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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
LifeWorks Northwest
Cascadia Behavioral Healthcare
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00790517
First received: September 12, 2008
Last updated: February 11, 2014
Last verified: February 2011
  Purpose

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.

Condition Intervention Phase
Weight Loss
Diabetes Mellitus, Type 2
Psychotic Disorders
Behavioral: Premier Lifestyle Intervention with DASH Diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Weight and Diabetes Risk in an Underserved Population

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Body Mass Index [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Insulin sensitivity [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Fasting insulin levels [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Cholesterol levels [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body Image [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Antipsychotic Medication Adherence [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Psychiatric Symptoms [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Health-related self-efficacy [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Social support for diet/weight loss [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
  • Health/functional status [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Premier Lifestyle Intervention with Dash Diet, adapted for populations with mental illnesses
Behavioral: Premier Lifestyle Intervention with DASH Diet
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 Name: DASH Diet
No Intervention: 2
Usual care

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790517

Locations
United States, Oregon
Center for Health Research, Kaiser Permanente Northwest
Portland, Oregon, United States, 97227-1110
Cascadia Behavioral Healthcare
Portland, Oregon, United States, 97207
LifeWorks Northwest
Portland, Oregon, United States, 97229
Sponsors and Collaborators
Kaiser Permanente
LifeWorks Northwest
Cascadia Behavioral Healthcare
Investigators
Principal Investigator: Carla A Green, PhD, MPH Center for Health Research, Kaiser Permanente Northwest
  More Information

No publications provided by Kaiser Permanente

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00790517     History of Changes
Obsolete Identifiers: NCT00866372
Other Study ID Numbers: R18DK076775
Study First Received: September 12, 2008
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Weight loss
Diabetes prevention
Serious mental illness
Antipsychotic medications
Lifestyle intervention
Antipsychotic Agents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Psychotic Disorders
Mental Disorders
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Schizophrenia and Disorders with Psychotic Features
Body Weight Changes
Body Weight
Signs and Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 20, 2014