iPLAN
Research type
Research Study
Full title
Impact of a Personalised Lifestyle coaching phone ApplicatioN in modifying peri-conceptional behaviours: a randomised controlled trial
IRAS ID
189437
Contact name
Ying Cheong
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
The impact of lifestyle, and in particular obesity and smoking on fertility has been well described, and advice regarding optimizing preconceptional lifestyle behaviours is imperative in managing couples presenting with reproductive failures. Moreover, funded access to IVF treatment is in many areas dependent on meeting criteria relating to smoking and BMI. While there is a widespread recognition of the impact of preconceptional health on fertility outcomes, there is paucity of data demonstrating the efficacy of interventions designed to ameliorate these factors in the preconceptional period.
Recently, a novel smartphone accessed lifestyle coaching application system has been developed, which may offer an effective, low burden and low cost alternative to passive information provided by NHS resources. We wish to test the efficacy of this intervention in women attending outpatients department at Princess Anne Hospital, Southampton.
Women who have given consent to take part will be randomized to either the intervention or control arm. Those randomized to the intervention arm will receive lifestyle coaching delivered via their smartphone. The program is automatically generated based on 5 identified risk factors and pregnancy state. Coaching includes sending facts, advice and recipes by SMS or email. Women will be screened on a 6- weekly basis to tailor their coaching program to the identified risk factors and their pregnancy state. The results of their risk profile are shown on their personal home page.
Those randomised to the control arm will be given access to the preconceptional advice provided by NHS websites and publications through their smartphone. The results will be analysed to determine whether a smartphone lifestyle coaching application can improve lifestyle behaviours in the periconceptional period compared to standard advice, through a validated lifestyle questionnaire at baseline, 12 and 24 weeks.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0129
Date of REC Opinion
21 Mar 2016
REC opinion
Favourable Opinion