NCT03372018

Promotora-Led Intervention for Metabolic and Mental Health

Promotora Intervention for Metabolic and Mental Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• PreDiabetes
• Obesity
• Metabolic Disease
• Body Weight Changes
• Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Promotora-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.
BEHAVIORAL	Usual care (UC)	Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.

Timeline

• Start date: 2018-08-07
• Primary completion: 2019-03-22
• Completion: 2019-03-22
• First posted: 2017-12-13
• Last updated: 2019-06-05

Locations

1 site across 1 country: United States