Recruiting

Telehealth Intervention

Sponsor:

Seattle Institute for Biomedical and Clinical Research

Code:

NCT06390345

Conditions

Chronic Obstructive Pulmonary Disease

Obstructive Sleep Apnea

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FOCuSEd Integrated Intervention

Enhanced Usual Care

Study Details

Brief summary:

The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. The investigators will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. < 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework.

Conditions

Chronic Obstructive Pulmonary Disease

Obstructive Sleep Apnea

Overweight and Obesity

Study ID

NCT06390345

Start date

Jul 29, 2024

Status verified date

Jul, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • COPD: Defined by presence of airflow obstruction (FEV1/FVC < 0.70) on post-bronchodilator spirometry
  • ≥10 pack year history of tobacco use
  • Self-reported clinician diagnosis of OSA (or presence of OSA on research HSAT)
  • BMI ≥ 25 kg/m2
  • Symptoms of dyspnea defined by MMRC score of ≥1

Exclusion Criteria:

  • Self-report of weight change >15 lbs. during prior 3 months
  • Current active weight loss treatment, including: 1) research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS, MOVE!); 2) other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) in the local community; 3) prescription weight loss medication within last 3 months; and scheduled bariatric surgery.
  • Severe illness from any cause
  • Diagnosis of bulimia or history of purging behavior
  • Active enrollment in pulmonary rehabilitation
  • Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy < 12 months. These include but may not be limited to: unstable cardiac arrhythmias, active or recent (within one month) myocardial infarction, active or recent (within one month) COPD exacerbation, angina not well-controlled with medication, significant musculoskeletal comorbidities or physical infirmities that preclude participation in an exercise program, and the need for supplemental oxygen ≥ 5 lpm at rest or with exertion.
  • Pregnant, lactating, or planning to become pregnant during the study period
  • Participation in other intervention studies.
  • Prisoner
  • Unable to complete surveys in English

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: FOCuSEd Intervention

Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation.

active comparator: Usual Care- Enhanced

For participants in the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs.

Interventions

FOCuSEd Integrated Intervention

Participants randomized to the intervention will receive an integrated telehealth-delivered, remote lifestyle intervention that promotes healthy eating and 150 minutes per week of moderate-intensity physical exercise. This intervention will include a "core curriculum" during the first 3 months that includes: 1) a 12-session video based program; 2) goal setting and self-monitoring using a Fitbit tracker and MyFitnessPal; 3) lifestyle coaching; and 4) three tele-pulmonary rehab sessions and an additional 60-75 minutes of gradually increasing self-directed exercise per week. At the end of 3 months, we will offer to enter a recommendation for weight loss medications to intervention participants with a BMI of ≥ 27 kg/m2. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach.

Enhanced Usual Care

Participants in the "enhanced" usual care group will be referred to MOVE! (VA's weight loss management program) and pulmonary rehabilitation in coordination with their primary care provider.

Primary outcome measure

  • The SF-12 PCS [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Brianna Moss

206.277.4166brianna.moss@va.gov

Locations

Boise VA Medical Center

Recruiting

Boise, Idaho, United States, 83702

Contacts

Brianna Moss

brianna.moss@va.gov

Principal Investigator:

Paula Carvalho, MD

Jesse Brown VA Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Brianna Moss

brianna.moss@va.gov

Principal Investigator:

Min Joo, MD

Minneapolis VA Health Care System

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Brianna Moss

brianna.moss@va.gov

Principal Investigator:

Charles Billington, MD

VA Puget Sound Health Care System

Recruiting

Seattle, Washington, United States, 98108

Contacts

Brianna Moss

206.277.4166brianna.moss@va.gov

Principal Investigator:

Laura C Feemster, MD MS

Mann-Grandstaff VA Medical Center

Recruiting

Spokane, Washington, United States, 99205

Contacts

Brianna Moss

206-277-4166brianna.moss@va.gov

Principal Investigator:

Allison A Lambert, MD

More Information

Sponsor

Seattle Institute for Biomedical and Clinical Research

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Seattle Institute for Biomedical and Clinical Research on 2026-07-22.