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The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults

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Scott, SE, Duarte, C, Encantado, J, Evans, EH, Harjumaa, M, Heitmann, BL, Horgan, GW, Larsen, SC, Marques, MM, Mattila, E, Matos, M, Mikkelsen, M-L, Palmeira, AL, Pearson, B, Ramsey, L, Sainsbury, K, Santos, I, Sniehotta, F, Stalker, C, Teixeira, PJ & Stubbs, RJ 2019, 'The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults' BMJ Open, bind 9, nr. 9, s. e029425. https://doi.org/10.1136/bmjopen-2019-029425

APA

CBE

Scott SE, Duarte C, Encantado J, Evans EH, Harjumaa M, Heitmann BL, Horgan GW, Larsen SC, Marques MM, Mattila E, Matos M, Mikkelsen M-L, Palmeira AL, Pearson B, Ramsey L, Sainsbury K, Santos I, Sniehotta F, Stalker C, Teixeira PJ, Stubbs RJ. 2019. The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults. BMJ Open. 9(9):e029425. https://doi.org/10.1136/bmjopen-2019-029425

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Author

Scott, Sarah Ellen ; Duarte, Cristiana ; Encantado, Jorge ; Evans, Elizabeth H ; Harjumaa, Marja ; Heitmann, Berit Lilienthal ; Horgan, Graham W ; Larsen, Sofus C ; Marques, Marta Moreira ; Mattila, Elina ; Matos, Marcela ; Mikkelsen, Marie-Louise ; Palmeira, António L ; Pearson, Beth ; Ramsey, Lauren ; Sainsbury, Kirby ; Santos, Inês ; Sniehotta, Falko ; Stalker, Carol ; Teixeira, P J ; Stubbs, R James. / The NoHoW protocol : a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults. I: BMJ Open. 2019 ; Bind 9, Nr. 9. s. e029425.

Bibtex

@article{e3c3da3198a8419cbb44475e2b35f45c,
title = "The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults",
abstract = "INTRODUCTION: Obesity and associated diseases place a severe burden on healthcare systems. Behavioural interventions for weight loss (WL) are successful in the short term but often result in weight regain over time. Self-regulation of eating and activity behaviours may significantly enhance weight loss maintenance (WLM) and may be effectively augmented by contextual behavioural approaches to emotion regulation. The NoHoW trial tests the efficacy of a theoretically informed, evidence-based digital toolkit using a mobile-enabled website, activity trackers and Wi-Fi scales for WLM aiming to target (1) self-regulation and motivation, and (2) emotion regulation in adults who achieved clinically significant (≥5{\%}) WL in the previous 12 months (initial body mass index (BMI) ≥25 kg/m2).METHODS AND ANALYSIS: The study is an 18-month, 3-centre, 2×2 factorial single-blind, randomised controlled trial, which recruited 1627 participants achieving ≥5{\%} WL between March 2017 and March 2018. Participants are randomly allocated to one of four arms: (1) self-monitoring only (self-weighing and activity tracker), (2) self-regulation and motivation, (3) emotion regulation or (4) combined self-regulation, motivation and emotion regulation. Participants attend four clinical investigation days at 0, 6, 12 and 18 months and are instructed to use the digital toolkit for 18 weeks during the first 6 months and at their discretion for the remaining 12 months. The primary outcome is change in weight (kg) at 12 months from baseline. Secondary outcomes are body composition (eg, bioimpedance analysis), health biomarkers (glycated haemoglobin, lipids, blood pressure, hair cortisol), dietary intake, physical activity, sleep, motivational, self-regulatory, emotion regulatory moderators/mediators of WLM, engagement, user experience, acceptability and cost-effectiveness of the interventions.ETHICS AND DISSEMINATION: Ethical approval was granted by Institutional Ethics Committees at the Universities of Leeds (17-0082; 27 February 2017), Lisbon (17/2016; 20 February 2017) and Capital Region of Denmark (H-16030495, 8 March 2017). Results will be published in scientific journals.TRIAL REGISTRATION NUMBER: ISRCTN88405328.",
author = "Scott, {Sarah Ellen} and Cristiana Duarte and Jorge Encantado and Evans, {Elizabeth H} and Marja Harjumaa and Heitmann, {Berit Lilienthal} and Horgan, {Graham W} and Larsen, {Sofus C} and Marques, {Marta Moreira} and Elina Mattila and Marcela Matos and Marie-Louise Mikkelsen and Palmeira, {Ant{\'o}nio L} and Beth Pearson and Lauren Ramsey and Kirby Sainsbury and In{\^e}s Santos and Falko Sniehotta and Carol Stalker and Teixeira, {P J} and Stubbs, {R James}",
note = "{\circledC} Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.",
year = "2019",
month = "9",
day = "30",
doi = "10.1136/bmjopen-2019-029425",
language = "English",
volume = "9",
pages = "e029425",
journal = "BMJ Paediatrics Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "9",

