No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Seattle Institute for Biomedical and Clinical Research · Other
Who this trial is looking for
This trial is looking for overweight or obese patients who have Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA). If you participate, you will receive a telehealth program that includes lifestyle coaching and exercise guidance over 12 months.
Are You a Good Fit for This Trial?
Rules you outSevere illnessBulimiaActive pulmonary rehabilitation
You may be able to join if
I have been diagnosed with COPD.
I have a history of smoking.
I have been diagnosed with OSA.
I have a body mass index (BMI) of 25 or higher.
I have some difficulty breathing.
You may not be able to join if
I have lost more than 15 lbs in the last 3 months.
I am currently on any weight loss program or medication.
I have a severe illness of any kind.
I have a diagnosis of bulimia or a history of purging.
I am currently enrolled in pulmonary rehabilitation.
I am pregnant, breastfeeding, or planning to become pregnant.
I am unable to complete surveys in English.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
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 …
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
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