Healthy Habits in Pregnancy and Beyond

NCT ID: NCT04336878

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-09-25

Brief 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.

Detailed Description

The primary objective of the feasibility study is to provide a decision on whether to proceed to a full-scale, multicentre RCT.

The two-arm randomised controlled feasibility study will:

1. Assess the numbers of eligible pregnant women accessing the healthcare services at each partner healthcare site;

2. Assess screening, recruitment and attrition rates;

3. Assess willingness of healthcare staff to recruit women and deliver the HHIPBe intervention as part of routine antenatal clinical care;

4. Assess indicators of engagement with the intervention by women (self-reported logbooks/ app data/ qualitative post-intervention interviews);

5. Assess the acceptability of randomisation to a 'usual care' group and women's views on completion of study measures at each time-point;

6. Assess the acceptability of the intervention to women;

7. Assess fidelity of intervention implementation across each partner site i.e. was HHIPBe delivered as intended;

8. Trial the outcome measures that would be used in a full trial of HHIPBe (and gather data to inform a power calculation for a full trial) including assessment of: GWG, habit-formation and diet and activity behaviours up to 6 weeks postpartum; and health economics measures, alongside an exploration of the potential for data linkage to maternal and neonatal outcomes in each jurisdiction.

Conditions

Overweight and Obesity; Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Healthy Habits in Pregnancy and Beyond intervention

Intervention delivered in early pregnancy during an existing antenatal appointment. 1:1 intervention session (15-20 minutes) with the intervention facilitator (clinician/researcher). Participants provided with a self-guided leaflet for weight management focusing on making 10 simple diet and activity behaviours habitual, including advice on food choice \& purchasing, portion size, eating behaviour \& keeping active. The tips promote habit formation, nutrition awareness, avoidance of behavioural relapse, and reiterate guidance for pregnant women. Participants provided with a record-keeping logbook and access to an 'app' to self-monitor their weight and behaviours against the 10 target behaviours, during pregnancy and up to 6 weeks postpartum.

Group Type: EXPERIMENTAL

Healthy Habits in Pregnancy and Beyond

Intervention Type: BEHAVIORAL

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

Control group

The control group will receive 'usual' antenatal care which does not involve routinely delivered specific or standardised dietary advice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Ten Top Tips for a Healthy Weight

Eligibility Criteria

Inclusion Criteria

• Pregnant Women.
• Body Mass Index between ≥25.0 kg/m2 and <38.0 kg/m2.
• Primiparous or Multiparous.
• Women capable of providing informed consent and of providing consent on behalf of their child.

Exclusion Criteria

• Twin or multiple pregnancies.
• Insufficient English to understand intervention and written materials.
• Nutritional complications i.e. previous or current eating disorder, following a special diet, in receipt of specialist dietary advice.
• Pregnancy not viable as determined by the patient's clinical team.
• Have been referred to another weight management service by their clinical team during pregnancy that is not part of routine antenatal care.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leeds

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

Belfast Health and Social Care Trust

OTHER

Sponsor Role: collaborator

Western Health and Social Care Trust

OTHER

Sponsor Role: collaborator

Sligo General Hospital

OTHER

Sponsor Role: collaborator

Our Lady of Lourdes Hospital, Drogheda

OTHER_GOV

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Michelle McKinley

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle McKinley, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Centre for Public Health, Queen's University Belfast

Belfast, , United Kingdom

Countries

United Kingdom

References

McClelland J, Gallagher D, Moore SE, McGirr C, Beeken RJ, Croker H, Eastwood KA, O'Neill RF, Woodside JV, McGowan L, McKinley MC. 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). BMC Pregnancy Childbirth. 2024 Nov 16;24(1):760. doi: 10.1186/s12884-024-06945-7.

Reference Type: DERIVED

PMID: 39550532 (View on PubMed)

Other Identifiers

266602

Identifier Type: OTHER

Identifier Source: secondary_id

QUB:B19/35 CHI/5434/2018

Identifier Type: -

Identifier Source: org_study_id