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.

Rumana Newlands (Corresponding Author), Maria Ntessalen, Julia Clark, Shona Fielding, Pat Hoddinott, Steven Darryll Heys, Geraldine McNeill, Leone Christina Agnese Craig

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Abstract

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 three groups: Weight Watchers® referral (for 12 sessions of meetings & digital tools) plus five 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 61.0y; body mass index 30.2kg/m2) 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 -3.67kg (-5.67, -2.07) in WW Plus; -6.03kg (7.61, -4.44) in WW group and +0.19kg (-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 Key words: Breast cancer, weight loss, Weight Watchers, group support, pilot trial, feasibility
Original languageEnglish
Article number24
Number of pages17
JournalPilot & Feasibility Studies
Volume5
DOIs
Publication statusPublished - 13 Feb 2019

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Nutritionists
Weight Loss
Referral and Consultation
Randomized Controlled Trials
Breast Neoplasms
Weights and Measures
Dietetics
Quality of Life
Weight Reduction Programs
Control Groups
Group Processes
Insurance Benefits
Random Allocation
Workload
Body Mass Index
Maintenance
Costs and Cost Analysis
Recurrence
Survival
Mortality

Keywords

  • Breast cancer
  • weight loss
  • Weight Watchers
  • group support
  • pilot trial
  • feasibility

Cite this

@article{08b5ccb65c4e40a88084125b8325812e,
title = "Pilot randomised controlled trial of Weight Watchers{\circledR} referral with or without dietitian-led group support for weight loss in women treated for breast cancer: the BRIGHT (BReast cancer weIGHT loss) trial.",
abstract = "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{\circledR} 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 three groups: Weight Watchers{\circledR} referral (for 12 sessions of meetings & digital tools) plus five breast cancer-tailored dietitian led group support sessions (WW Plus: n=14); Weight Watchers{\circledR} referral only (WW: n=16) or Control (Weight Watchers{\circledR} 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 61.0y; body mass index 30.2kg/m2) 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 -3.67kg (-5.67, -2.07) in WW Plus; -6.03kg (7.61, -4.44) in WW group and +0.19kg (-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 Key words: Breast cancer, weight loss, Weight Watchers, group support, pilot trial, feasibility",
keywords = "Breast cancer, weight loss, Weight Watchers, group support, pilot trial, feasibility",
author = "Rumana Newlands and Maria Ntessalen and Julia Clark and Shona Fielding and Pat Hoddinott and Heys, {Steven Darryll} and Geraldine McNeill and Craig, {Leone Christina Agnese}",
note = "RN was supported by a PhD studentship from the Fraserburgh Ladies Moonlight Prowl and Cancer Research Aberdeen and North East Scotland (CRANES). LCAC and GMcN acknowledge support from the RESAS programme of the Scottish Government.",
year = "2019",
month = "2",
day = "13",
doi = "10.1186/s40814-019-0405-x",
language = "English",
volume = "5",
journal = "Pilot & Feasibility Studies",
issn = "2055-5784",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Pilot randomised controlled trial of Weight Watchers® referral with or without dietitian-led group support for weight loss in women treated for breast cancer

T2 - the BRIGHT (BReast cancer weIGHT loss) trial.

AU - Newlands, Rumana

AU - Ntessalen, Maria

AU - Clark, Julia

AU - Fielding, Shona

AU - Hoddinott, Pat

AU - Heys, Steven Darryll

AU - McNeill, Geraldine

AU - Craig, Leone Christina Agnese

N1 - RN was supported by a PhD studentship from the Fraserburgh Ladies Moonlight Prowl and Cancer Research Aberdeen and North East Scotland (CRANES). LCAC and GMcN acknowledge support from the RESAS programme of the Scottish Government.

PY - 2019/2/13

Y1 - 2019/2/13

N2 - 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 three groups: Weight Watchers® referral (for 12 sessions of meetings & digital tools) plus five 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 61.0y; body mass index 30.2kg/m2) 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 -3.67kg (-5.67, -2.07) in WW Plus; -6.03kg (7.61, -4.44) in WW group and +0.19kg (-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 Key words: Breast cancer, weight loss, Weight Watchers, group support, pilot trial, feasibility

AB - 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 three groups: Weight Watchers® referral (for 12 sessions of meetings & digital tools) plus five 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 61.0y; body mass index 30.2kg/m2) 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 -3.67kg (-5.67, -2.07) in WW Plus; -6.03kg (7.61, -4.44) in WW group and +0.19kg (-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 Key words: Breast cancer, weight loss, Weight Watchers, group support, pilot trial, feasibility

KW - Breast cancer

KW - weight loss

KW - Weight Watchers

KW - group support

KW - pilot trial

KW - feasibility

UR - https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0405-x

UR - http://www.mendeley.com/research/pilot-randomised-controlled-trial-weight-watchers-referral-without-dietitianled-group-support-weight

U2 - 10.1186/s40814-019-0405-x

DO - 10.1186/s40814-019-0405-x

M3 - Article

VL - 5

JO - Pilot & Feasibility Studies

JF - Pilot & Feasibility Studies

SN - 2055-5784

M1 - 24

ER -