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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cascadia Behavioral Healthcare
LifeWorks Northwest
Oregon Health and Science University
University of Medicine and Dentistry New Jersey
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00866372
First received: March 19, 2009
Last updated: February 28, 2012
Last verified: February 2012
History of Changes
  Purpose

This study will examine whether a lifestyle change program to reduce weight and diabetes risk factors will be effective among people with serious mental illnesses. If the results are positive, it could help people with mental illness improve their health and reduce their diabetes risk.


Condition Intervention
Diabetes Mellitus
Overweight
 Behavioral: Life style Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing Weight and Diabetes Risk in an Underserved Population

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • reducing weight and BMI [ Time Frame: Baseline, 6-, 12-, and 24-months ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: October 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Life style Intervention
    Translational randomized controlled trial assessing the effectiveness of a known efficacious and comprehensive lifestyle intervention in an underserved mentally ill population at high risk for obesity and diabetes.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age ≥18
  • taking antipsychotic agents
  • overweight or obese (BMI of 25-44.9)

Exclusion Criteria:

  • diagnoses of dementia
  • serious illnesses,including cancer or bariatric surgery history
  • women who are pregnant, breastfeeding, or plan a pregnancy during the study
  • recent (prior 30 days) mental health hospitalizations
  • enrollment in another weight reduction program
  • those planning to move outside the area before the trial is complete (to prevent attrition)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866372

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Cascadia Behavioral Healthcare
LifeWorks Northwest
Oregon Health and Science University
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Carla A Green, PhD, MPH Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00866372     History of Changes
Other Study ID Numbers: R18 DK76775, R18DK076775
Study First Received: March 19, 2009
Last Updated: February 28, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013