Clinical trial NCT03372018: Promotora-Led Intervention for Metabolic and Mental Health
Official title: Promotora Intervention for Metabolic and Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Obesity
Metabolic Disease
Body Weight Changes
Diabetes Mellitus
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-12-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Body Weight
timeFrame: 3 months
Secondary outcomes:
measure: Perceived Stress
timeFrame: 3 months
measure: Cardiometabolic marker - A1C
timeFrame: 3 months
measure: Cardiometabolic marker - waist circumference
timeFrame: 3 months
measure: Beck Depression Inventory
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Univeristy
state: Illinois
Study officials:
affiliation: Assistant Professor of Medicine and Preventive Medicine
name: Matthew J O'Brien, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: