | 80.3 kilograms STANDARD_DEVIATION 13.1 | 81.9 kilograms STANDARD_DEVIATION 14.1 | 81.4 kilograms STANDARD_DEVIATION 13.8 |
| Diastolic Blood Pressure | 69.9 mmHg STANDARD_DEVIATION 9.8 | 71.9 mmHg STANDARD_DEVIATION 8.5 | 71.3 mmHg STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 75 Participants | 150 Participants | 225 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting Glucose | 96.6 mg/dL STANDARD_DEVIATION 9.6 | 97.7 mg/dL STANDARD_DEVIATION 9.9 | 97.4 mg/dL STANDARD_DEVIATION 9.8 |
| Hemoglobin A1c | 5.9 percent STANDARD_DEVIATION 0.2 | 6.0 percent STANDARD_DEVIATION 0.3 | 5.9 percent STANDARD_DEVIATION 0.3 |
| High Density Lipoprotien (HDL) | 46.5 mg/dL STANDARD_DEVIATION 10.9 | 45.3 mg/dL STANDARD_DEVIATION 10.5 | 45.7 mg/dL STANDARD_DEVIATION 10.6 |
| Low Density Lipoprotein (LDL) | 106.7 mg/dL STANDARD_DEVIATION 28.1 | 109.9 mg/dL STANDARD_DEVIATION 28.5 | 108.8 mg/dL STANDARD_DEVIATION 28.4 |
| Region of Enrollment United States | 75 Participants | 150 Participants | 225 Participants |
| Sex: Female, Male Female | 64 Participants | 127 Participants | 191 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 34 Participants |
| Systolic Blood Pressure | 116.5 mmHg STANDARD_DEVIATION 14.5 | 118.5 mmHg STANDARD_DEVIATION 13.8 | 117.8 mmHg STANDARD_DEVIATION 14 |
| Total Cholesterol | 181.3 mg/dL STANDARD_DEVIATION 36.6 | 183.6 mg/dL STANDARD_DEVIATION 33.1 | 182.8 mg/dL STANDARD_DEVIATION 34.3 |
| Triglycerides | 140.1 mg/dL STANDARD_DEVIATION 61.6 | 142.1 mg/dL STANDARD_DEVIATION 68.7 | 141.4 mg/dL STANDARD_DEVIATION 66.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 150 | 0 / 75 |
| other Total, other adverse events | 13 / 150 | 10 / 75 |
| serious Total, serious adverse events | 4 / 150 | 1 / 75 |
Outcome results
Primary
Hemoglobin A1c
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Weight-Loss | Hemoglobin A1c | 12 Months | 5.9 percent HbA1c | Standard Deviation 0.3 |
| Lifestyle Weight-Loss | Hemoglobin A1c | 18 Months | 5.9 percent HbA1c | Standard Deviation 0.3 |
| Lifestyle Weight-Loss | Hemoglobin A1c | 24 Months | 6.0 percent HbA1c | Standard Deviation 0.4 |
| Lifestyle Weight-Loss | Hemoglobin A1c | 6 Months | 5.9 percent HbA1c | Standard Deviation 0.3 |
| Enhanced Usual Care | Hemoglobin A1c | 24 Months | 6.0 percent HbA1c | Standard Deviation 0.5 |
| Enhanced Usual Care | Hemoglobin A1c | 6 Months | 5.8 percent HbA1c | Standard Deviation 0.3 |
| Enhanced Usual Care | Hemoglobin A1c | 12 Months | 5.9 percent HbA1c | Standard Deviation 0.3 |
| Enhanced Usual Care | Hemoglobin A1c | 18 Months | 5.9 percent HbA1c | Standard Deviation 0.3 |
Secondary
Body Weight
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Weight-Loss | Body Weight | 6 Months | 79.2 kilograms | Standard Deviation 14.3 |
| Lifestyle Weight-Loss | Body Weight | 12 Months | 79.7 kilograms | Standard Deviation 14.1 |
| Lifestyle Weight-Loss | Body Weight | 18 Months | 79.9 kilograms | Standard Deviation 14.5 |
| Lifestyle Weight-Loss | Body Weight | 24 Months | 80.0 kilograms | Standard Deviation 13.7 |
| Enhanced Usual Care | Body Weight | 24 Months | 77.3 kilograms | Standard Deviation 12.2 |
| Enhanced Usual Care | Body Weight | 6 Months | 77.4 kilograms | Standard Deviation 13.1 |
| Enhanced Usual Care | Body Weight | 18 Months | 78.7 kilograms | Standard Deviation 13.6 |
| Enhanced Usual Care | Body Weight | 12 Months | 79.1 kilograms | Standard Deviation 13.9 |
Secondary
Diastolic Blood Pressure
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Weight-Loss | Diastolic Blood Pressure | 6 Months | 69.5 mmHg | Standard Deviation 9.4 |
| Lifestyle Weight-Loss | Diastolic Blood Pressure | 24 Months | 70.5 mmHg | Standard Deviation 9.7 |
| Lifestyle Weight-Loss | Diastolic Blood Pressure | 12 Months | 70.0 mmHg | Standard Deviation 9.9 |
| Lifestyle Weight-Loss | Diastolic Blood Pressure | 18 Months | 69.3 mmHg | Standard Deviation 9.3 |
| Enhanced Usual Care | Diastolic Blood Pressure | 12 Months | 71.2 mmHg | Standard Deviation 8.9 |
| Enhanced Usual Care | Diastolic Blood Pressure | 24 Months | 70.7 mmHg | Standard Deviation 8.4 |
| Enhanced Usual Care | Diastolic Blood Pressure | 6 Months | 69.2 mmHg | Standard Deviation 9.5 |
