Best Start - Weight Management During Pregnancy

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.

Conditions

• Obesity in Pregnancy

Interventions

BEHAVIORAL

Foodwise in Pregnancy

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.

Sponsors & Collaborators

• Burdett Trust for Nursing

  collaborator OTHER

• Public Health Wales NHS Trust

  collaborator UNKNOWN

• Swansea University

  collaborator OTHER

• Cardiff Metropolitan University

  collaborator OTHER

• Cardiff University

  collaborator OTHER

• Cwm Taf University Health Board (NHS)

  lead OTHER_GOV

Principal Investigators

• Angela Jones · Public Health Wales NHS Trust

• Angela Jones · Public Health Wales NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2018-09-07

Completion

2027-05-01

Countries

• United Kingdom

Study Locations