The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight

Burke, Lora E.; Sereika, Susan M.; Parmanto, Bambang; Beatrice, Britney; Cajita, Maan Isabella; Loar, India; Pulantara, I Wayan; Wang, Yuhan; Kariuki, Jacob K; Yu, Yang; Cedillo, Maribel; Cheng, Jessica; Conroy, Molly B.

doi:10.1016/j.cct.2020.105958

Cited by 22 publications

(24 citation statements)

References 52 publications

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“…Supporting behavior change is a key objective for DSMES programs [ 17 ]. This study was built upon self-regulation and social cognitive theory (SCT) [ 29 ] ( Figure 1 ). Self-regulation theory posits that self-monitoring aids self-evaluation of progress made toward one’s goals and aids self-reinforcement of one’s progress.…”

Section: Methodsmentioning

confidence: 99%

Community Health Worker-Led mHealth-Enabled Diabetes Self-management Education and Support Intervention in Rural Latino Adults: Single-Arm Feasibility Trial

Li¹,

Yin²,

Lesser³

et al. 2022

JMIR Diabetes

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Background Latinos living in rural South Texas have a higher prevalence of diabetes, but their access to diabetes self-management education and support (DSMES) is limited. Objective We aimed to test the feasibility of a community health worker-led, mobile health (mHealth)-based DSMES intervention to reduce disparities in accessing DSMES in underserved rural Latino residents in South Texas. Methods This 12-week, single-arm, pre-post trial was delivered by trained community health workers to 15 adults with type 2 diabetes. The intervention consisted of digital diabetes education, self-monitoring, a cloud-based connected platform, and community health worker support. Feasibility was evaluated as retention, actual intervention use, program satisfaction, and barriers to implementation. We also explored the intervention’s effect on weight loss and hemoglobin A1c (HbA1c). Results All 15 participants were Latino (mean age 61.87 years, SD 10.67; 9/15 female, 60%). The retention rate at posttest was 14 of 15 (93%). On average, the participants completed 37 of 42 (88%) digital diabetes education lessons with 8 participants completing all lessons. Participants spent 81/91 days (89%) step tracking, 71/91 days (78%) food logging, 43/91 days (47%) blood glucose self-monitoring, and 74/91 days (81%) weight self-monitoring. The level of program satisfaction was high. On average, participants lost 3.5 (SD 3.2) kg of body weight (P=.001), while HbA1c level remained unchanged from baseline (6.91%, SD 1.28%) to posttest (7.04%, SD 1.66%; P=.668). Conclusions A community health worker-led mHealth-based intervention was feasible and acceptable to improve access to DSMES services for Latino adults living in rural communities. Future randomized controlled trials are needed to test intervention efficacy on weight loss and glycemic control.

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Section: Methodsmentioning

confidence: 99%

Community Health Worker-Led mHealth-Enabled Diabetes Self-management Education and Support Intervention in Rural Latino Adults: Single-Arm Feasibility Trial

Li¹,

Yin²,

Lesser³

et al. 2022

JMIR Diabetes

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“…This study was approved by the institutional review board at the University of Pittsburgh. The study design and methods have been presented in detail elsewhere (14). The trial was registered on http://ClinicalTrials.gov (NCT03367936).…”

Section: Methodsmentioning

confidence: 99%

“…Given the preliminary efficacy findings from a pilot study (22) and the expected differences in mean percentage of weight loss at 6 and 12 months based on the results of SMART (self‐monitoring and recording with technology) trial (14), we would have 0.80 power to detect small‐to‐medium effect sizes on the mean percentage of weight changes (in terms of the standardized mean difference, d ) at 6 months between the SM and SM+FB groups as small as d = 0.301. This calculation was based on using linear contrasts from a linear mixed model at an adjusted significance level of 0.025 with a group sample size of at least 211 (or 422 total) with more needed assuming 20% attrition.…”

Section: Methodsmentioning

confidence: 99%

“…Recruitment, which was conducted from the greater community surrounding Pittsburgh, Pennsylvania, commenced in August 2018 and ended in March 2020. Inclusion criteria included BMI between 27 and 43 kg/m 2 , completion of a 5-day electronic food diary, being a regular user of a smartphone with data plan, and having the ability to engage in moderate PA. Exclusion criteria included needing medical supervision of diet or PA, pregnancy, serious mental illness, having >4 alcohol drinks per day, having binge eating disorder, and current treatment for weight loss (14).…”

Section: Setting and Participantsmentioning

confidence: 99%

“…The daily, remotely delivered FB messages enhanced adherence and improved weight loss, suggesting that technology can improve outcomes (13). These promising results, combined with advances in mobile technology, provided the foundation for expanding the FB intervention used in the current randomized clinical trial, SMARTER (14).…”

Section: Introductionmentioning

confidence: 99%

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Effect of tailored, daily feedback with lifestyle self‐monitoring on weight loss: The SMARTER randomized clinical trial

Burke

Sereika

Parmanto

et al. 2021

Obesity

Self Cite

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Objective This study aimed to test the efficacy of self‐monitoring and feedback (SM+FB) versus SM without FB (SM) in a behavioral weight‐loss intervention at 6 months. Methods This was a randomized clinical trial. Eligibility criteria included the following: ≥18 years of age, BMI ≥ 27 and ≤43, smartphone user, and ability to engage in moderate physical activity. All participants received a 90‐minute 1:1 counseling session, a Fitbit Charge 2, and a digital scale for SM. SM+FB participants were provided access to a customized smartphone application that provided three daily FB messages. The primary outcome was percentage of weight change from 0 to 6 months. Results The sample (N = 502) was 45 (SD 14.4) years old, BMI was 33.7 (SD 4.00) kg/m2, 79.5% of participants were female (n = 399), and 84.3% were White (n = 423). At 6 months, there was 85.86% retention and a significant percentage of weight change in both groups (SM+FB: −3.16%, 95% CI: −3.85% to −2.47%, p < 0.0001; SM: −3.20%, 95% CI: −3.86% to −2.54%, p < 0.0001) but no significant between‐group mean difference (−0.04%, 95% CI: −0.99% to 0.91%, p = 0.940). A ≥5% weight loss was achieved by 31.9% of the SM+FB group and 28.3% of the SM group. Conclusions There was no significant between‐group difference in weight loss at 6 months.

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Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity

Metzendorf,

Wieland,

Richter

2024

Cochrane Database of Systematic Reviews

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The SMARTER Trial: Design of a trial testing tailored mHealth feedback to impact self-monitoring of diet, physical activity, and weight

Cited by 22 publications

References 52 publications

Community Health Worker-Led mHealth-Enabled Diabetes Self-management Education and Support Intervention in Rural Latino Adults: Single-Arm Feasibility Trial

Community Health Worker-Led mHealth-Enabled Diabetes Self-management Education and Support Intervention in Rural Latino Adults: Single-Arm Feasibility Trial

Effect of tailored, daily feedback with lifestyle self‐monitoring on weight loss: The SMARTER randomized clinical trial

Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity

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