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
Study website
Contact information
Type
Public
Contact name
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/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
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(s)
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
Study setting(s)
Internet/virtual
Study 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
Primary outcome measure
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 study start date
01/10/2015
Overall study end date
31/08/2019
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
England, United Kingdom
Study participating centre
Princess Anne Hospital
Coxford Road
Southampton
SO16 5YA
United Kingdom
Study 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
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
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.
Intention to publish date
31/05/2021
Individual participant data (IPD) Intention to share
No
IPD sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V3 | 17/03/2016 | 22/02/2018 | No | Yes |
| Protocol article | protocol | 04/12/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN89523555_PIS_V3_17Mar16.pdf Uploaded 22/02/2018