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

Diabetes Mellitus, Type 2 Clinical Trial

— STRIDE  

Official title:

Reducing Weight and Diabetes Risk in an Underserved Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790517
• Other study ID #: R18DK076775
• Secondary ID: R18DK076775
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2008
• Last updated: March 12, 2015
• Start date: June 2009
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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).

Other known NCT identifiers

• NCT00866372

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus, Type 2
• Mental Disorders
• Psychotic Disorders
• Weight Loss

Intervention

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)

Locations

Country	Name	City	State
United States	Cascadia Behavioral Healthcare	Portland	Oregon
United States	Center for Health Research, Kaiser Permanente Northwest	Portland	Oregon
United States	LifeWorks Northwest	Portland	Oregon

Sponsors (4)

Lead Sponsor	Collaborator
Kaiser Permanente	Cascadia Behavioral Healthcare, LifeWorks Northwest, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		6, 12, 24 months	No
Primary	Weight		6, 12, 24 months	No
Primary	Insulin sensitivity		6, 12, 24 months	No
Primary	Fasting insulin levels		6, 12, 24 months	No
Primary	Cholesterol levels		6, 12, 24 months	No
Secondary	Body Image		6, 12, 24 months	No
Secondary	Antipsychotic Medication Adherence		6, 12, 24 months	No
Secondary	Psychiatric Symptoms		6, 12, 24 months	No
Secondary	Health-related self-efficacy		6, 12, 24 months	No
Secondary	Social support for diet/weight loss		6, 12, 24 months	No
Secondary	Quality of life		6, 12, 24 months	No
Secondary	Health/functional status		6, 12, 24 months	No