Condition category
Pregnancy and Childbirth
Date applied
12/02/2018
Date assigned
22/02/2018
Last edited
22/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The impact of lifestyle, and in particular obesity and smoking on fertility has been well described, and advice regarding optimizing lifestyle behaviours around the time of conception 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 a healthy lifestyle on fertility outcomes, there is lack of data demonstrating the efficacy of interventions designed to improve healthy lifestyle behaviours for women planning to conceive. 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. The aim of this study is test the efficacy of this intervention in women suffering from infertility or recurrent miscarriages, attending the outpatients department.

Who can participate?
Women aged 18 to 45 who are suffering from fertility problems or have had recurring miscarriages.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group 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. Participants are 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 in the second group are given access to the standard lifestyle advice provided by NHS websites and publications through their smartphone. Lifestyle behaviours of the women are assessed using lifestyle questionnaire sent to them to complete at baseline, 12 and 24 weeks. The results are analysed to determine whether a smartphone lifestyle coaching application is more effective in improving lifestyle behaviours in women planning a pregnancy compared to standard advice

What are the possible benefits and risks of participating?
Woman participating in the study may benefit from a free lifestyle coaching smartphone application to use if they are randomised to the intervention arm. Due to the nature of the study, there are no direct risks for those taking part in the study. Patients will be informed of a telephone number for the research team should they wish to report any adverse events from the study. Patients reporting an adverse event from the study will be invited for follow up in the outpatient clinic one week after the reporting of the incident.

Where is the study run from?
1. Princess Anne Hospital (UK)
2. Salisbury District Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2015 to August 2019

Who is funding the study?
NIHR Southampton Respiratory Biomedical Research Unit (UK)

Who is the main contact?
Dr Ka Ying Bonnie Ng (Public)
bonnie.ng@doctors.org.uk

Trial website

https://www.smarterpregnancy.co.uk/research/

Contact information

Type

Public

Primary contact

Dr Ka Ying Bonnie Ng

ORCID ID

http://orcid.org/0000-0002-2770-6148

Contact details

Rm F 86
F Level Princess Anne Hospital
Coxford Road
Southampton
SO16 5YA
United Kingdom
+44 2381 206 856
bonnie.ng@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34220

Study information

Scientific title

iLAN: Impact of a Personalised Lifestyle coaching phone ApplicatioN in modifying peri-conceptional behaviours: a randomised controlled trial

Acronym

iPLAN

Study hypothesis

The hypothesis being tested in this study is that a smartphone based online lifestyle coaching application will be a more effective means of improving periconceptional lifestyle behaviours compared to conventional measures of periconceptional counselling through standard information provided by NHS websites and patient information leaflets.

Ethics approval

Yorkshire and The Humber Research Ethics Committee (NRES), 23/05/2016, ref: 16/YH/0129

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; UKCRC code/ Disease: Reproductive Health and Childbirth/ Other obstetric conditions, not elsewhere classified

Intervention

This study is a two-centre randomised control trial of using an online smartphone application in providing lifestyle coaching and modifying lifestyle parameters in women suffering from infertility or recurrent miscarriages. Women from both intervention and control group will be asked to visit the ‘Smarter Pregnancy’ website (www.smarterpregnancy.org.uk) and will be asked to register and activate their account by a unique validation code. Women will be asked to complete a baseline lifestyle questionnaire which assesses parameters including smoking habits, alcohol consumption, diet, exercise and weight, and then will be randomised by the ‘Smarter Pregnancy’ computer programme to either intervention arm or control arm. Both intervention and control group login to ‘Smarter Pregnancy’ using their personalised credentials created at registration.

In the intervention arm, women will have access to a personalised smartphone lifestyle coaching program. Through baseline and follow up lifestyle questionnaires (at 6, 12, 18 and 24 weeks) sent out via email, tailored lifestyle advice is generated; emails with tips, facts and recipes are sent to the intervention arm participants to encourage them to change unhealthy habits and maintain healthy habits. Those randomised to the control arm will have access to standard periconceptional advice, including information from NHS websites.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Composite dietary and lifestyle risk score is measured using a validated online lifestyle questionnaire sent to participants via the smarter pregnancy platform at 12 weeks after randomisation.

Secondary outcome measures

1. Percentage of patients remaining compliant with system is measured using case report forms at 12, 18 and 24 weeks after randomisation
2. Proportion achieving spontaneous conception during study period. Participants can update their pregnancy status via the online Smarter Pregnancy platform
3. Composite dietary and lifestyle risk score is measured using a validated online lifestyle questionnaire sent to participants via the smarter pregnancy platform at 24 weeks

Overall trial start date

01/10/2015

Overall trial end date

31/08/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age > 18 years and less than 45 years
2. Women suffering from subfertility or recurrent miscarriages attending the outpatient department
3. Fluent in the use and understanding of English
4. In possession of a smartphone capable of running the application
5. Actively trying to conceive

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 440; UK Sample Size: 440

Participant exclusion criteria

1. On a specific diet for medical reasons (including those on gluten free diet, specific carbohydrate diet or a healthy kidney diet)
2. Insulin dependent diabetes
3. Women who are undergoing any other means of lifestyle coaching, i.e. personal trainer or group lifestyle coaching (e.g. Slimming World)
4. Women undergoing oocyte donation treatment

Recruitment start date

01/06/2016

Recruitment end date

31/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Princess Anne Hospital
Coxford Road
Southampton
SO16 5YA
United Kingdom

Trial participating centre

Salisbury District Hospital
Odstock Road
Salisbury
SP2 8BJ
United Kingdom

Sponsor information

Organisation

University Hospitals Southampton NHS Foundation Trust

Sponsor details

R&D Department
University Hospitals NHS Trust
SGH - Level E
Laboratory & Pathology Block
SCBR - MP 138
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Southampton Respiratory Biomedical Research Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in high impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/08/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes