Promotora-Led Intervention for Metabolic and Mental Health (PRIME2)

Northwestern University

Status: Completed

Conditions: Diabetes Mellitus; Obesity; Metabolic Disease; Body Weight Changes; PreDiabetes

Treatments: Behavioral: Promotora-led Intervention (PLI); Behavioral: Usual care (UC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03372018

STU00202244

R03DK109243 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

53 participants in 2 patient groups

Promotora-led intervention (PLI)

Experimental group

Description:

PLI -DPP protocol was developed from original DPP materials and culturally tailored for the target population based on formative research. The core PL-DPP curriculum includes 14 group sessions of 90 minutes duration. One promotora will lead each session in Spanish using behavioral strategies to discuss lifestyle behaviors, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.

Treatment:

Behavioral: Promotora-led Intervention (PLI)

Usual care (UC)

Active Comparator group

Description:

UC participants will receive standard educational materials in Spanish discussing mental health and diabetes prevention. UC participants will be encouraged to continue all routine medical care during the study.

Treatment:

Behavioral: Usual care (UC)