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Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial

BACKGROUND: Being overweight or obese following breast cancer diagnosis can increase cancer recurrence and mortality, so effective interventions for weight loss in this group could enhance survival. A pilot randomised controlled trial was conducted to assess whether a weight loss programme comprisin...

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Autores principales: Newlands, Rumana S. N., Ntessalen, Maria, Clark, Julia, Fielding, Shona, Hoddinott, Pat, Heys, Steven D., McNeill, Geraldine, Craig, Leone C. A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373055/
https://www.ncbi.nlm.nih.gov/pubmed/30805199
http://dx.doi.org/10.1186/s40814-019-0405-x
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author Newlands, Rumana S. N.
Ntessalen, Maria
Clark, Julia
Fielding, Shona
Hoddinott, Pat
Heys, Steven D.
McNeill, Geraldine
Craig, Leone C. A.
author_facet Newlands, Rumana S. N.
Ntessalen, Maria
Clark, Julia
Fielding, Shona
Hoddinott, Pat
Heys, Steven D.
McNeill, Geraldine
Craig, Leone C. A.
author_sort Newlands, Rumana S. N.
collection PubMed
description BACKGROUND: Being overweight or obese following breast cancer diagnosis can increase cancer recurrence and mortality, so effective interventions for weight loss in this group could enhance survival. A pilot randomised controlled trial was conducted to assess whether a weight loss programme comprising generic Weight Watchers® referral offered to women treated for breast cancer with or without additional breast cancer-tailored dietetic support is feasible and shows promise for improving weight and quality of life (QoL). METHODS: Participants were randomly allocated to 3 groups: Weight Watchers® referral (for 12 sessions of meetings and digital tools) plus 5 breast cancer-tailored dietitian-led group support sessions (WW Plus: n = 14), Weight Watchers® referral only (WW: n = 16) or control (Weight Watchers® referral after 3 months, n = 15). Feasibility was assessed based on retention rate, recruitment and randomisation process, meeting attendance, suitability of the setting and outcome measurement tools, unintended consequences, cost and observations of the dietetic sessions. Outcomes were measured at 0, 3 (‘trial exit’) and 12 months post intervention. RESULTS: The response rate to the invitation was 43% (140/327) of whom 58 were eligible and 45 (median age 61.0 years; body mass index 30.2 kg/m(2)) were randomised. Data from 38 (84%) and 30 (67%) participants were available at trial exit and 12 months respectively. Feasibility issues included slow recruitment process, lack of blinding throughout, weighing scales not measuring > 150 kg, lack of clear instructions for completing QoL questionnaire and workload and time pressures in delivering dietetic sessions. Participants had good attendance rate at group meetings and no serious unintended consequences were reported. WW Plus was most expensive to run. Mean (95% CI) weight change at trial exit was − 3.67 kg (− 5.67, − 2.07) in WW Plus, − 6.03 kg (− 7.61, − 4.44) in WW group and + 0.19 kg (− 1.45, + 1.83) in control group. About 40% of the WW Plus, 64% of the WW group and 56% of the control group lost ≥ 5% of their baseline weight by 12 months. All groups showed promise for improving QoL at trial exit but only the WW group maintained significant improvements from baseline at 12 months. CONCLUSIONS: The trial procedures were feasible, with some modifications. This pilot trial indicates the benefits of providing free WW vouchers for weight loss maintenance and improving QoL but provided no evidence that including additional dietetic support would add any extra value. Further research with WW with long-term follow-up should be undertaken to assess weight loss sustainability and benefit on health outcomes in this patient group. TRIAL REGISTRATION: ISRCTN-29623418. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-019-0405-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-63730552019-02-25 Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial Newlands, Rumana S. N. Ntessalen, Maria Clark, Julia Fielding, Shona Hoddinott, Pat Heys, Steven D. McNeill, Geraldine Craig, Leone C. A. Pilot Feasibility Stud Research BACKGROUND: Being overweight or obese following breast cancer diagnosis can increase cancer recurrence and mortality, so effective interventions for weight loss in this group could enhance survival. A pilot randomised controlled trial was conducted to assess whether a weight loss programme comprising generic Weight Watchers® referral offered to women treated for breast cancer with or without additional breast cancer-tailored dietetic support is feasible and shows promise for improving weight and quality of life (QoL). METHODS: Participants were randomly allocated to 3 groups: Weight Watchers® referral (for 12 sessions of meetings and digital tools) plus 5 breast cancer-tailored dietitian-led group support sessions (WW Plus: n = 14), Weight Watchers® referral only (WW: n = 16) or control (Weight Watchers® referral after 3 months, n = 15). Feasibility was assessed based on retention rate, recruitment and randomisation process, meeting attendance, suitability of the setting and outcome measurement tools, unintended consequences, cost and observations of the dietetic sessions. Outcomes were measured at 0, 3 (‘trial exit’) and 12 months post intervention. RESULTS: The response rate to the invitation was 43% (140/327) of whom 58 were eligible and 45 (median age 61.0 years; body mass index 30.2 kg/m(2)) were randomised. Data from 38 (84%) and 30 (67%) participants were available at trial exit and 12 months respectively. Feasibility issues included slow recruitment process, lack of blinding throughout, weighing scales not measuring > 150 kg, lack of clear instructions for completing QoL questionnaire and workload and time pressures in delivering dietetic sessions. Participants had good attendance rate at group meetings and no serious unintended consequences were reported. WW Plus was most expensive to run. Mean (95% CI) weight change at trial exit was − 3.67 kg (− 5.67, − 2.07) in WW Plus, − 6.03 kg (− 7.61, − 4.44) in WW group and + 0.19 kg (− 1.45, + 1.83) in control group. About 40% of the WW Plus, 64% of the WW group and 56% of the control group lost ≥ 5% of their baseline weight by 12 months. All groups showed promise for improving QoL at trial exit but only the WW group maintained significant improvements from baseline at 12 months. CONCLUSIONS: The trial procedures were feasible, with some modifications. This pilot trial indicates the benefits of providing free WW vouchers for weight loss maintenance and improving QoL but provided no evidence that including additional dietetic support would add any extra value. Further research with WW with long-term follow-up should be undertaken to assess weight loss sustainability and benefit on health outcomes in this patient group. TRIAL REGISTRATION: ISRCTN-29623418. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-019-0405-x) contains supplementary material, which is available to authorized users. BioMed Central 2019-02-13 /pmc/articles/PMC6373055/ /pubmed/30805199 http://dx.doi.org/10.1186/s40814-019-0405-x Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Newlands, Rumana S. N.
Ntessalen, Maria
Clark, Julia
Fielding, Shona
Hoddinott, Pat
Heys, Steven D.
McNeill, Geraldine
Craig, Leone C. A.
Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial
title Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial
title_full Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial
title_fullStr Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial
title_full_unstemmed Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial
title_short Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial
title_sort pilot randomised controlled trial of weight watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the bright (breast cancer weight loss) trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373055/
https://www.ncbi.nlm.nih.gov/pubmed/30805199
http://dx.doi.org/10.1186/s40814-019-0405-x
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