N/A
N=195
De Por Vida: A Diabetes Risk Reduction Intervention for Hispanic Women
Diabetes · Weight Loss · PreDiabetes · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03113916 ↗Enrolled (actual)
195
Serious AEs
3.5%
Results posted
Sep 2020
Primary outcome: Primary: Weight in Kilograms — 87.1; 86.3; 84.4; 85.9 kilograms — p==.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioural Lifestyle Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kaiser Permanente
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight in Kilograms |
87.1; 86.3; 84.4; 85.9; 84.2; 85.8 | =.001 sig |
| PRIMARY Waist Circumference in Centimeters |
115.2; 115.6; 113.5; 114.7; 112.9; 114.5 | .23 |
| SECONDARY Hemoglobin HbA1c % (Transformed Using the Inverse Cube, or 1/HbAlc%^3) |
.00448; .00445; .00445; .00439; .00437; .00423 | .06 |
| SECONDARY Fasting Blood Glucose (Fbg; Transformed Using the Inverse Square, or 1/Fbg in mg/dl^2 ) |
.0000699; .0000668; .0000699; .000067; .0000695; .0000676 | .29 |
| SECONDARY Total Cholesterol |
195.6; 191.9; 199.5; 193.8; 203.5; 195.6 | .27 |
| SECONDARY Number of Fruit Servings Per Day (Transformed Using the Natural Log) |
.637; .511; .522; .483; .406; .456 | .10 |
| SECONDARY Number of Kilocalories |
1546; 1431; 1381; 1333; 1215; 1234 | .07 |
| SECONDARY Sugar Intake in Grams |
79.9; 72.6; 70.2; 66.7; 60.5; 60.8 | .12 |
| SECONDARY Dietary Fiber Intake in Grams (Transformed Using the Natural Log) |
3.15; 3.01; 2.87; 2.90; 2.87; 2.90 | .008 sig |
| SECONDARY Saturated Fat Intake as Percentage of Total Energy Intake |
9.13; 9.40; 8.80; 8.98; 8.47; 8.56 | .50 |
| SECONDARY Number of Vegetable Servings Per Day (Transformed Using the Natural Log) |
1.37; 1.27; 1.30; 1.20; 1.22; 1.13 | .99 |
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.
Eligibility Criteria
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
- Female
- 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.
Data sourced from ClinicalTrials.gov (NCT03113916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.