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Published in: BMC Women's Health 1/2018

Open Access 01-12-2018 | Study protocol

A randomised controlled trial of a personalised lifestyle coaching application in modifying periconceptional behaviours in women suffering from reproductive failures (iPLAN trial)

Authors: Ka Ying Bonnie Ng, Susan Wellstead, Ying Cheong, Nick Macklon

Published in: BMC Women's Health | Issue 1/2018

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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).
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Literature
1.
go back to reference Fauser BC, et al. Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-sponsored 3rd PCOS consensus workshop group. Fertil Steril. 2012;97(1):28–38 e25.CrossRefPubMed Fauser BC, et al. Consensus on women's health aspects of polycystic ovary syndrome (PCOS): the Amsterdam ESHRE/ASRM-sponsored 3rd PCOS consensus workshop group. Fertil Steril. 2012;97(1):28–38 e25.CrossRefPubMed
2.
go back to reference Kermack AJ, et al. Amino acid composition of human uterine fluid: association with age, lifestyle and gynaecological pathology. Hum Reprod. 2015;30(4):917–24.CrossRefPubMedPubMedCentral Kermack AJ, et al. Amino acid composition of human uterine fluid: association with age, lifestyle and gynaecological pathology. Hum Reprod. 2015;30(4):917–24.CrossRefPubMedPubMedCentral
3.
go back to reference Sinclair K, et al. The periconceptional period, reproduction and long-term health of offspring: the importance of one-carbon metabolism. Hum Reprod Update. 2013;19(6):640–55.CrossRefPubMed Sinclair K, et al. The periconceptional period, reproduction and long-term health of offspring: the importance of one-carbon metabolism. Hum Reprod Update. 2013;19(6):640–55.CrossRefPubMed
4.
go back to reference Homan GF, Davies M, Norman R. The impact of lifestyle factors on reproductive performance in the general population and those undergoing infertility treatment: a review. Hum Reprod Update. 2007;13(3):209–23.CrossRefPubMed Homan GF, Davies M, Norman R. The impact of lifestyle factors on reproductive performance in the general population and those undergoing infertility treatment: a review. Hum Reprod Update. 2007;13(3):209–23.CrossRefPubMed
5.
go back to reference Atrash HK, et al. Preconception care for improving perinatal outcomes: the time to act. Matern Child Health J. 2006;10(5 Suppl):S3–11.CrossRefPubMed Atrash HK, et al. Preconception care for improving perinatal outcomes: the time to act. Matern Child Health J. 2006;10(5 Suppl):S3–11.CrossRefPubMed
7.
go back to reference Inskip HM, et al. Cohort profile: the Southampton Women's survey. Int J Epidemiol. 2006;35(1):42–8.CrossRefPubMed Inskip HM, et al. Cohort profile: the Southampton Women's survey. Int J Epidemiol. 2006;35(1):42–8.CrossRefPubMed
8.
go back to reference Jaddoe VW, et al. The generation R study: design and cohort update 2012. Eur J Epidemiol. 2012;27(9):739–56.CrossRefPubMed Jaddoe VW, et al. The generation R study: design and cohort update 2012. Eur J Epidemiol. 2012;27(9):739–56.CrossRefPubMed
9.
go back to reference Suarez L, et al. Neural tube defects on the Texas-Mexico border: what we've learned in the 20 years since the Brownsville cluster. Birth Defects Res A Clin Mol Teratol. 2012;94(11):882–92.CrossRefPubMed Suarez L, et al. Neural tube defects on the Texas-Mexico border: what we've learned in the 20 years since the Brownsville cluster. Birth Defects Res A Clin Mol Teratol. 2012;94(11):882–92.CrossRefPubMed
10.
go back to reference Nohr EA, et al. Does low participation in cohort studies induce bias? Epidemiology. 2006;17(4):413–8.CrossRefPubMed Nohr EA, et al. Does low participation in cohort studies induce bias? Epidemiology. 2006;17(4):413–8.CrossRefPubMed
11.
go back to reference Crozier SR, et al. Dietary patterns in pregnant women: a comparison of food-frequency questionnaires and 4 d prospective diaries. Br J Nutr. 2008;99(4):869–75.CrossRefPubMed Crozier SR, et al. Dietary patterns in pregnant women: a comparison of food-frequency questionnaires and 4 d prospective diaries. Br J Nutr. 2008;99(4):869–75.CrossRefPubMed
12.
go back to reference Bloomfield FH, Spiroski AM, Harding JE. Fetal growth factors and fetal nutrition. Semin Fetal Neonatal Med. 2013;18(3):118–123.CrossRefPubMed Bloomfield FH, Spiroski AM, Harding JE. Fetal growth factors and fetal nutrition. Semin Fetal Neonatal Med. 2013;18(3):118–123.CrossRefPubMed
13.
go back to reference van Uitert EM, et al. Periconception maternal characteristics and embryonic growth trajectories: the Rotterdam predict study. Hum Reprod. 2013;28(12):3188–96.CrossRefPubMed van Uitert EM, et al. Periconception maternal characteristics and embryonic growth trajectories: the Rotterdam predict study. Hum Reprod. 2013;28(12):3188–96.CrossRefPubMed
14.
go back to reference Jaddoe VW, et al. First trimester fetal growth restriction and cardiovascular risk factors in school age children: population based cohort study. BMJ. 2014;348:g14.CrossRefPubMedPubMedCentral Jaddoe VW, et al. First trimester fetal growth restriction and cardiovascular risk factors in school age children: population based cohort study. BMJ. 2014;348:g14.CrossRefPubMedPubMedCentral
15.
go back to reference Vujkovic M, et al. The preconception Mediterranean dietary pattern in couples undergoing in vitro fertilization/intracytoplasmic sperm injection treatment increases the chance of pregnancy. Fertil Steril. 2010;94(6):2096–101.CrossRefPubMed Vujkovic M, et al. The preconception Mediterranean dietary pattern in couples undergoing in vitro fertilization/intracytoplasmic sperm injection treatment increases the chance of pregnancy. Fertil Steril. 2010;94(6):2096–101.CrossRefPubMed
16.
go back to reference Hammiche F, et al. Tailored preconceptional dietary and lifestyle counselling in a tertiary outpatient clinic in the Netherlands. Hum Reprod. 2011;26(9):2432–41.CrossRefPubMed Hammiche F, et al. Tailored preconceptional dietary and lifestyle counselling in a tertiary outpatient clinic in the Netherlands. Hum Reprod. 2011;26(9):2432–41.CrossRefPubMed
Metadata
Title
A randomised controlled trial of a personalised lifestyle coaching application in modifying periconceptional behaviours in women suffering from reproductive failures (iPLAN trial)
Authors
Ka Ying Bonnie Ng
Susan Wellstead
Ying Cheong
Nick Macklon
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Women's Health / Issue 1/2018
Electronic ISSN: 1472-6874
DOI
https://doi.org/10.1186/s12905-018-0689-7

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