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

TY - JOUR

T1 - A randomised controlled trial of a personalised lifestyle coaching application in modifying periconceptional behaviours in women suffering from reproductive failures (iPLAN trial)

AU - Ng, Ka Ying Bonnie

AU - Wellstead, Susan

AU - Cheong, Ying

AU - Macklon, Nick

PY - 2018/12/4

Y1 - 2018/12/4

N2 - 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 ).

AB - 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 ).

KW - Adult

KW - Behavior Therapy/methods

KW - Counseling/methods

KW - Female

KW - Humans

KW - Infertility/psychology

KW - Infertility, Female/psychology

KW - Life Style

KW - Mentoring/methods

KW - Precision Medicine

KW - Prospective Studies

KW - Surveys and Questionnaires

U2 - 10.1186/s12905-018-0689-7

DO - 10.1186/s12905-018-0689-7

M3 - Journal article

C2 - 30514285

SN - 1472-6874

VL - 18

JO - BMC Women's Health

JF - BMC Women's Health

M1 - 196

ER -