}

RIS

TY - JOUR

T1 - The NoHoW protocol

T2 - a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults

AU - Scott, Sarah Ellen

AU - Duarte, Cristiana

AU - Encantado, Jorge

AU - Evans, Elizabeth H

AU - Harjumaa, Marja

AU - Heitmann, Berit Lilienthal

AU - Horgan, Graham W

AU - Larsen, Sofus C

AU - Marques, Marta Moreira

AU - Mattila, Elina

AU - Matos, Marcela

AU - Mikkelsen, Marie-Louise

AU - Palmeira, António L

AU - Pearson, Beth

AU - Ramsey, Lauren

AU - Sainsbury, Kirby

AU - Santos, Inês

AU - Sniehotta, Falko

AU - Stalker, Carol

AU - Teixeira, P J

AU - Stubbs, R James

N1 - © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

PY - 2019/9/30

Y1 - 2019/9/30

N2 - INTRODUCTION: Obesity and associated diseases place a severe burden on healthcare systems. Behavioural interventions for weight loss (WL) are successful in the short term but often result in weight regain over time. Self-regulation of eating and activity behaviours may significantly enhance weight loss maintenance (WLM) and may be effectively augmented by contextual behavioural approaches to emotion regulation. The NoHoW trial tests the efficacy of a theoretically informed, evidence-based digital toolkit using a mobile-enabled website, activity trackers and Wi-Fi scales for WLM aiming to target (1) self-regulation and motivation, and (2) emotion regulation in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial body mass index (BMI) ≥25 kg/m2).METHODS AND ANALYSIS: The study is an 18-month, 3-centre, 2×2 factorial single-blind, randomised controlled trial, which recruited 1627 participants achieving ≥5% WL between March 2017 and March 2018. Participants are randomly allocated to one of four arms: (1) self-monitoring only (self-weighing and activity tracker), (2) self-regulation and motivation, (3) emotion regulation or (4) combined self-regulation, motivation and emotion regulation. Participants attend four clinical investigation days at 0, 6, 12 and 18 months and are instructed to use the digital toolkit for 18 weeks during the first 6 months and at their discretion for the remaining 12 months. The primary outcome is change in weight (kg) at 12 months from baseline. Secondary outcomes are body composition (eg, bioimpedance analysis), health biomarkers (glycated haemoglobin, lipids, blood pressure, hair cortisol), dietary intake, physical activity, sleep, motivational, self-regulatory, emotion regulatory moderators/mediators of WLM, engagement, user experience, acceptability and cost-effectiveness of the interventions.ETHICS AND DISSEMINATION: Ethical approval was granted by Institutional Ethics Committees at the Universities of Leeds (17-0082; 27 February 2017), Lisbon (17/2016; 20 February 2017) and Capital Region of Denmark (H-16030495, 8 March 2017). Results will be published in scientific journals.TRIAL REGISTRATION NUMBER: ISRCTN88405328.

AB - INTRODUCTION: Obesity and associated diseases place a severe burden on healthcare systems. Behavioural interventions for weight loss (WL) are successful in the short term but often result in weight regain over time. Self-regulation of eating and activity behaviours may significantly enhance weight loss maintenance (WLM) and may be effectively augmented by contextual behavioural approaches to emotion regulation. The NoHoW trial tests the efficacy of a theoretically informed, evidence-based digital toolkit using a mobile-enabled website, activity trackers and Wi-Fi scales for WLM aiming to target (1) self-regulation and motivation, and (2) emotion regulation in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial body mass index (BMI) ≥25 kg/m2).METHODS AND ANALYSIS: The study is an 18-month, 3-centre, 2×2 factorial single-blind, randomised controlled trial, which recruited 1627 participants achieving ≥5% WL between March 2017 and March 2018. Participants are randomly allocated to one of four arms: (1) self-monitoring only (self-weighing and activity tracker), (2) self-regulation and motivation, (3) emotion regulation or (4) combined self-regulation, motivation and emotion regulation. Participants attend four clinical investigation days at 0, 6, 12 and 18 months and are instructed to use the digital toolkit for 18 weeks during the first 6 months and at their discretion for the remaining 12 months. The primary outcome is change in weight (kg) at 12 months from baseline. Secondary outcomes are body composition (eg, bioimpedance analysis), health biomarkers (glycated haemoglobin, lipids, blood pressure, hair cortisol), dietary intake, physical activity, sleep, motivational, self-regulatory, emotion regulatory moderators/mediators of WLM, engagement, user experience, acceptability and cost-effectiveness of the interventions.ETHICS AND DISSEMINATION: Ethical approval was granted by Institutional Ethics Committees at the Universities of Leeds (17-0082; 27 February 2017), Lisbon (17/2016; 20 February 2017) and Capital Region of Denmark (H-16030495, 8 March 2017). Results will be published in scientific journals.TRIAL REGISTRATION NUMBER: ISRCTN88405328.

U2 - 10.1136/bmjopen-2019-029425

DO - 10.1136/bmjopen-2019-029425

M3 - Journal article

VL - 9

SP - e029425

JO - BMJ Paediatrics Open

JF - BMJ Paediatrics Open

SN - 2044-6055

IS - 9

ER -

ID: 58098269