Culturally Competent Behavioral Intervention for Diabetes Risk Reduction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kaiser Permanente
- Enrollment
- 195
- Primary Endpoint
- Weight in Kilograms
Study Overview
Brief Summary
This pragmatic randomized clinical trial will assess the efficacy, cost, and sustainability of a culturally tailored weight-loss program targeting obese Hispanic women with pre-diabetes or T2D. The intervention will be integrated into patient care at a Federally Qualified Health Center serving over 30,000 low-income patients, and will be delivered by trained clinic staff, with minimal support from research staff. After the effectiveness clinical trial, two cohorts of clinic patients will receive the intervention in a sustainability test.
Detailed Description
Hispanic women have the highest estimated lifetime risk of developing diabetes of all ethnic/gender groups in the US, and their prevalence rates of overweight and obesity are among the highest in the US. Currently, nearly 90% of Hispanic women aged 40-59 are overweight or obese. If diagnosed with Type 2 diabetes (T2D) at age 40, Hispanic women are projected to lose 12.4 life-years, and 21.5 quality-adjusted life-years.
Several clinical trials have produced compelling evidence demonstrating the benefits of weight-loss interventions for both diabetic and pre-diabetic individuals, but most of the successful interventions tested in large clinical trials have been too costly for implementation in community settings, and they have not been assessed under real life conditions, targeting vulnerable populations.
This study builds on the investigators' success with a culturally-tailored weight-loss intervention designed for Hispanic women. Elements of cultural adaptation will include: women-only groups, skill-building tasks around food measurement, focus on traditional dietary habits and cultural norms regulating food preparation and consumption, interactive learning formats with a minimum of written materials, culturally congruent physical activity, and addressing acculturative concerns.
Follow-up data, including change in weight, waist circumference, and diabetes outcomes, will be collected at 6-, 12-, and 18-months post randomization. Additional analyses will include the cost of delivering the intervention and assessing the intervention's sustainability. The results of this study will inform the development of interventions to prevent diabetes onset or manage T2D in this population.
Description of Measures Used
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All participants will be patients who receive their primary medical care at the Virginia Garcia Memorial Health Center (VGMHC)
- •Self-identified as Spanish-speaking Latina or Hispanic
- •Age 18 and older
- •BMI greater than or equal to 27kg/m2
- •Classified as diabetic or prediabetic in the electronic medical record by at least one of the following:
- •Fasting plasma glucose ≥ 100
- •2-h post glucose level on the 75-g oral glucose tolerance test ≥ 140-199 mg/dL (7.8-11.0 mmol/L)
- •Hemoglobin HBA1c ≥ 5.7
- •Diagnosis of diabetes in patient's medical chart
- •Diagnosis of prediabetes in patient's medical chart
- •Residing in the Portland metropolitan area, and having no plans to leave the area in the next 18 months.
- •Willing and able to attend the 26-weekly group meetings and 6 monthly group meetings.
- •Willing to accept random assignment to the active intervention or enhanced usual care control.
- •Clearance by the patient's VGMHC primary care physician to participate in the intervention.
Exclusion Criteria
- •Treatment for cancer in the past two years (excluding non-melanoma skin cancers).
- •Having conditions that require limitation of physical activity or that would be contraindicated for the DASH (Dietary Approaches to Stop Hypertension) diet patterns.
- •Taking weight-loss medication currently or within the past 6 months.
- •Current or recent (< 12 months) pregnancy, breastfeeding, or planning pregnancy in the next 18 months.
Arms & Interventions
Behavioral
26 weekly behavioral intervention sessions 6 monthly behavioral intervention sessions Sessions focused on diet, physical activity, behavior change
Intervention: Behavioural Lifestyle Intervention (Behavioral)
Enhanced usual care
Printed materials
Outcomes
Primary Outcomes
Weight in Kilograms
Time Frame: Baseline, 6, 12, and 18 months
Comparison of body weight trajectories in kilograms between the intervention and usual-care control groups.
Waist Circumference in Centimeters
Time Frame: Baseline, 6, 12, and 18 months
Comparison of waist circumference trajectories in centimeters between the intervention and usual-care control groups.
Secondary Outcomes
- Sugar Intake in Grams(Baseline, 6, 12, and 18 months)
- Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3)(Baseline, 6, 12 and 18 months from enrollment)
- Dietary Fiber Intake in Grams (Transformed Using the Natural Log)(Baseline, 6, 12, and 18 months)
- Saturated Fat Intake as Percentage of Total Energy Intake(Baseline, 6, 12, and 18 months)
- Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 )(Baseline, 6, 12, and 18 months)
- Total Cholesterol(Baseline, 6, 12, and 18 months)
- Number of Fruit Servings Per Day (Transformed Using the Natural Log)(Baseline, 6, 12, and 18 months)
- Number of Kilocalories(Baseline, 6, 12, and 18 months)
- Number of Vegetable Servings Per Day (Transformed Using the Natural Log)(Baseline, 6, 12, and 18 months)