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Completed

NCT Number: NCT04336878

Healthy Habits in Pregnancy and Beyond

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Body Weight Changes Gestational Weight Gain Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Related Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Public Health, Queen's University Belfast

Belfast, BT12 6BA, United Kingdom

About this study

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:

  • Assess the numbers of eligible pregnant women accessing the healthcare services at each partner healthcare site;
  • Assess screening, recruitment and attrition rates;
  • Assess willingness of healthcare staff to recruit women and deliver the HHIPBe intervention as part of routine antenatal clinical care;
  • Assess indicators of engagement with the intervention by women (self-reported logbooks/ app data/ qualitative post-intervention interviews);
  • Assess the acceptability of randomisation to a 'usual care' group and women's views on completion of study measures at each time-point;
  • Assess the acceptability of the intervention to women;
  • Assess fidelity of intervention implementation across each partner site i.e. was HHIPBe delivered as intended;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ten Top Tips for a Healthy Weight

Primary outcomes

  1. Acceptability of the intervention

    Time frame: 6 weeks postpartum

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

Secondary outcomes

  1. Feasibility of recruitment

    Time frame: During 4 month study recruitment period

    Number of women recruited to the study

  2. Retention rate

    Time frame: End of study - 6 weeks postpartum

    Number of women completing the study

  3. Acceptability to healthcare staff

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

    Interviews with staff recruiting and delivering the intervention

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Belfast Health and Social Care Trust
  • Our Lady of Lourdes Hospital, Drogheda
  • Sligo General Hospital
  • University College, London
  • University of Leeds
  • Western Health and Social Care Trust

Registry information

Official study title

Exploring the Feasibility and Acceptability of Integrating a Habit-based Intervention for Pregnant Women With Overweight or Obesity Into Existing Antenatal Care Pathways on the Island of Ireland: The HHIPBe Feasibility Study

Acronym: HHIPBe

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2020
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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