Promotora-Led Intervention for Metabolic and Mental Health

Not Applicable

Completed

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

• Registration Number: NCT03372018
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-13
• Study Start: 2018-08-07
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-03
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Weight	3 months	Weight change from baseline.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Northwestern Univeristy; 🇺🇸 Chicago, Illinois, United States