Effect of a Remotely Delivered Self-directed Behavioral Intervention on Body Weight and Physical Health Status Among Adults With Obesity: The D-ELITE Randomized Clinical Trial

被引:15
|
作者
Hoerster, Katherine D. [1 ,2 ,3 ]
Hunter-Merrill, Rachel [1 ]
Nguyen, Tanya [1 ]
Rise, Peter [1 ]
Baron, Anna E. [4 ]
McDowell, Jennifer [1 ]
Donovan, Lucas M. [1 ,5 ]
Gleason, Emily [1 ]
Lane, Amber [1 ]
Plumley, Robert [1 ]
Schooler, Mary [1 ]
Schuttner, Linnaea [1 ,6 ]
Collins, Margaret [1 ]
Au, David H. [1 ,6 ]
Ma, Jun [7 ]
机构
[1] VA Puget Sound Healthcare Syst, Seattle Div, Hlth Serv Res & Dev, Seattle, WA 98108 USA
[2] VA Puget Sound Healthcare Syst, Seattle Div, Mental Hlth Serv, Seattle, WA 98108 USA
[3] Univ Washington, Dept Psychiat & Behav Sci, Seattle, WA 98195 USA
[4] Univ Colorado, Dept Biostat & Informat, Colorado Sch Publ Hlth, Anschutz Med Campus, Aurora, CO USA
[5] Univ Washington, Div Pulm Crit Care & Sleep Med, Seattle, WA USA
[6] Univ Washington, Dept Med, Seattle, WA USA
[7] Univ Illinois, Dept Med, Chicago, IL USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2022年 / 328卷 / 22期
关键词
QUALITY-OF-LIFE; RELIABILITY;
D O I
10.1001/jama.2022.21177
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Importance The effectiveness of remotely delivered, self-directed, weight loss programs in routine clinical practice is largely unknown. Objective To test whether a self-directed, remotely administered behavioral lifestyle intervention improves weight and self-reported general health status compared with usual care. Design, Setting, and Participants In this randomized clinical trial, 511 adults with a body mass index (BMI) of 30 or more and less than 45 (based on electronic health record [EHR] weight and height), were enrolled from 30 Veterans Health Administration (VHA) sites between February 15, 2018, and December 18, 2018 (final follow-up February 18, 2021). InterventionsParticipants were randomly assigned to the intervention group (n=254) or the control group (n=257). Both received usual care. Participants randomized to the intervention received Diabetes Prevention Program-based self-directed videos, handouts, and coaching messages via an online platform or US mail for 12 months. Main Outcomes and Measures Coprimary outcomes were weight measured in primary care and recorded in the EHR and self-reported general health status using the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) physical component score (PCS; higher scores are better [range, 0-100]) at the 12-month follow-up. The between-group minimal clinically important differences are 3 kg for weight and 5 points for the SF-12 PCS. Linear mixed models used weights and SF-12 PCS measured at either time point, with participants analyzed according to randomization assignment. Statistical significance for each coprimary outcome was based on a 2-sided alpha level of .025. Results Among 511 participants randomized (mean age, 57.4 [SD, 13.9] years; 231 female [45%]), 429 (84.0%) had EHR-based weights and 410 (80.2%) had SF-12 PCS data at 12 months. The unadjusted mean weight at 12 months declined from 102.7 kg to 99.8 kg in the intervention group compared with 101.9 kg to 101.0 kg in the control group (adjusted between-group mean difference, -1.93 [97.5% CI, -3.24 to -0.61]; P=.001). At 12 months, the unadjusted mean SF-12 PCS scores declined from 44.8 to 44.3 among intervention participants compared with 44.5 to 43.2 among control participants (adjusted between-group mean difference, intervention minus control, 0.69 [97.5% CI, -1.11 to 2.49]; P=.39). Cardiovascular events represented the highest percentage of serious adverse events, accounting for 25% of events in the intervention group and 35% in the control group. Conclusions and Relevance Among adults with obesity, a remotely delivered self-directed, behavioral lifestyle intervention, compared with usual care, resulted in statistically significantly greater weight loss at 12 months, although the difference was not clinically important. There was no significant difference in self-reported general physical health status at 12 months. Trial RegistrationClinicalTrials.gov Identifier: NCT03260140
引用
收藏
页码:2230 / 2241
页数:12
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