Promotora-Led Intervention for Metabolic and Mental Health

NCT03372018 | Completed DMC

• 2 other identifiers: STU00202244R03DK109243
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Weight change from baseline.

  3 months

Secondary Outcomes (4)

• Perceived Stress

  3 months

• Cardiometabolic marker - A1C

  3 months

• Cardiometabolic marker - waist circumference

  3 months

• Beck Depression Inventory

  3 months

Study Arms (2)

Promotora-led intervention (PLI)

EXPERIMENTAL

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.

Behavioral: Promotora-led Intervention (PLI)

Usual care (UC)

ACTIVE COMPARATOR

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.

Behavioral: Usual care (UC)

Interventions

Promotora-led Intervention (PLI) 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.

Promotora-led intervention (PLI)

Usual care (UC) BEHAVIORAL

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

Usual care (UC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Northwestern Univeristy

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prediabetic State; Obesity; Metabolic Diseases; Body Weight Changes; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew J O'Brien, MD, MSc

  Assistant Professor of Medicine and Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Preventive Medicine

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 13, 2017
• Study Start: August 7, 2018
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)