Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity

a randomised controlled trial in the UK (NULevel Trial)

Falko F. Sniehotta, Elizabeth H. Evans, Kirby Sainsbury, Ashley Adamson, Alan Batterham, Frauke Becker, Heather Brown, Stephan U. Dombrowski, Dan Jackson, Denise Howell, Karim Ladha, Elaine McColl, Patrick Olivier, Alexander J. Rothman, Alison Steel, Luke Vale, Rute Vieira, Martin White, Peter Wright, Vera Araújo-Soares

Research output: Contribution to journalArticleResearchpeer-review

Abstract

BACKGROUND: Scalable weight loss maintenance (WLM) interventions for adults with obesity are lacking but vital for the health and economic benefits of weight loss to be fully realised. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss (≥5%) compared to standard lifestyle advice. METHODS AND FINDINGS: The NULevel trial was an open-label randomised controlled superiority trial in 288 adults recruited April 2014 to May 2015 with weight loss of ≥5% within the previous 12 months, from a pre-weight loss BMI of ≥30 kg/m2. Participants were self-selected, and the majority self-certified previous weight loss. We used a web-based randomisation system to assign participants to either standard lifestyle advice via newsletter (control arm) or a technology-mediated low-intensity behavioural WLM programme (intervention arm). The intervention comprised a single face-to-face goal-setting meeting, self-monitoring, and remote feedback on weight, diet, and physical activity via links embedded in short message service (SMS). All participants were provided with wirelessly connected weighing scales, but only participants in the intervention arm were instructed to weigh themselves daily and told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as frequency of self-weighing, objective physical activity (via accelerometry), psychological variables, and cost-effectiveness. The study was powered to detect a between-group weight difference of ±2.5 kg at follow-up. Overall, 264 participants (92%) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95% CI 0.5-3.1) in the intervention group (n = 131) and 1.8 kg (95% CI 0.6-3.0) in the control group (n = 133). There was no evidence of an effect on weight at 12 months (difference in adjusted mean weight change from baseline: -0.07 [95% CI 1.7 to -1.9], p = 0.9). Intervention participants weighed themselves more frequently than control participants and were more physically active. Intervention participants reported greater satisfaction with weight outcomes, more planning for dietary and physical activity goals and for managing lapses, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed. CONCLUSIONS: There was no difference in the WLM of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter. The intervention affected some, but not all, process-related secondary outcomes of the trial. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

Original languageEnglish
Number of pages18
JournalPLoS Medicine
Volume16
Issue number5
DOIs
Publication statusPublished - 7 May 2019
Externally publishedYes

Cite this

Sniehotta, Falko F. ; Evans, Elizabeth H. ; Sainsbury, Kirby ; Adamson, Ashley ; Batterham, Alan ; Becker, Frauke ; Brown, Heather ; Dombrowski, Stephan U. ; Jackson, Dan ; Howell, Denise ; Ladha, Karim ; McColl, Elaine ; Olivier, Patrick ; Rothman, Alexander J. ; Steel, Alison ; Vale, Luke ; Vieira, Rute ; White, Martin ; Wright, Peter ; Araújo-Soares, Vera. / Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity : a randomised controlled trial in the UK (NULevel Trial). In: PLoS Medicine. 2019 ; Vol. 16, No. 5.
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title = "Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity: a randomised controlled trial in the UK (NULevel Trial)",
abstract = "BACKGROUND: Scalable weight loss maintenance (WLM) interventions for adults with obesity are lacking but vital for the health and economic benefits of weight loss to be fully realised. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss (≥5{\%}) compared to standard lifestyle advice. METHODS AND FINDINGS: The NULevel trial was an open-label randomised controlled superiority trial in 288 adults recruited April 2014 to May 2015 with weight loss of ≥5{\%} within the previous 12 months, from a pre-weight loss BMI of ≥30 kg/m2. Participants were self-selected, and the majority self-certified previous weight loss. We used a web-based randomisation system to assign participants to either standard lifestyle advice via newsletter (control arm) or a technology-mediated low-intensity behavioural WLM programme (intervention arm). The intervention comprised a single face-to-face goal-setting meeting, self-monitoring, and remote feedback on weight, diet, and physical activity via links embedded in short message service (SMS). All participants were provided with wirelessly connected weighing scales, but only participants in the intervention arm were instructed to weigh themselves daily and told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as frequency of self-weighing, objective physical activity (via accelerometry), psychological variables, and cost-effectiveness. The study was powered to detect a between-group weight difference of ±2.5 kg at follow-up. Overall, 264 participants (92{\%}) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95{\%} CI 0.5-3.1) in the intervention group (n = 131) and 1.8 kg (95{\%} CI 0.6-3.0) in the control group (n = 133). There was no evidence of an effect on weight at 12 months (difference in adjusted mean weight change from baseline: -0.07 [95{\%} CI 1.7 to -1.9], p = 0.9). Intervention participants weighed themselves more frequently than control participants and were more physically active. Intervention participants reported greater satisfaction with weight outcomes, more planning for dietary and physical activity goals and for managing lapses, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed. CONCLUSIONS: There was no difference in the WLM of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter. The intervention affected some, but not all, process-related secondary outcomes of the trial. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).",
author = "Sniehotta, {Falko F.} and Evans, {Elizabeth H.} and Kirby Sainsbury and Ashley Adamson and Alan Batterham and Frauke Becker and Heather Brown and Dombrowski, {Stephan U.} and Dan Jackson and Denise Howell and Karim Ladha and Elaine McColl and Patrick Olivier and Rothman, {Alexander J.} and Alison Steel and Luke Vale and Rute Vieira and Martin White and Peter Wright and Vera Ara{\'u}jo-Soares",
year = "2019",
month = "5",
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doi = "10.1371/journal.pmed.1002793",
language = "English",
volume = "16",
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Sniehotta, FF, Evans, EH, Sainsbury, K, Adamson, A, Batterham, A, Becker, F, Brown, H, Dombrowski, SU, Jackson, D, Howell, D, Ladha, K, McColl, E, Olivier, P, Rothman, AJ, Steel, A, Vale, L, Vieira, R, White, M, Wright, P & Araújo-Soares, V 2019, 'Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity: a randomised controlled trial in the UK (NULevel Trial)', PLoS Medicine, vol. 16, no. 5. https://doi.org/10.1371/journal.pmed.1002793

Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity : a randomised controlled trial in the UK (NULevel Trial). / Sniehotta, Falko F.; Evans, Elizabeth H.; Sainsbury, Kirby; Adamson, Ashley; Batterham, Alan; Becker, Frauke; Brown, Heather; Dombrowski, Stephan U.; Jackson, Dan; Howell, Denise; Ladha, Karim; McColl, Elaine; Olivier, Patrick; Rothman, Alexander J.; Steel, Alison; Vale, Luke; Vieira, Rute; White, Martin; Wright, Peter; Araújo-Soares, Vera.

In: PLoS Medicine, Vol. 16, No. 5, 07.05.2019.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity

T2 - a randomised controlled trial in the UK (NULevel Trial)

AU - Sniehotta, Falko F.

AU - Evans, Elizabeth H.

AU - Sainsbury, Kirby

AU - Adamson, Ashley

AU - Batterham, Alan

AU - Becker, Frauke

AU - Brown, Heather

AU - Dombrowski, Stephan U.

AU - Jackson, Dan

AU - Howell, Denise

AU - Ladha, Karim

AU - McColl, Elaine

AU - Olivier, Patrick

AU - Rothman, Alexander J.

AU - Steel, Alison

AU - Vale, Luke

AU - Vieira, Rute

AU - White, Martin

AU - Wright, Peter

AU - Araújo-Soares, Vera

PY - 2019/5/7

Y1 - 2019/5/7

N2 - BACKGROUND: Scalable weight loss maintenance (WLM) interventions for adults with obesity are lacking but vital for the health and economic benefits of weight loss to be fully realised. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss (≥5%) compared to standard lifestyle advice. METHODS AND FINDINGS: The NULevel trial was an open-label randomised controlled superiority trial in 288 adults recruited April 2014 to May 2015 with weight loss of ≥5% within the previous 12 months, from a pre-weight loss BMI of ≥30 kg/m2. Participants were self-selected, and the majority self-certified previous weight loss. We used a web-based randomisation system to assign participants to either standard lifestyle advice via newsletter (control arm) or a technology-mediated low-intensity behavioural WLM programme (intervention arm). The intervention comprised a single face-to-face goal-setting meeting, self-monitoring, and remote feedback on weight, diet, and physical activity via links embedded in short message service (SMS). All participants were provided with wirelessly connected weighing scales, but only participants in the intervention arm were instructed to weigh themselves daily and told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as frequency of self-weighing, objective physical activity (via accelerometry), psychological variables, and cost-effectiveness. The study was powered to detect a between-group weight difference of ±2.5 kg at follow-up. Overall, 264 participants (92%) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95% CI 0.5-3.1) in the intervention group (n = 131) and 1.8 kg (95% CI 0.6-3.0) in the control group (n = 133). There was no evidence of an effect on weight at 12 months (difference in adjusted mean weight change from baseline: -0.07 [95% CI 1.7 to -1.9], p = 0.9). Intervention participants weighed themselves more frequently than control participants and were more physically active. Intervention participants reported greater satisfaction with weight outcomes, more planning for dietary and physical activity goals and for managing lapses, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed. CONCLUSIONS: There was no difference in the WLM of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter. The intervention affected some, but not all, process-related secondary outcomes of the trial. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

AB - BACKGROUND: Scalable weight loss maintenance (WLM) interventions for adults with obesity are lacking but vital for the health and economic benefits of weight loss to be fully realised. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss (≥5%) compared to standard lifestyle advice. METHODS AND FINDINGS: The NULevel trial was an open-label randomised controlled superiority trial in 288 adults recruited April 2014 to May 2015 with weight loss of ≥5% within the previous 12 months, from a pre-weight loss BMI of ≥30 kg/m2. Participants were self-selected, and the majority self-certified previous weight loss. We used a web-based randomisation system to assign participants to either standard lifestyle advice via newsletter (control arm) or a technology-mediated low-intensity behavioural WLM programme (intervention arm). The intervention comprised a single face-to-face goal-setting meeting, self-monitoring, and remote feedback on weight, diet, and physical activity via links embedded in short message service (SMS). All participants were provided with wirelessly connected weighing scales, but only participants in the intervention arm were instructed to weigh themselves daily and told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as frequency of self-weighing, objective physical activity (via accelerometry), psychological variables, and cost-effectiveness. The study was powered to detect a between-group weight difference of ±2.5 kg at follow-up. Overall, 264 participants (92%) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95% CI 0.5-3.1) in the intervention group (n = 131) and 1.8 kg (95% CI 0.6-3.0) in the control group (n = 133). There was no evidence of an effect on weight at 12 months (difference in adjusted mean weight change from baseline: -0.07 [95% CI 1.7 to -1.9], p = 0.9). Intervention participants weighed themselves more frequently than control participants and were more physically active. Intervention participants reported greater satisfaction with weight outcomes, more planning for dietary and physical activity goals and for managing lapses, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed. CONCLUSIONS: There was no difference in the WLM of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter. The intervention affected some, but not all, process-related secondary outcomes of the trial. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

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DO - 10.1371/journal.pmed.1002793

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