Lifestyle Intervention and Excess Weight in COPD: INSIGHT COPD Randomized Clinical Trial.

Rationale Being overweight or obese is common among patients with chronic obstructive pulmonary disease (COPD), but whether interventions targeted at weight loss improve functional impairments is unknown. Objectives INSIGHT tested whether a pragmatic low-intensity lifestyle intervention would lead to better physical functional status among participants with overweight or obesity and COPD. Methods The trial was a 12-month, multicentered, patient-level pragmatic clinical trial. Participants were recruited from April 2017 to August 2019 from 38 sites across the U.S. and randomized to either usual care or usual care plus lifestyle intervention. The intervention was a self-directed video program delivering the Diabetes Prevention Program's Group Lifestyle Balance curriculum. Results The primary outcome was six-minute walk test (6MWT) distance at 12 months. Priority secondary outcomes were post-walk modified Borg dyspnea at 12 months and weight at 12 months. Participants (N=684; mean 67.0 [SD 8.0] years, 41.2% female) on average were obese (BMI, 33.0 [SD 4.6] kg/m2) with moderate COPD (FEV1% predicted, 58.1% [SD 15.7%]). At 12 months, participants randomized to the intervention walked farther (adjusted difference, 42.3 ft [95%CI: 7.9, 76.7]; P=0.02), had less dyspnea at end of the 6MWT (adjusted difference, -0.36 [95%CI: -0.63, -0.09]; P=0.008) and greater weight loss (adjusted difference, -1.34 kg [95%CI: -2.33, -0.34]; P=0.008) than controls. The intervention did not improve the odds of achieving clinically meaningful thresholds of walk distance (98.4 ft) or dyspnea (1 unit) but did achieve meaningful thresholds of weight loss (3 and 5% weight loss). Conclusions Among participants with COPD who were overweight or obese, a self-guided low intensity video-based lifestyle intervention led to modest weight loss but did not lead to clinically important improvements in physical functional status and dyspnea. Clinical Trial Registration ClinicalTrials.gov; Registration number NCT02634268 Primary Source of Funding Supported by 1U01HL128868 (NIH/NHBLI) and the Network Management Core for the Pulmonary Trials Cooperative (NIH/NHLBI U01HL128954).