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Weight LossSTRIDENCT00790517

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

A study testing Premier Lifestyle Intervention with DASH Diet in people with Weight Loss and Diabetes Mellitus, Type 2, run by Kaiser Permanente at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Premier Lifestyle Intervention with DASH Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesUnited States
Study dates
Jun 2009to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Cascadia Behavioral Healthcare

    Portland, Oregon, 97207

  • Center for Health Research, Kaiser Permanente Northwest

    Portland, Oregon, 97227-1110

  • LifeWorks Northwest

    Portland, Oregon, 97229

Other trials in United States

About this study

Official title: Reducing Weight and Diabetes Risk in an Underserved Population

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.
Read the 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).

Being tested
Premier Lifestyle Intervention with DASH Diet
Keywords
Weight loss, Diabetes prevention, Serious mental illness, Antipsychotic medications, Lifestyle intervention, Antipsychotic Agents
Medical subject headings
Weight Loss, Diabetes Mellitus, Type 2, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Premier Lifestyle Intervention with DASH DietBehavioural

    Also called 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)

Study groups in NCT00790517
Study groupRoleWhat they receive
1ExperimentalPremier Lifestyle Intervention with Dash Diet, adapted for populations with mental illnesses
Receives: Behavioral: Premier Lifestyle Intervention with DASH Diet
2No interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index

    Measured: 6, 12, 24 months

  2. Weight

    Measured: 6, 12, 24 months

  3. Insulin sensitivity

    Measured: 6, 12, 24 months

  4. Fasting insulin levels

    Measured: 6, 12, 24 months

  5. Cholesterol levels

    Measured: 6, 12, 24 months

Secondary outcomes (7)

  1. Body Image

    Measured: 6, 12, 24 months

  2. Antipsychotic Medication Adherence

    Measured: 6, 12, 24 months

  3. Psychiatric Symptoms

    Measured: 6, 12, 24 months

  4. Health-related self-efficacy

    Measured: 6, 12, 24 months

  5. Social support for diet/weight loss

    Measured: 6, 12, 24 months

  6. Quality of life using the Wisconsin Quality of Life assessment

    Quality of life measures including: Life Satisfaction (scale: -3 to 3, higher score is better), Occupational Activities (scale: 1-5, higher score is better), Psychological Well Being (scale: 3/0, higher score is better; and -3/0, lower score is worse), Physical Health (scale: -3 to 3, higher score is better), Social Relations (scale: -3 to 3, higher score is better), Economics (scale: -3 to 3, higher score is better), ADL/IADL (scale: -3 to 3, higher score is better), and Symptoms (scale: -3 to 3, higher score is better).

    Measured: 6, 12, 24 months

  7. Health/functional status

    Measured: 6, 12, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2008 (estimated)
  2. Study startJun 2009
  3. Primary completionSep 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00790517
Sponsor's protocol ID
R18DK076775
Other IDs
R18DK076775
Acronym
STRIDE
Status last verified
Mar 2015
First submitted
12 Sep 2008
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26522674

  • 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.

    PubMed 25219423

  • 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.

    PubMed 24074269

Questions about this trial

What is this clinical trial studying?

A study testing Premier Lifestyle Intervention with DASH Diet in people with Weight Loss and Diabetes Mellitus, Type 2, run by Kaiser Permanente at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (time frame: 6, 12, 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00790517, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.

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