Reducing Weight and Diabetes Risk in an Underserved Population - Full Text View

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

This study is not yet open for participant recruitment.

Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), March 2009

First Received: March 19, 2009 No Changes Posted

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Cascadia Behavioral Healthcare Oregon Health and Science University University of Medicine and Dentistry New Jersey
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00866372

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: Lifestyle Intervention

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Efficacy Study
Official Title:	Reducing Weight and Diabetes Risk in an Underserved Population

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

reducing weight and BMI [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	June 2009
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Center for Health Research, Kaiser Permanente NW ( Carla A. Green, PhD, MPH, Senior Investigator )
Study ID Numbers:	DK76775
Study First Received:	March 19, 2009
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00866372 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Overweight
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Metabolic Diseases
Diabetes Mellitus

Endocrine System Diseases
Overweight
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009