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 (Corresponding Author), 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 Steele, Luke Vale, Rute Vieira, Martin White, Peter Wright, Vera Araujo-Soares

Research output: Contribution to journalArticle

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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
Article numbere1002793
Number of pages18
JournalPLoS Medicine
Volume16
Issue number5
DOIs
Publication statusPublished - 7 May 2019

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Weight Loss
Randomized Controlled Trials
Obesity
Maintenance
Weights and Measures
Life Style
Cost-Benefit Analysis
Accelerometry
Text Messaging
Weight Reduction Programs
Technology
Insurance Benefits
Random Allocation
Energy Intake
Weight Gain
Registries
Economics
Psychology
Diet
Control Groups

Keywords

  • behaviour
  • randomized controlled trial
  • obesity
  • overweight
  • weight loss
  • weight loss maintenance

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. (Corresponding Author); 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.; Steele, Alison; Vale, Luke; Vieira, Rute; White, Martin; Wright, Peter; Araujo-Soares, Vera.

In: PLoS Medicine, Vol. 16, No. 5, e1002793, 07.05.2019.

Research output: Contribution to journalArticle

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, Steele, A, Vale, L, Vieira, R, White, M, Wright, P & Araujo-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, e1002793. https://doi.org/10.1371/journal.pmed.1002793
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. ; Steele, Alison ; Vale, Luke ; Vieira, Rute ; White, Martin ; Wright, Peter ; Araujo-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 = "BackgroundScalable 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 findingsThe 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.ConclusionsThere 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 registrationThis trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).",
keywords = "behaviour, randomized controlled trial, obesity, overweight, weight loss, weight loss maintenance",
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 Steele and Luke Vale and Rute Vieira and Martin White and Peter Wright and Vera Araujo-Soares",
note = "The study is funded by the UK National Prevention Research Initiative (NPRI) Phase 4 (grant MR/J000477/1). The NPRI includes the following Funding Partners (in alphabetical order): Alzheimer’s Research Trust, Alzheimer’s Society, Biotechnology and Biological Sciences Research Council, British Heart Foundation, Cancer Research UK, Chief Scientist Office, Scottish Government Health Directorate, Department of Health, Diabetes UK, Economic and Social Research Council, Health and Social Care Research and Development Division of the Public Health Agency (HSC & R&D Division), Medical Research Council, The Stroke Association, Wellcome Trust, Welsh Assembly Government and World Cancer Research Fund. FFS is funded by Fuse, the Centre for Translational Research in Public Health, a UKCRC Public Health Research Centre of Excellence based on funding from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, and the National Institute for Health Research, under the auspices of the UK Clinical Research Collaboration. AA is funded by the National Institute of Health Research as an NIHR Research Professor. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.",
year = "2019",
month = "5",
day = "7",
doi = "10.1371/journal.pmed.1002793",
language = "English",
volume = "16",
journal = "PLoS Medicine",
issn = "1549-1277",
publisher = "Nature Publishing Group",
number = "5",

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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 - Steele, Alison

AU - Vale, Luke

AU - Vieira, Rute

AU - White, Martin

AU - Wright, Peter

AU - Araujo-Soares, Vera

N1 - The study is funded by the UK National Prevention Research Initiative (NPRI) Phase 4 (grant MR/J000477/1). The NPRI includes the following Funding Partners (in alphabetical order): Alzheimer’s Research Trust, Alzheimer’s Society, Biotechnology and Biological Sciences Research Council, British Heart Foundation, Cancer Research UK, Chief Scientist Office, Scottish Government Health Directorate, Department of Health, Diabetes UK, Economic and Social Research Council, Health and Social Care Research and Development Division of the Public Health Agency (HSC & R&D Division), Medical Research Council, The Stroke Association, Wellcome Trust, Welsh Assembly Government and World Cancer Research Fund. FFS is funded by Fuse, the Centre for Translational Research in Public Health, a UKCRC Public Health Research Centre of Excellence based on funding from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, and the National Institute for Health Research, under the auspices of the UK Clinical Research Collaboration. AA is funded by the National Institute of Health Research as an NIHR Research Professor. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

PY - 2019/5/7

Y1 - 2019/5/7

N2 - BackgroundScalable 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 findingsThe 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.ConclusionsThere 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 registrationThis trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

AB - BackgroundScalable 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 findingsThe 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.ConclusionsThere 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 registrationThis trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

KW - behaviour

KW - randomized controlled trial

KW - obesity

KW - overweight

KW - weight loss

KW - weight loss maintenance

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DO - 10.1371/journal.pmed.1002793

M3 - Article

VL - 16

JO - PLoS Medicine

JF - PLoS Medicine

SN - 1549-1277

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M1 - e1002793

ER -