Assessing the effectiveness of a personalised lifestyle coaching phone application in changing behaviours of women planning a pregnancy

Not Applicable

Completed

• Conditions: 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; Pregnancy and Childbirth; Peri-conceptional health

• Registration Number: ISRCTN89523555
• Lead Sponsor: niversity Hospitals Southampton NHS Foundation Trust

Brief Summary

1. 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30514285

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-22
• Study Completion: 2019-08-31
• Last Update Posted: 1 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 440

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Percentage of patients remaining compliant with system is measured using case report forms at 12, 18 and 24 weeks after randomisation<br> 2. Proportion achieving spontaneous conception during study period. Participants can update their pregnancy status via the online Smarter Pregnancy platform<br> 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<br>