Healthy Habits in Pregnancy and Beyond

Summary

More than 50% of pregnant women are considered to have a BMI that is classified as overweight or obese when they present for antenatal care. Overweight and obesity in pregnancy is associated with complications and poorer health outcomes for mothers and their babies, as well as risk for excessive gestational weight gain and postpartum weight retention, increasing the likelihood of long-term obesity for these women. There is also evidence that excess maternal weight and weight gain in pregnancy is associated with obesity in the offspring from early childhood through to adolescence. There is an urgent need for simple, effective interventions targeting lifestyle which can be delivered during routine healthcare.

The overall aim of this study is to pilot test the delivery of a brief, habit-based weight management intervention, 'Healthy Habits In Pregnancy and Beyond', for pregnant women with overweight and obesity (body mass index between 25.0 \& \<38.0 kg/m2) in early pregnancy, to gather preliminary information on the intervention and to establish the feasibility and acceptability of delivering this intervention into routine antenatal care and existing antenatal care pathways across four geographical locations in Northern Ireland and the Republic of Ireland.

This study is a two-arm randomised controlled feasibility study. Healthcare staff in four partner sites will be trained in introducing the study to the target sample and in delivering the intervention. 80 women will be recruited and randomised to control (n=40) or intervention group (n=40) (20 at each site). Women randomised to the intervention group will receive a brief intervention to encourage the development of ten healthy habits in relation to diet, physical activity and weight management, plus their local routine antenatal care. The intervention will be delivered by a designated midwife at each site or a member of the research team, and is aimed to be integrated into appointments already attended by women as part of routine antenatal care. Women randomised to the control group will receive their local routine antenatal care.

Conditions

• Overweight and Obesity
• Pregnancy Related

Interventions

BEHAVIORAL

Healthy Habits in Pregnancy and Beyond

Habit-based intervention to support the development of 10 healthy dietary and activity behaviours for pregnant women with overweight or obesity.

Sponsors & Collaborators

• University of Leeds

  collaborator OTHER

• University College, London

  collaborator OTHER

• Belfast Health and Social Care Trust

  collaborator OTHER

• Western Health and Social Care Trust

  collaborator OTHER

• Sligo General Hospital

  collaborator OTHER

• Our Lady of Lourdes Hospital, Drogheda

  collaborator OTHER_GOV

• Queen's University, Belfast

  lead OTHER

Principal Investigators

• Michelle McKinley, PhD · Queen's University, Belfast

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-03-01

Primary Completion

2022-09-25

Completion

2022-09-25

Countries

• United Kingdom

Study Locations