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. 2024 Nov:231:45-54.
doi: 10.1016/j.ymeth.2024.09.009. Epub 2024 Sep 13.

Digital Intervention for behaviouR changE and Chronic disease prevenTION (DIRECTION): Study protocol for a randomized controlled trial of a web-based platform integrating nutrition, physical activity, and mindfulness for individuals with obesity

Camila E Orsso  1 , Teresita Gormaz  2 , Sabina Valentine  3 , Claire F Trottier  4 , Iasmin Matias de Sousa  5 , Martin Ferguson-Pell  6 , Steven T Johnson  7 , Amy A Kirkham  8 , Douglas Klein  9 , Nathanial Maeda  10 , João F Mota  11 , Sarah E Neil-Sztramko  12 , Maira Quintanilha  13 , Bukola Oladunni Salami  14 , Carla M Prado  15
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Free article

Digital Intervention for behaviouR changE and Chronic disease prevenTION (DIRECTION): Study protocol for a randomized controlled trial of a web-based platform integrating nutrition, physical activity, and mindfulness for individuals with obesity

Camila E Orsso et al. Methods. 2024 Nov.
Free article

Abstract

Excess body weight, suboptimal diet, physical inactivity, alcohol consumption, sleep disruption, and elevated stress are modifiable risk factors associated with the development of chronic diseases. Digital behavioural interventions targeting these factors have shown promise in improving health and reducing chronic disease risk. The Digital Intervention for behaviouR changE and Chronic disease prevenTION (DIRECTION) study is a parallel group, two-arm, randomized controlled trial evaluating the effects of adding healthcare professional guidance and peer support via group-based sessions to a web-based wellness platform (experimental group, n = 90) compared to a self-guided use of the platform (active control group, n = 90) among individuals with a body mass index (BMI) of 30 to <35 kg/m2 and aged 40-65 years. Obesity is defined by a high BMI. The web-based wellness platform employed in this study is My Viva Plan (MVP)®, which holistically integrates nutrition, physical activity, and mindfulness programs. Over 16 weeks, the experimental group uses the web-based wellness platform daily and engages in weekly online support group sessions. The active control group exclusively uses the web-based wellness platform daily. Assessments are conducted at baseline and weeks 8 and 16. The primary outcome is between-group difference in weight loss (kg) at week 16, and secondary outcomes are BMI, percent weight change, proportion of participants achieving 5% or more weight loss, dietary intake, physical activity, alcohol consumption, sleep, and stress across the study. A web-based wellness platform may be a scalable approach to promote behavioural changes that positively impact health. This study will inform the development and implementation of interventions using web-based wellness platforms and personalized digital interventions to improve health outcomes and reduce chronic disease risk among individuals with obesity.

Keywords: Behavioural change; Chronic disease prevention; Digital health platform; Obesity intervention; Weight loss.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: CMP has previously received honoraria and/or paid consultancy from Almased. NM has since become an employee of My Viva Plan. CEO, TG, SV, CFT, IMS, MFP, STJ, AAK, DK, NM, JFM, SENS, MQ, BOS – no conflicts of interest. See Funding section above for additional competing interests.

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