Reducing Weight and Diabetes Risk in an Underserved Population (STRIDE) (STRIDE)

March 12, 2015 updated by: Kaiser Permanente

Reducing Weight and Diabetes Risk in an Underserved Population

The purpose of this study is to examine the effectiveness of a lifestyle intervention designed to reduce weight and diabetes risk in a population of individuals with mental illness who are also taking antipsychotic medications. We will examine the effectiveness of the intervention in

  1. reducing weight and Body Mass Index;
  2. reducing fasting insulin levels and increasing insulin sensitivity; and
  3. reducing total cholesterol and LDL cholesterol.

Study Overview

Detailed Description

Overweight and obesity are among the leading causes of preventable deaths in the US, primarily through their effects on Type II diabetes mellitus and other cardiovascular disease risk factors. Individuals with serious mental illness represent a large underserved population at greatly increased risk of obesity, diabetes, metabolic syndrome, and subsequent early mortality. These risks are amplified by the antipsychotic agents that are often prescribed to treat these mental conditions.

Although strong evidence indicates that lifestyle interventions are effective at reducing weight and other diabetes risk factors in general populations, and pilot and feasibility studies suggest that such interventions will be effective with individuals who have mental illnesses, no large-scale translational trials have examined such interventions in this population.

STRIDE is a randomized controlled trial to examine the effectiveness, in a mentally ill population, of a lifestyle intervention previously shown to be effective for reducing weight and diabetes risk factors. We target a group of individuals taking antipsychotic agents (n = 280) who receive treatment in one of two clinical settings-a publicly funded behavioral health care clinic and a non-profit private health plan. Counselors from each clinical setting will be trained in the intervention and paired with study staff to deliver it, increasing generalizability, and improving the probability of future adoption. The intervention promotes moderate calorie reduction, dietary changes, and increased energy expenditure, and is based on current clinical practice guidelines for treating obesity and cardiovascular disease.

Specific aims test the hypotheses that the intervention is more effective than usual care in: 1) reducing weight and Body Mass Index; 2) reducing fasting insulin levels and increasing insulin sensitivity; and 3) reducing total cholesterol and LDL cholesterol. A fourth aim explores effects of motivation, social support, and outcomes expectancies on primary outcomes, and moderators of intervention effectiveness (ethnicity, gender, mental illness diagnostic group, medication type, metabolic syndrome) on outcomes.

Implementation and process evaluations will assess the fidelity of intervention delivery, evaluate its acceptability; identify components participants find most and least helpful; identify barriers to, and facilitators of, lifestyle changes; and evaluate the effects of the intervention on body image, psychiatric symptoms, adherence to antipsychotic medications, quality of life, health-related self-efficacy, health, functional status, and social support. Cost-effectiveness analyses will evaluate incremental costs of producing change in each primary outcome (weight, BMI, fasting insulin levels, insulin sensitivity, and cholesterol).

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97207
        • Cascadia Behavioral Healthcare
      • Portland, Oregon, United States, 97227-1110
        • Center for Health Research, Kaiser Permanente Northwest
      • Portland, Oregon, United States, 97229
        • LifeWorks Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age 18 and over
  2. stable on antipsychotic agents >1 month
  3. BMI in the range of 25-44.9 kg/m2
  4. approved by primary care provider or psychiatrist for participation (based on mental and physical health status)
  5. able and willing to provide informed consent
  6. access to telephone or e-mail (for maintenance phase)

Exclusion Criteria:

  1. children under age 18
  2. diagnosis of dementia
  3. psychiatrist or primary care provider indication of any medical or psychiatric contraindications for participating in a weight reduction/exercise program
  4. cardiovascular event within the past 6 months (if more remote history, eligible with primary care provider or psychiatrist approval)
  5. history of bariatric surgery
  6. cancer diagnosis or cancer treatment in the prior 2 years (except for non-melanoma skin cancer)
  7. currently pregnant or breastfeeding, or plan a pregnancy prior to the end of study participation
  8. mental health hospitalization in the 30 days prior to enrollment
  9. planning on moving out of the area before the 24-month follow-up assessment
  10. currently enrolled in a weight-reduction program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Premier Lifestyle Intervention with Dash Diet, adapted for populations with mental illnesses
Comprehensive group lifestyle intervention focused on caloric restriction and increased moderate exercise using the DASH Diet. 6 months intensive intervention (weekly, group meetings) followed by 6 months of a less-intensive maintenance intervention (monthly group meetings with monthly telephone/e-mail consult)
Other Names:
  • DASH Diet
No Intervention: 2
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index
Time Frame: 6, 12, 24 months
6, 12, 24 months
Weight
Time Frame: 6, 12, 24 months
6, 12, 24 months
Insulin sensitivity
Time Frame: 6, 12, 24 months
6, 12, 24 months
Fasting insulin levels
Time Frame: 6, 12, 24 months
6, 12, 24 months
Cholesterol levels
Time Frame: 6, 12, 24 months
6, 12, 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Body Image
Time Frame: 6, 12, 24 months
6, 12, 24 months
Antipsychotic Medication Adherence
Time Frame: 6, 12, 24 months
6, 12, 24 months
Psychiatric Symptoms
Time Frame: 6, 12, 24 months
6, 12, 24 months
Health-related self-efficacy
Time Frame: 6, 12, 24 months
6, 12, 24 months
Social support for diet/weight loss
Time Frame: 6, 12, 24 months
6, 12, 24 months
Quality of life
Time Frame: 6, 12, 24 months
6, 12, 24 months
Health/functional status
Time Frame: 6, 12, 24 months
6, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carla A Green, PhD, MPH, Center for Health Research, Kaiser Permanente Northwest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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