Body Weight Changes, Diabetes Mellitus, Metabolic Disease, Obesity, PreDiabetes
Conditions
Brief summary
Evidence-based programs to prevent diabetes among high-risk individuals are less effective among those who also have mental health needs. This study involves developing and pilot testing the first adaptation of the landmark Diabetes Prevention Program lifestyle intervention to simultaneously treat prediabetes and elevated mental health symptoms. This project has large potential to impact public health, given that more than half of the U.S. adult population has either of these conditions, and is at risk for developing comorbid diabetes and mental illness.
Detailed description
The overall goal of this study is to develop an effective and potentially scalable intervention to prevent diabetes in people with elevated mental health symptoms (EMS) and prediabetes. This study focuses on Latinos, a demographic group at particularly high risk for these related conditions. Experience from the Diabetes Prevention Program (DPP), and related translational studies, suggests that the evidence-based DPP lifestyle intervention is less effective among depressed individuals. The proposed Promotora Intervention for Metabolic and Mental Health (PRIME2) will be the first adaptation of the DPP lifestyle intervention to simultaneously address mental health and prediabetes in a program delivered by promotoras, or community health workers.
Interventions
BEHAVIORALPromotora-led Intervention (PLI)
Behavioral life-style program with cognitive-behavioral content lead by a team of trained community health workers (called promotoras) with the following principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.
BEHAVIORALUsual care (UC)
Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Latino ethnicity * Spanish fluency * Age ≥18 years * BMI ≥25 kg/m2 * And increased risk of diabetes (ADA Diabetes Risk Score ≥5 as determined by 7-item questionnaire and/or hemoglobin A1C ≥ 5.7%)
Exclusion criteria
* Hemoglobin A1C ≥ 6.5% * Current or planned pregnancy during the study period * Chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease) * Medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and HIV) * Medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | 3 months | Weight change from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress | 3 months | The Perceived Stress Scale (PSS) is a 14-item tool meant to measure how different situations affect participant feelings and perceived stress. Individual scores on the PSS range from 0 to 40 with higher scores indicating higher perceived stress. Each item is rated on a 5-point scale ranging from never (0) to almost always (4).The total score reported for each participant. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress. |
| Cardiometabolic marker - A1C | 3 months | Hemoglobin A1C change from baseline measured from a fingerstick capillary blood sample using a DCA 2000/Vantage portable analyzer. |
| Cardiometabolic marker - waist circumference | 3 months | Waist circumference change from baseline assessed using a measuring tape around the top of the iliac crests at end-expiration. |
| Beck Depression Inventory | 3 months | levated depressive symptoms were assessed using the Beck Depression Inventory (BDI), a depression screening instrument. The BDI score recorded at the enrollment visit will be considered the baseline BDI score. The last measured BDI score within 3 months after the baseline visit is the follow-up score used to calculate mean BDI change. |
Countries
United States
Outcome results
None listed