Best Start - Weight Management During Pregnancy
1 other identifier
interventional
526
1 country
4
Brief Summary
The investigators know that being overweight during pregnancy increases the health risks to both mum and baby. There is good evidence that diet or exercise, or both, during pregnancy can reduce excessive weight gain. The Best Start study aims to test the theory that obese pregnant women with a Body Mass Index (BMI) of 30 or over who participate in a structured programme of nutrition and lifestyle advice (Foodwise in Pregnancy ™) will achieve the recommended weight gain during pregnancy of no less than 5kg and no more than 9.1kg. The investigators would like to find out if pregnant women with a BMI of 30 or over who receive the Best Start intervention are more likely to effectively manage weight gain during pregnancy. To achieve this, the investigators will undertake a trial that randomly puts participants into an experimental group, or a control group, which will compare those who receive the intervention to those who continue with routine antenatal care. The investigators are aiming to recruit around 500 women during the study period. 250 will receive the Best Start intervention, and 250 will continue with routine antenatal care. The investigators would also like to find out if women who gain the recommended weight during pregnancy have better outcomes, compared to women who gain more or less weight. To do this the investigators will look at the routine information collected during antenatal and postnatal care, for both mum and baby. To do this regardless of the group clients are randomised to, the investigators will ask for permission to look at the routine information within the participants maternity record. This information includes, weight gained during pregnancy, whether the baby is born early, the type of labour and delivery, and any complications during the pregnancy or delivery that may have resulted in the need for additional care for mum or baby. The results of the study will be prepared for publication in scientific journals, and for presentation at scientific conferences. All participants will be able to obtain a copy of the results once they have been published and any information that could identify participants will be removed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2018
CompletedFirst Submitted
Initial submission to the registry
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
ExpectedAugust 22, 2024
August 1, 2024
1.2 years
January 28, 2019
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Body Mass Index - Weight and height recordings will be used to calculate BMI in kg/m^2 at 12 weeks.
Body Mass Index.
12 weeks gestation.
Weight of participant recorded in kg at 36 weeks.
The odds ratio of pregnant women with a BMI of ≥30 who do not gain excessive weight and achieve the optimum recommended weight gain during pregnancy of 5-9.1kg in the intervention group compared with the control group.
36 weeks gestation.
Secondary Outcomes (19)
Number of babies born Pre-term - babies born <37 weeks.
<37 weeks gestation
Number of participants identified with Pre-eclampsia - New hypertension presenting after 20 weeks of pregnancy with significant proteinuria.
20 weeks +.
Number of participants identified with Thromboembolism - venous thromboembolism (VTE) - deep vein thrombosis(DVT) or pulmonary embolism (PE).
Participant booking appointment to 4 weeks postpartum.
Mode of delivery - Caesarean section.
Date of delivery.
Post surgical site infection - a type of healthcare associated infection in which a wound infection occurs after an invasive (surgical) procedure.
Date of delivery to 4 weeks postpartum.
- +14 more secondary outcomes
Other Outcomes (5)
Smoking status of study participant. Self reported measure and confirmed using piCObaby Smokerlyzer CO parts per million (PPM).
Through study completion, an average of 1 year.
Folic acid compliance of study participant. Self reported measure. Pre-conception folic acid and early pregnancy folic acid at initial booking assessment. Recorded by Midwife.
Through study completion, an average of 1 year.
Socio-economic status of study participant derived from Welsh Index of Multiple Deprivation (WIMD) using Postcode.
Through study completion, an average of 1 year.
- +2 more other outcomes
Study Arms (2)
Participants in the Intervention Group
EXPERIMENTALIntervention Group - will undertake a programme of 7 x 2 hour group sessions, following the scripted 'Foodwise in Pregnancy' manual of nutrition information; practical cooking sessions; and information on low impact exercise.
Participants in the Control Group
NO INTERVENTIONControl Group - will continue with routine antenatal care, unchanged.
Interventions
A 7 week programme of nutrition and lifestyle advice, delivered in community venues by trained Healthy Lifestyle Support Workers (HLSWs). Participants must meet study inclusion criteria.
Eligibility Criteria
You may qualify if:
- Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of 30 or over and reside in Cwm Taf University Health Board area.
- Aged over 16.
- Capable of giving informed consent.
- Singleton and multiple pregnancies.
You may not qualify if:
- Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of less than 29.9 and reside in Cwm Taf University Health Board area.
- Aged under 16.
- Incapable of giving informed consent.
- Any women who have pre-existing diabetes, or develop gestational diabetes during their pregnancy.
- Any health condition that means the health professional looking after the patient feels would contra-indicate involvement in this programme (e.g. losing the ability to consent during the programme)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cwm Taf University Health Board (NHS)lead
- Burdett Trust for Nursingcollaborator
- Public Health Wales NHS Trustcollaborator
- Swansea Universitycollaborator
- Cardiff Metropolitan Universitycollaborator
- Cardiff Universitycollaborator
Study Sites (4)
Royal Glamorgan Hospital
Llantrisant, CF72 8XR, United Kingdom
Prince Charles Hospital
Merthyr Tydfil, CF47 9DT, United Kingdom
Ysbyty Cwm Cynon Hospital
Mountain Ash, CF45 4BZ, United Kingdom
Ysbyty Cwm Rhondda Hospital
Tonypandy, CF40 2LX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Jones
Public Health Wales NHS Trust
- STUDY DIRECTOR
Angela Jones
Public Health Wales NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2019
First Posted
March 14, 2019
Study Start
July 1, 2017
Primary Completion
September 7, 2018
Study Completion (Estimated)
May 1, 2027
Last Updated
August 22, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- It is anticipated that the initial study findings will be available for dissemination by approximately January 2021. The final Statistical Analysis Plan (SAP) is still to be determined.
- Access Criteria
- Access criteria is still to be determined.
Study findings will be disseminated via The Burdett Trust for Nursing, Cwm Taf University Health Board, Public Health Wales NHS Trust, health boards and interested clinicians and submission of a paper to a scientific journal for peer-review e.g. the British Journal of Midwifery. The results of our study will be prepared for publication in scientific journals, and for presentation at scientific conferences. All participants will be able to obtain a copy of the results once they have been published, no patient identifiable information will be included.