NCT04336878: HHIPBe

Healthy Habits in Pregnancy and Beyond

Completed NA Last updated 20 February 2024

What this trial tests

NA trial testing Healthy Habits in Pregnancy and Beyond in Overweight and Obesity in 25 participants. Completed in 25 September 2022.

Timeline

1 March 2021

Primary endpoint
25 September 2022

25 September 2022

Quick facts

Lead sponsor	Queen's University, Belfast
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	25
Start date	1 March 2021
Primary completion	25 September 2022
Estimated completion	25 September 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• Healthy Habits in Pregnancy and Beyond

Conditions studied

• Overweight and Obesity — all drugs for Overweight and Obesity →
• Pregnancy Related — all drugs for Pregnancy Related →

Sponsor

Queen's University, Belfast

Who can join

18 and older, female only, with Overweight and Obesity or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of a habit-based intervention to support healthy eating and physical activity behaviours for pregnant women with overweight or obesity: Healthy Habits in Pregnancy and Beyond (HHIPBe).
   McClelland J, Gallagher D, Moore SE, McGirr C, et al · · 2024 · cited 1× · PMID 39550532 · DOI 10.1186/s12884-024-06945-7
2. Development of a habit-based intervention to support healthy eating and physical activity behaviours for pregnant women with overweight or obesity: Healthy Habits in Pregnancy and Beyond (HHIPBe)
   McClelland J, Gallagher D, Moore SE, McGirr C, et al · · 2024 · DOI 10.21203/rs.3.rs-3759776/v1