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Start At The Beginning: a nutrition and lifestyle digital intervention for women planning a pregnancy

Efficacy of a nutrition and lifestyle digital intervention for women planning a pregnancy: a pilot randomised controlled trial in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN03259732
Enrollment
300
Registered
2014-07-31
Start date
2014-09-01
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Reproductive health and childbirth

Interventions

Participants will be randomized into either the intervention or the control group. All participants will have access to the online education tool (app) to input their dietary and lifestyle behaviours.

Sponsors

University College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged between 18 and 45 who are planning a pregnancy within the following 12 months 2. Willingness to be randomised to either the control or intervention group 3. Ability to access the internet, via a desktop PC, laptop, smartphone, tablet, or any other device whereby the participant can access SmarterPregnancy 4. Enough understanding of English to be able to follow the online application and the leaflet 5. Willingness to participate in the trial, which includes following the protocol for 6 months

Exclusion criteria

Exclusion criteria: Specific dietary requirements that may conflicts with the online application advice, i.e. strict vegetarians and vegans

Design outcomes

Primary

MeasureTime frame
A composite risk score is calculated at 6 months post randomisation from self-reported data on smoking, consumption of fruit, vegetables and supplementation with folic acid in both groups

Secondary

MeasureTime frame
1. Recruitment rate: the proportion of women planning a pregnancy at recruitment visits; the proportion eligible for the trial; proportion entering (randomised into) the trial 2. The number and rate (per participant) of queries and requests for help in using the web-based intervention 3. Follow-up rates by group at 3 and 6 months after randomisation 4. Participant experience of using both interventions will be assessed through qualitative interviews 5. Pregnancy: all women who become pregnant during the pilot trial will be asked to complete a short 6-item validated questionnaire, the London Measure of Unplanned Pregnancy (LMUP.com)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026