Latinos Combating Diabetes (La Comunidad)
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|ClinicalTrials.gov Identifier: NCT01831921|
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : July 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pre Diabetes Obesity Metabolic Syndrome||Behavioral: Lifestyle Weight Loss Behavioral: Counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Latinos Combatiendo la Diabetes (Latinos Combating Diabetes)|
|Actual Study Start Date :||April 2013|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
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 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.
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 an RD and monthly newsletters that focus on existing community resources.
Individual nutrition counseling will be delivered by a registered dietitian.
- Hemoglobin A1c [ Time Frame: 6, 12, 18, and 24 months ]Mean change in hemoglobin A1c from baseline between treatment groups at 6, 12, 18, and 24 months will be assessed.
- Body Weight [ Time Frame: 6, 12, 18, and 24 months ]Mean change in body weight from baseline between treatment groups at 6, 12, 18, and 24 months will be assessed.
- Blood Pressure [ Time Frame: 6, 12, 18, and 24 months ]Mean change in systolic and diastolic blood pressures from baseline between treatment groups at 6, 12, 18, and 24 months will be assessed.
- Fasting Glucose [ Time Frame: 6, 12, 18, and 24 months ]Mean change in fasting plasma glucose from baseline between treatment groups at 6, 12, 18, and 24 months will be assessed.
- Lipids [ Time Frame: 12 and 24 months ]Mean changes in total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides from baseline between treatment groups at 12 and 24 months will be assessed.
- Fasting Insulin [ Time Frame: 6, 12, and 24 months ]
- Homeostasis model of insulin resistance (HOMA IR) [ Time Frame: 6, 12, 18, and 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831921
|United States, North Carolina|
|Wake Forest School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Mara Z Vitolins, DrPH RDN||Wake Forest University Health Sciences|