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Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.

ABSTRACT: Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.

SUBMITTER: Hoerster KD

PROVIDER: S-EPMC7253950 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.

Hoerster Katherine D KD Collins Margaret P MP Au David H DH Lane Amber A Epler Eric E McDowell Jennifer J Barón Anna E AE Rise Peter P Plumley Robert R Nguyen Tanya T Schooler Mary M Schuttner Linnaea L Ma Jun J

Contemporary clinical trials 20200528

Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention ...[more]

PMID: 32473403

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Project description:ImportanceThe effectiveness of remotely delivered, self-directed, weight loss programs in routine clinical practice is largely unknown.ObjectiveTo 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 participantsIn 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 measuresCoprimary 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 α level of .025.ResultsAmong 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 relevanceAmong 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.

Project description:ObjectiveScalable, efficiently delivered treatments are needed to address the needs of women Veterans with PTSD. This randomized clinical trial compared an online, coach-assisted cognitive behavioral intervention tailored for women Veterans with PTSD to phone monitoring only.MethodWomen Veterans who met diagnostic criteria for PTSD were randomized to an 8-week web-based intervention, called DElivery of Self TRaining and Education for Stressful Situations (DESTRESS)-Women Veterans version (WV), or to phone monitoring only (N = 102). DESTRESS-WV consisted of online sessions and 15-min weekly phone calls from a study coach. Phone monitoring included 15-min weekly phone calls from a study coach to offer general support. PTSD symptom severity (PTSD Symptom-Checklist-Version 5 [PCL-5]) was evaluated pre and posttreatment, and at 3 and 6 months posttreatment.ResultsMore participants completed phone monitoring than DESTRESS-WV (96% vs. 76%, p = 0.01), although treatment satisfaction was significantly greater in the DESTRESS-WV condition. We failed to confirm the superiority of DESTRESS-WV in intent-to-treat slope changes in PTSD symptom severity. Both treatments were associated with significant reductions in PTSD symptom severity over time. However, post hoc analyses of treatment completers and of those with baseline PCL ≥ 33 revealed that the DESTRESS-WV group had greater improvement in PTSD symptom severity relative to phone monitoring with significant differences at the 3-month follow-up assessment.ConclusionsBoth DESTRESS-WV and phone monitoring resulted in significant improvements in women Veterans' PTSD symptoms. DESTRESS-WV may be an appropriate care model for women Veterans who can engage in the demands of the treatment and have higher baseline symptoms. Future research should explore characteristics of and the methods of reliably identifying women Veterans who are most likely to benefit. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Dataset Information

Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.

Publications

Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.

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