Promotora-Led Intervention for Metabolic and Mental Health

NCT ID: NCT03372018

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2019-03-22

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Promotora-led intervention (PLI)

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.

Group Type: EXPERIMENTAL

Promotora-led Intervention (PLI)

Intervention Type: BEHAVIORAL

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.

Usual care (UC)

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.

Group Type: ACTIVE_COMPARATOR

Usual care (UC)

Intervention Type: BEHAVIORAL

Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care (UC)

Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Matthew J O'Brien

Assistant Professor of Medicine and Preventive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew J O'Brien, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine and Preventive Medicine

Locations

Northwestern Univeristy

Chicago, Illinois, United States

Countries

United States

Other Identifiers

R03DK109243

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00202244

Identifier Type: -

Identifier Source: org_study_id