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A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial

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A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes : Randomized Controlled Trial. / Staite, Emily; Bayley, Adam; Al-Ozairi, Ebaa; Stewart, Kurtis; Hopkins, David; Rundle, Jennifer; Basudev, Neel; Mohamedali, Zahra; Ismail, Khalida.

In: JMIR mHealth and uHealth, Vol. 8, No. 7, e15448, 15.07.2020, p. e15448.

Research output: Contribution to journalArticle

Harvard

Staite, E, Bayley, A, Al-Ozairi, E, Stewart, K, Hopkins, D, Rundle, J, Basudev, N, Mohamedali, Z & Ismail, K 2020, 'A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial', JMIR mHealth and uHealth, vol. 8, no. 7, e15448, pp. e15448. https://doi.org/10.2196/15448

APA

Staite, E., Bayley, A., Al-Ozairi, E., Stewart, K., Hopkins, D., Rundle, J., Basudev, N., Mohamedali, Z., & Ismail, K. (2020). A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial. JMIR mHealth and uHealth, 8(7), e15448. [e15448]. https://doi.org/10.2196/15448

Vancouver

Staite E, Bayley A, Al-Ozairi E, Stewart K, Hopkins D, Rundle J et al. A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial. JMIR mHealth and uHealth. 2020 Jul 15;8(7):e15448. e15448. https://doi.org/10.2196/15448

Author

Staite, Emily ; Bayley, Adam ; Al-Ozairi, Ebaa ; Stewart, Kurtis ; Hopkins, David ; Rundle, Jennifer ; Basudev, Neel ; Mohamedali, Zahra ; Ismail, Khalida. / A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes : Randomized Controlled Trial. In: JMIR mHealth and uHealth. 2020 ; Vol. 8, No. 7. pp. e15448.

Bibtex Download

@article{e29a0eebd40b4bdfb79dd08c0b727168,
title = "A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial",
abstract = "Background: Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective: This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods: We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A 1c (HbA 1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA 1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results: We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions: This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. ",
keywords = "diabetes prevention program, lifestyle, mobile phone, motivational interviewing, theory of planned behavior, type 2 diabetes mellitus, wearable technology",
author = "Emily Staite and Adam Bayley and Ebaa Al-Ozairi and Kurtis Stewart and David Hopkins and Jennifer Rundle and Neel Basudev and Zahra Mohamedali and Khalida Ismail",
year = "2020",
month = jul,
day = "15",
doi = "10.2196/15448",
language = "English",
volume = "8",
pages = "e15448",
journal = "JMIR mHealth and uHealth",
issn = "2291-5222",
publisher = "Journal of medical Internet Research",
number = "7",

}

RIS (suitable for import to EndNote) Download

TY - JOUR

T1 - A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes

T2 - Randomized Controlled Trial

AU - Staite, Emily

AU - Bayley, Adam

AU - Al-Ozairi, Ebaa

AU - Stewart, Kurtis

AU - Hopkins, David

AU - Rundle, Jennifer

AU - Basudev, Neel

AU - Mohamedali, Zahra

AU - Ismail, Khalida

PY - 2020/7/15

Y1 - 2020/7/15

N2 - Background: Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective: This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods: We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A 1c (HbA 1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA 1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results: We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions: This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP.

AB - Background: Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective: This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods: We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A 1c (HbA 1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA 1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results: We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions: This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP.

KW - diabetes prevention program

KW - lifestyle

KW - mobile phone

KW - motivational interviewing

KW - theory of planned behavior

KW - type 2 diabetes mellitus

KW - wearable technology

UR - http://www.scopus.com/inward/record.url?scp=85088252988&partnerID=8YFLogxK

U2 - 10.2196/15448

DO - 10.2196/15448

M3 - Article

C2 - 32459651

AN - SCOPUS:85088252988

VL - 8

SP - e15448

JO - JMIR mHealth and uHealth

JF - JMIR mHealth and uHealth

SN - 2291-5222

IS - 7

M1 - e15448

ER -

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