Objectives Most electronically delivered lifestyle interventions are labor intensive, requiring logging onto websites and manually recording activity and diet. Cumbersome technology and lack of a human coach may have contributed to the limitations of prior interventions. In response, the current program of research created a comprehensive electronically delivered lifestyle intervention using a user‐friendly, interactive, smartphone app‐based model, and evaluated it in a randomized controlled trial. Methods Twenty‐eight adults, body mass index 25–42 kg/m2, with smartphones and sedentary jobs, were randomized to the intervention, along with conventional outpatient weight‐management visits every 3 months, or to a wait‐listed control group that received only weight‐management visits. The intervention included wearable activity trackers, smartscales, food photography logs, physician‐driven app‐based behavioral coaching, and peer support via the app. The prespecified primary outcome was a comparison of change in weight in kilograms, in the intervention versus control group at 6 months. Results At 6 months, the intervention group experienced a statistically significant weight change of −7.16 ± 1.78 kg (mean ± SE, 95% CI −11.05 to −3.26, p < 0.01), which differed from the weight change in controls by −4.16 ± 2.01 kg (95% CI −8.29 to −0.02, p < 0.05, prespecified primary outcome). Weight change in the control group was −3.00 ± 1.05 kg (95% CI −5.27 to −0.73, p < 0.05). Waist circumference and hemoglobin A1c significantly improved (intervention vs. control: p < 0.01, p < 0.05, respectively, prespecified secondary outcomes). Weight change in the intervention group correlated with numbers of food photographs participants shared (rho = −0.86, p < 0.01), numbers of their text messages (rho = −0.80, p < 0.01), number of times and days each participant stepped on the smartscale (rho = −0.73, p < 0.01; rho = −0.608, p < 0.05, respectively), and mean daily step counts (rho = −0.55, p < 0.05). Conclusion This app‐based electronically delivered lifestyle intervention produced statistically significant, clinically meaningful weight loss and improved metabolic health. Engagement with the intervention correlated strongly with weight loss. Given the limited sample size, larger and longer studies of this intervention are needed.
Despite widespread use of smartphones and wearables, we have limited evidence that they aid weight loss or lifestyle. Here, we report results of a 6-month RCT of our smartphone app-based lifestyle intervention vs. standard of care (in-person weight management visits at 0, 3, and 6 months) in a cohort of overweight or obese subjects. The app downloads objective data of daily weights from smartscales and physical activity from 3-axis accelerometers. The technology allows peer social networking and remote professional coaching employing behavior modification techniques delivered via group and private messaging, emoticons, shared activity and weight data, shared photographs of meals, and a virtual reward system for behavior modification. Intervention group: n=13, 85% F, age 39.5 ± 3.71 y, initial weight 94.3 ± 3.42 kg, BMI 34.5 ± 1.3 kg/m2. Control group: n=15, 86% F, age 45.1 ± 3.31 y, initial weight 92.3 ± 4.37 kg, BMI 33.8 ± 1.kg/m2 (means ± SE). We found a clinically and statistically significant weight difference of -4.2 ± 2.0 kg (95% CI -8.3 to -0.02 p=0.0488) after 6 months of our smartphone app-based lifestyle intervention (prespecified primary outcome, intervention vs. control). In the intervention group, weight change was -7.2 ± 1.8 kg (95% CI -11.1 to -3.3, p = 0.0017); % weight change was -7.9% ± 2.2% (95% CI -12.6 to -3.2, p=0.0031). Weight change significantly associated with median step counts (Pearson’s correlation coefficient r=-0.61, p=0.027), numbers of text messages from each subject (r=-0.83, p=0.0005), and numbers of diet photos shared (r =-0.83 p=0.0005). Our app-based lifestyle intervention met the prespecified primary outcome of clinically meaningful and statistically significant weight loss at 6 months over control. The strongest correlations with weight loss in the intervention group were physical activity (step counts) and subjects’ engagement in behavior modification coaching (messages and diet photos). Disclosure C. Vaz: None. A.G. Suthar: None. B.T. Pousti: None. S.M. Aye: None. K. Williams: Stock/Shareholder; Self; Hygieia, Gemphire, Inc.. Advisory Panel; Self; Gemphire, Inc.. H. Zhao: None.
