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Completed

NCT Number: NCT02502929

Diabetes Risk Reduction Through Eat, Walk, Sleep and Medication Therapy Management for Depressed Cambodians

The primary aim of the study is to compare the effect of three different interventions on lifestyle risk factors and biological risk factors for type 2 diabetes in depressed Cambodians. The three different interventions are lifestyle, lifestyle plus medication therapy management, and social services.

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Key information

Conditions

Diabetes Behavior Behavioral Symptoms Depression Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uconn Health, Farmington, Connecticut, United States

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About this study

Cambodian Americans have high risk for major depressive disorder and for type 2 diabetes. Depression is a known risk factor for diabetes. Some antidepressants can also increase risk of diabetes by causing weight gain. DREAM will test the effect of lifestyle and medication therapy management (MTM) compared to social services (control) on diabetes risk among depressed Cambodian Americans. Community health workers (CHWs) will deliver the lifestyle intervention and assist pharmacists with MTM. Lifestyle and biological risk factors for diabetes, such as depressive symptoms, HbA1c and insulin sensitivity, will be measured before and after the interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identified as Cambodian or Cambodian-American
  • Khmer speaking
  • Likely major depressive disorder
  • Elevated diabetes risk score per ADA guidelines
  • Ambulatory
  • Competent to give consent.

Exclusion criteria

  • Pregnancy or plans to become pregnant in the next 2 years
  • Previous diagnosis of diabetes
  • Seeing or hearing problems that would interfere with group sessions
  • Currently being followed by a physician for major medical problem
  • Serious thinking or memory problems (e.g., schizophrenia or dementia)
  • 3 or more days in a psychiatric hospital or self-harm in the past 2 years.

Treatment and study plan

Social Services

Behavioral

Lifestyle

Behavioral

Lifestyle Plus Medication Therapy Management

Behavioral

Primary outcomes

  1. Lifestyle risk for type 2 diabetes

    Time frame: 12 months and 15 months

    Change from baseline in depressive symptoms according to the Hopkins Symptom Checklist

  2. Biological risk for type 2 diabetes

    Time frame: 12 months and 15 months

    Change from baseline in HbA1c and insulin resistance according to logHOMA-IR

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Khmer Health Advocates
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Penn State University

Registry information

Official study title

Lifestyle and Medication Management to Lower Diabetes Risk in Severe Mental Illness

Acronym: DREAM

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jul 20, 2015
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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