A randomised controlled trial of a personalised lifestyle coaching application in modifying periconceptional behaviours in women suffering from reproductive failures (iPLAN trial)
A randomised controlled trial of a personalised lifestyle coaching application in modifying periconceptional behaviours in women suffering from reproductive failures (iPLAN trial)
BACKGROUND: Lifestyle, in particular obesity and smoking has significant impacts on fertility and an important focus for the treatment of reproductive failures is the optimisation of periconceptional lifestyle behaviours. The preimplantation intrauterine environment within the uterus is also key for embryo development and early programming. Although the benefits a healthy periconceptional lifestyle are well described, there remains a paucity of data demonstrating the efficacy of interventions designed to optimise preconceptional lifestyle behaviours and choices.
METHODS: This study is a prospective randomised controlled trial which aims to address the question of whether an online personalised lifestyle coaching application is an effective means of delivering periconceptional advice in women suffering from reproductive failures. Women suffering from subfertility or recurrent miscarriages attending the outpatient clinic will be randomised into either the intervention arm (personalised online lifestyle coaching application) or the control arm (standard periconceptional advice including information from NHS websites). Both groups will be asked to complete a validated lifestyle questionnaire at baseline, and 6, 12, 18 and 24 weeks after randomisation. The primary outcome is the composite dietary and lifestyle risk score at 12 weeks. The secondary outcomes will include compliance with the program, proportion achieving spontaneous conception during the study period and the dietary and lifestyle risk score at 24 weeks.
DISCUSSION: With this study, we aim to clarify whether a personalised online based lifestyle coaching application is more effective at improving behaviours than standard advice offered by National Health Service (NHS) resources. A personalised lifestyle coaching application may represent an empowering and cost effective means of delivering periconceptional advice in women with subfertility or recurrent miscarriages.
TRIAL REGISTRATION: The iPLAN trial was retrospectively registered ( ISRCTN 89523555 ).
196
Ng, Ka
9883fa87-e225-46b5-8e71-f12d38393841
Wellstead, Susan
2264823e-ae68-4976-bbf2-92da4ba21e59
Cheong, Ying
4efbba2a-3036-4dce-82f1-8b4017952c83
Macklon, Nick
7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e
4 December 2018
Ng, Ka
9883fa87-e225-46b5-8e71-f12d38393841
Wellstead, Susan
2264823e-ae68-4976-bbf2-92da4ba21e59
Cheong, Ying
4efbba2a-3036-4dce-82f1-8b4017952c83
Macklon, Nick
7db1f4fc-a9f6-431f-a1f2-297bb8c9fb7e
Ng, Ka, Wellstead, Susan, Cheong, Ying and Macklon, Nick
(2018)
A randomised controlled trial of a personalised lifestyle coaching application in modifying periconceptional behaviours in women suffering from reproductive failures (iPLAN trial).
BMC Women’s Health, 18 (1), .
(doi:10.1186/s12905-018-0689-7).
Abstract
BACKGROUND: Lifestyle, in particular obesity and smoking has significant impacts on fertility and an important focus for the treatment of reproductive failures is the optimisation of periconceptional lifestyle behaviours. The preimplantation intrauterine environment within the uterus is also key for embryo development and early programming. Although the benefits a healthy periconceptional lifestyle are well described, there remains a paucity of data demonstrating the efficacy of interventions designed to optimise preconceptional lifestyle behaviours and choices.
METHODS: This study is a prospective randomised controlled trial which aims to address the question of whether an online personalised lifestyle coaching application is an effective means of delivering periconceptional advice in women suffering from reproductive failures. Women suffering from subfertility or recurrent miscarriages attending the outpatient clinic will be randomised into either the intervention arm (personalised online lifestyle coaching application) or the control arm (standard periconceptional advice including information from NHS websites). Both groups will be asked to complete a validated lifestyle questionnaire at baseline, and 6, 12, 18 and 24 weeks after randomisation. The primary outcome is the composite dietary and lifestyle risk score at 12 weeks. The secondary outcomes will include compliance with the program, proportion achieving spontaneous conception during the study period and the dietary and lifestyle risk score at 24 weeks.
DISCUSSION: With this study, we aim to clarify whether a personalised online based lifestyle coaching application is more effective at improving behaviours than standard advice offered by National Health Service (NHS) resources. A personalised lifestyle coaching application may represent an empowering and cost effective means of delivering periconceptional advice in women with subfertility or recurrent miscarriages.
TRIAL REGISTRATION: The iPLAN trial was retrospectively registered ( ISRCTN 89523555 ).
Text
iPLAN Protocol BMC 21.11.18
- Accepted Manuscript
Text
s12905-018-0689-7
- Version of Record
More information
Accepted/In Press date: 22 November 2018
e-pub ahead of print date: 4 December 2018
Published date: 4 December 2018
Identifiers
Local EPrints ID: 426479
URI: http://eprints.soton.ac.uk/id/eprint/426479
ISSN: 1472-6874
PURE UUID: c8fdeb2f-6da0-4db6-a240-69831bc26271
Catalogue record
Date deposited: 28 Nov 2018 17:30
Last modified: 16 Mar 2024 07:20
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Contributors
Author:
Ka Ng
Author:
Susan Wellstead
Author:
Nick Macklon
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