| Enhanced Usual Care | Diastolic Blood Pressure | 18 Months | 70.4 mmHg | Standard Deviation 8.1 |
Secondary
Fasting Glucose
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Weight-Loss | Fasting Glucose | 6 Months | 96.3 mg/dL | Standard Deviation 10.3 |
| Lifestyle Weight-Loss | Fasting Glucose | 12 Months | 98.1 mg/dL | Standard Deviation 10.1 |
| Lifestyle Weight-Loss | Fasting Glucose | 18 Months | 98.0 mg/dL | Standard Deviation 11.7 |
| Lifestyle Weight-Loss | Fasting Glucose | 24 Months | 98.2 mg/dL | Standard Deviation 10.5 |
| Enhanced Usual Care | Fasting Glucose | 24 Months | 99.9 mg/dL | Standard Deviation 17.9 |
| Enhanced Usual Care | Fasting Glucose | 6 Months | 96.3 mg/dL | Standard Deviation 8.7 |
| Enhanced Usual Care | Fasting Glucose | 18 Months | 98.6 mg/dL | Standard Deviation 14.2 |
| Enhanced Usual Care | Fasting Glucose | 12 Months | 96.1 mg/dL | Standard Deviation 11.6 |
Secondary
High Density Lipoprotein (HDL)
Mean HDL in both treatment groups at 12 and 24 months will be assessed.
Time frame: 12, and 24 months
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Weight-Loss | High Density Lipoprotein (HDL) | 12 Months | 47.3 mg/dL | Standard Deviation 11.6 |
| Lifestyle Weight-Loss | High Density Lipoprotein (HDL) | 24 Months | 46.8 mg/dL | Standard Deviation 10.5 |
| Enhanced Usual Care | High Density Lipoprotein (HDL) | 12 Months | 47.5 mg/dL | Standard Deviation 11.2 |
| Enhanced Usual Care | High Density Lipoprotein (HDL) | 24 Months | 45.5 mg/dL | Standard Deviation 9.8 |
Secondary
Low Density Lipoprotein (LDL)
Mean LDL in both treatment groups at 12 and 24 months will be calculated.
Time frame: 12, and 24 months
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Weight-Loss | Low Density Lipoprotein (LDL) | 12 Months | 106.7 mg/dL | Standard Deviation 27.9 |
| Lifestyle Weight-Loss | Low Density Lipoprotein (LDL) | 24 Months | 108.3 mg/dL | Standard Deviation 31.4 |
| Enhanced Usual Care | Low Density Lipoprotein (LDL) | 12 Months | 106.5 mg/dL | Standard Deviation 31.8 |
| Enhanced Usual Care | Low Density Lipoprotein (LDL) | 24 Months | 101.5 mg/dL | Standard Deviation 25.4 |
Secondary
Systolic Blood Pressure
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Weight-Loss | Systolic Blood Pressure | 18 Months | 117.1 mmHg | Standard Deviation 12.6 |
| Lifestyle Weight-Loss | Systolic Blood Pressure | 6 Months | 117.0 mmHg | Standard Deviation 14.5 |
| Lifestyle Weight-Loss | Systolic Blood Pressure | 24 Months | 119.7 mmHg | Standard Deviation 16.6 |
| Lifestyle Weight-Loss | Systolic Blood Pressure | 12 Months | 116.7 mmHg | Standard Deviation 13.2 |
| Enhanced Usual Care | Systolic Blood Pressure | 24 Months | 116.8 mmHg | Standard Deviation 10.7 |
| Enhanced Usual Care | Systolic Blood Pressure | 12 Months | 114.3 mmHg | Standard Deviation 11.9 |
| Enhanced Usual Care | Systolic Blood Pressure | 18 Months | 115.6 mmHg | Standard Deviation 12.8 |
| Enhanced Usual Care | Systolic Blood Pressure | 6 Months | 113.7 mmHg | Standard Deviation 12.9 |
Secondary
Total Cholesterol
Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.
Time frame: 12, and 24 months
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Weight-Loss | Total Cholesterol | 12 Months | 181.1 mg/dL | Standard Deviation 35.5 |
| Lifestyle Weight-Loss | Total Cholesterol | 24 Months | 184.7 mg/dL | Standard Deviation 40 |
| Enhanced Usual Care | Total Cholesterol | 12 Months | 180.3 mg/dL | Standard Deviation 36.9 |
| Enhanced Usual Care | Total Cholesterol | 24 Months | 174.4 mg/dL | Standard Deviation 40.3 |
Secondary
Triglycerides
Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.
Time frame: 12, and 24 months
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Weight-Loss | Triglycerides | 24 Months | 147.7 mg/dL | Standard Deviation 74.8 |
| Lifestyle Weight-Loss | Triglycerides | 12 Months | 139.7 mg/dL | Standard Deviation 76.6 |
| Enhanced Usual Care | Triglycerides | 24 Months | 139.3 mg/dL | Standard Deviation 153.9 |
| Enhanced Usual Care | Triglycerides | 12 Months | 131.3 mg/dL | Standard Deviation 56.7 |
Other Pre-specified
Fasting Insulin
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
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.
Time frame: 6, 12, and 24 months