Healthy Habits in Pregnancy and Beyond

NCT04336878 | Completed

• 2 other identifiers: QUB:B19/35 CHI/5434/2018266602
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Pregnancy Related

Keywords

Gestational weight gain; Habit formation; Diet; Physical Activity; Behaviour change intervention

Outcome Measures

Primary Outcomes (1)

• Acceptability of the intervention

  Interviews with participants and study-specific satisfaction rating scale (5 point scale from very satisfied to very dissatisfied)

  6 weeks postpartum

Secondary Outcomes (3)

• Feasibility of recruitment

  During 4 month study recruitment period

• Retention rate

  End of study - 6 weeks postpartum

• Acceptability to healthcare staff

  Conducted during the 4 month study recruitment and 5 month intervention delivery periods

Study Arms (2)

Healthy Habits in Pregnancy and Beyond intervention

EXPERIMENTAL

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.

Behavioral: Healthy Habits in Pregnancy and Beyond

Control group

NO INTERVENTION

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

Interventions

Healthy Habits in Pregnancy and Beyond BEHAVIORAL

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

Also known as: Ten Top Tips for a Healthy Weight

Healthy Habits in Pregnancy and Beyond intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• University of Leeds: collaborator
• University College, London: collaborator
• Belfast Health and Social Care Trust: collaborator
• Western Health and Social Care Trust: collaborator
• Sligo General Hospital: collaborator
• Our Lady of Lourdes Hospital, Drogheda: collaborator

Study Sites (1)

Centre for Public Health, Queen's University Belfast

Belfast, BT12 6BA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39550532 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Gestational Weight Gain; Motor Activity

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Body Weight Changes; Behavior

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Michelle McKinley, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the trial, it will not be possible to blind participants or intervention facilitators to group allocation. Researchers involved in collecting outcome data will not have access to details of group allocation and we will attempt to retain this blinding throughout. Participants will be asked not to discuss their group allocation with the researchers. Fidelity of blinding will be assessed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: April 7, 2020
• Study Start: March 1, 2021
• Primary Completion: September 25, 2022
• Study Completion: September 25, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)