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Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) in primary care using total diet replacement products: a protocol for a randomised controlled trial
  1. Susan A Jebb,
  2. Nerys M Astbury,
  3. Sarah Tearne,
  4. Alecia Nickless,
  5. Paul Aveyard
  1. Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford UK
  1. Correspondence to Dr Nerys M Astbury; nerys.astbury{at}phc.ox.ac.uk

Footnotes

  • Contributors SAJ and PA designed the study and secured the funding. NMA and ST helped to develop the protocol. NMA is the trial manger and AN is the trial statistician.

  • Funding This research is funded by research grants from Cambridge Weight Plan Ltdand NIHR Collaboration forLeadership in Applied Health Research and Care (CLAHRC) Oxford at Oxford HealthNHS Foundation to the University of Oxford. The sponsor of the trial isthe University of Oxford. The protocol was initiated and designed by the investigators who have nopersonal financial relationships with the Cambridge Weight Plan Ltd. Although Cambridge Weight Plan were consultedand commented on the protocol, the final decisions lay with the investigators.There are no restrictions on publication of results arising from this study andthe contract between the funder and the University ensures that the fundingbody will have no input into the decisions regarding publication.

  • Competing interests SAJ and PA have led publicly funded trials in which the weight management intervention was provided free of charge by other commercial companies. They receive no personal financial benefits from these trials. NMA, ST and AN have no competing interests. Cambridge Weight Plan, as the funder of this trial, is also the manufacturer of the nutritional products used in the trial and provided the products used in the trial free of charge to the participants.

  • Ethics approval NHS Research Ethics Committee (South Central Oxford B Committee).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement For access to the data set, a formal request should be sent to theDROPLET study group. The request will only be considered when the principalresults of the study have been published.

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Footnotes

  • Contributors SAJ and PA designed the study and secured the funding. NMA and ST helped to develop the protocol. NMA is the trial manger and AN is the trial statistician.

  • Funding This research is funded by research grants from Cambridge Weight Plan Ltdand NIHR Collaboration forLeadership in Applied Health Research and Care (CLAHRC) Oxford at Oxford HealthNHS Foundation to the University of Oxford. The sponsor of the trial isthe University of Oxford. The protocol was initiated and designed by the investigators who have nopersonal financial relationships with the Cambridge Weight Plan Ltd. Although Cambridge Weight Plan were consultedand commented on the protocol, the final decisions lay with the investigators.There are no restrictions on publication of results arising from this study andthe contract between the funder and the University ensures that the fundingbody will have no input into the decisions regarding publication.

  • Competing interests SAJ and PA have led publicly funded trials in which the weight management intervention was provided free of charge by other commercial companies. They receive no personal financial benefits from these trials. NMA, ST and AN have no competing interests. Cambridge Weight Plan, as the funder of this trial, is also the manufacturer of the nutritional products used in the trial and provided the products used in the trial free of charge to the participants.

  • Ethics approval NHS Research Ethics Committee (South Central Oxford B Committee).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement For access to the data set, a formal request should be sent to theDROPLET study group. The request will only be considered when the principalresults of the study have been published.

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