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

NCT00790517 | Completed Phase 2 DMC

• 1 other identifier: R18DK076775
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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

Conditions

Weight Loss; Diabetes Mellitus, Type 2; Psychotic Disorders

Keywords

Weight loss; Diabetes prevention; Serious mental illness; Antipsychotic medications; Lifestyle intervention; Antipsychotic Agents

Outcome Measures

Primary Outcomes (5)

• Body Mass Index

  6, 12, 24 months

• Weight

  6, 12, 24 months

• Insulin sensitivity

  6, 12, 24 months

• Fasting insulin levels

  6, 12, 24 months

• Cholesterol levels

  6, 12, 24 months

Secondary Outcomes (7)

• Body Image

  6, 12, 24 months

• Antipsychotic Medication Adherence

  6, 12, 24 months

• Psychiatric Symptoms

  6, 12, 24 months

• Health-related self-efficacy

  6, 12, 24 months

• Social support for diet/weight loss

  6, 12, 24 months

Study Arms (2)

1

EXPERIMENTAL

Premier Lifestyle Intervention with Dash Diet, adapted for populations with mental illnesses

Behavioral: Premier Lifestyle Intervention with DASH Diet

2

NO INTERVENTION

Usual care

Interventions

Premier Lifestyle Intervention with DASH Diet BEHAVIORAL

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)

Also known as: DASH Diet

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• LifeWorks Northwest: collaborator
• Cascadia Behavioral Healthcare: collaborator

Study Sites (3)

Cascadia Behavioral Healthcare

Portland, Oregon, 97207, United States

Location

Center for Health Research, Kaiser Permanente Northwest

Portland, Oregon, 97227-1110, United States

Location

LifeWorks Northwest

Portland, Oregon, 97229, United States

Location

Related Publications (3)

• Yarborough BJ, Leo MC, Yarborough MT, Stumbo S, Janoff SL, Perrin NA, Green CA. Improvement in Body Image, Perceived Health, and Health-Related Self-Efficacy Among People With Serious Mental Illness: The STRIDE Study. Psychiatr Serv. 2016 Mar;67(3):296-301. doi: 10.1176/appi.ps.201400535. Epub 2015 Nov 2.

  PMID: 26522674 DERIVED

• Green CA, Yarborough BJ, Leo MC, Yarborough MT, Stumbo SP, Janoff SL, Perrin NA, Nichols GA, Stevens VJ. The STRIDE weight loss and lifestyle intervention for individuals taking antipsychotic medications: a randomized trial. Am J Psychiatry. 2015 Jan;172(1):71-81. doi: 10.1176/appi.ajp.2014.14020173. Epub 2014 Oct 31.

  PMID: 25219423 DERIVED

• Yarborough BJ, Leo MC, Stumbo S, Perrin NA, Green CA. STRIDE: a randomized trial of a lifestyle intervention to promote weight loss among individuals taking antipsychotic medications. BMC Psychiatry. 2013 Sep 28;13:238. doi: 10.1186/1471-244X-13-238.

  PMID: 24074269 DERIVED

MeSH Terms

Conditions

Weight Loss; Diabetes Mellitus, Type 2; Psychotic Disorders

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Carla A Green, PhD, MPH

  Center for Health Research, Kaiser Permanente Northwest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: November 13, 2008
• Study Start: June 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 17, 2015

Record last verified: 2015-03

Locations

US (3)