Hospital readmission within 30 days of discharge (30dRe) is a high-priority quality measure and target for cost reduction. Patients with diabetes are at higher risk of 30dRe than patients without diabetes. There have been no published studies of interventions designed to reduce 30dRe risk specifically among diabetes patients. We conducted a pilot randomized controlled trial (RCT) of the DiaTOHC intervention in adult patients with diabetes admitted to any medical-surgical unit at Temple University Hospital between 10/2017 and 12/2018. Patients predicted to be high risk (>=27%) for 30dRe based on a validated tool (DERRITM) were randomized 1:1 to the intervention (INT) or usual care (UC). The intervention consisted of novel, brief inpatient diabetes education, coordination of care, and post-discharge support by a nurse practitioner and an A1C-based algorithm to adjust diabetes therapy. Patients received weekly calls for 30 days after discharge. The primary outcome was unplanned 30dRe. Follow-up data was available for 26 INT and 30 UC patients. Mean age was 57.5 years, duration of diabetes 17 years, and median admission A1C 7.9%. The cohort was 75% black, 20% white, 13% Hispanic, 55% female, mostly low-income, and mostly insured by Medicare and/or Medicaid. Most patients (95%) had type 2 diabetes. There were few baseline differences between groups, including years of school (13.5 INT, 11.9 UC, p=0.03) and preadmission insulin use (59.6% INT, 40.4% UC, p<0.01). Six INT and 10 UC patients had a 30dRe (23.1%, 33.3%, P=0.40), yielding a non-significant relative risk reduction of 30.6%, absolute risk reduction of 10.2% and number needed to treat of 10. Median A1C at 3 months among the 18 patients with data was 6.7% INT and 8.4% UC, p=0.19. This small pilot trial shows the DiaTOHC intervention is feasible. The non-significant but measurable reductions in readmission risk and A1C merit further investigation in a larger RCT. Disclosure D.J. Rubin: Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. S. Golden: Research Support; Self; Merck & Co., Inc. G. Foster: Employee; Self; Weight Watchers International, Inc. S. Fisher: None. C. Vaz: None. H. Zhao: None. S. Tanner: None. D. Recco: None. M. Tivon: None. F.R. Dillard: None. S. Watts: None. K.E. Joyce: None. A. Karunakaran: None. T. Reznick: None. A. Iwamaye: None. E. Miller: None. C. Mathai: None. B.S. Albury: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (K23DK102963 to D.J.R.)
Unplanned hospital readmission is a high-priority quality measure and target for cost reduction. Patients with diabetes are at higher risk of readmission than patients without diabetes. We previously presented results of a pilot randomized controlled trial (RCT) of an intervention designed to reduce readmission risk (the Diabetes Transition of Hospital Care [DiaTOHC] program) with outcomes assessed 30 days after hospital discharge. Here we present secondary outcomes assessed 90 days after discharge. Patients predicted to be high risk (>=27%) for readmission based on a validated readmission risk tool (DERRITM) were randomized 1:1 to the intervention (INT) or usual care (UC). The intervention consisted of inpatient diabetes education, coordination of care, post-discharge support by a nurse practitioner, adjustment of diabetes therapy, and weekly phone calls for 30 days after discharge. There were 45 INT and 46 UC patients randomized and analyzed by intention-to-treat. Twenty-one INT and 23 UC patients had a readmission (46.7% vs. 50%) while 25 INT and 27 UC patients had a readmission or Emergency Department (ED) visit (55.6% vs. 58.7%). The ratio of the mean estimated cost of readmissions, ED visits, and the intervention in the INT group was 0.51 (0.25-1.02)95%CL the cost of readmissions and ED visits in the UC group. Among the 69 patients with an admission A1C >7%, 14 INT and 17 UC patients had a readmission (41.2% vs. 48.6%), and 18 INT and 21 UC patients had a readmission or ED visit (52.9% vs. 60.0%), yielding relative risk reductions of 15.2% and 11.8%. The INT:UC group ratio of the mean estimated cost was 0.50 (0.22-1.12)95%CL. No differences were statistically significant in this pilot study. The DiaTOHC intervention may modestly reduce readmission risk and cut costs by half within 90 days after discharge among patients with an admission A1C >7%. This merits further investigation in a larger RCT. Disclosure D.J. Rubin: None. S. Watts: None. A. Deak: None. C. Vaz: None. S. Tanner: None. D. Recco: None. M. Tivon: None. F.R. Dillard: None. E. Brzana: None. K.E. Joyce: None. A. Karunakaran: None. A. Iwamaye: None. E. Miller: None. C. Mathai: None. N. Kondamuri: None. B.S. Albury: None. S. Allen: None. M.D. Naylor: None. S. Golden: None. J. Wu: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (K23DK102963)
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