Intervention to Promote Weight Loss in Latinas At-risk for Diabetes

Detailed Description This lifestyle intervention condition will be compared to a usual care (UC) condition. The aim of this study is to 1) develop a protocol-based, promotora-led lifestyle intervention (PLI) to promote weight loss in at-risk Latinas, and assess its feasibility, and 2) compare changes in weight and cardiometabolic markers—hemoglobin A1C, fasting lipids, blood pressure—from baseline to 1 year between at-risk Latinas randomly assigned to the PLI group versus the usual care (UC) group. The investigators hypothesize that 1) Latinas assigned to PLI will have greater weight loss (primary outcome) and greater improvements in cardiometabolic markers from baseline to 1 year than those randomized to UC.

Primary Outcome Measures:

Body weight [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardiometabolic markers [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] Cardiometabolic markers include: serum glucose, insulin, lipid panel, hemoglobin A1C, waist circumference, and blood pressure.

Physical activity [ Time Frame: 1 year ] [ Designated as safety issue: No ] Physical activity (PA) for 7 days will be measured at baseline, 6 months, and 1 year using Actigraph GT3X accelerometers worn on the hip.

Dietary intake [ Time Frame: 1 year ] [ Designated as safety issue: No ] Food frequency questionnaire

Diabetes knowledge [ Time Frame: 1 year ] [ Designated as safety issue: No ] Spanish-speaking Diabetes Knowledge Questionnaire (DKQ). Validated, 24-item questionnaire.

ClinicalTrials.gov Identifier: NCT02088034

Link to ClinicalTrials.gov Study Record