Overweight and ObesityHHIPBeNCT04336878
Healthy Habits in Pregnancy and Beyond
A study testing Healthy Habits in Pregnancy and Beyond in people with Overweight and Obesity and Pregnancy Related, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Pregnancy Related
- What is being tested?
- Healthy Habits in Pregnancy and Beyond
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 25 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Public Health, Queen's University Belfast
Belfast, BT12 6BA
About this study
Official 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
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.
Read the 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:
- 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.
- Conditions
- Overweight and Obesity, Pregnancy Related
- Being tested
- Healthy Habits in Pregnancy and Beyond
- Keywords
- Gestational weight gain, Habit formation, Diet, Physical Activity, Behaviour change intervention
- Medical subject headings
- Overweight, Obesity, Gestational Weight Gain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Habits in Pregnancy and BeyondBehavioural
Also called Ten Top Tips for a Healthy Weight
Habit-based intervention to support the development of 10 healthy dietary and activity behaviours for pregnant women with overweight or obesity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention
Interviews with participants and study-specific satisfaction rating scale (5 point scale from very satisfied to very dissatisfied)
Measured: 6 weeks postpartum
Secondary outcomes (3)
Feasibility of recruitment
Number of women recruited to the study
Measured: During 4 month study recruitment period
Retention rate
Number of women completing the study
Measured: End of study - 6 weeks postpartum
Acceptability to healthcare staff
Interviews with staff recruiting and delivering the intervention
Measured: Conducted during the 4 month study recruitment and 5 month intervention delivery periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Mar 2021
- Primary completion25 Sep 2022
- Study completion25 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, University College, London, Belfast Health and Social Care Trust, Western Health and Social Care Trust, Sligo General Hospital, Our Lady of Lourdes Hospital, Drogheda
- Responsible party
- Principal investigator, Michelle McKinley, Queen's University, Belfast
- Investigators
- Michelle McKinley, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336878
- Sponsor's protocol ID
- QUB:B19/35 CHI/5434/2018
- Other IDs
- 266602
- Acronym
- HHIPBe
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39550532
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04336878
- Acronym / sponsor ID
- HHIPBe / QUB:B19/35 CHI/5434/2018
- Conditions
- Overweight and Obesity, Pregnancy Related
- Keywords
- Gestational weight gain, Habit formation, Diet, Physical Activity, Behaviour change intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- University of Leeds, University College, London, Belfast Health and Social Care Trust, Western Health and Social Care Trust, Sligo General Hospital, Our Lady of Lourdes Hospital, Drogheda
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 25 Sep 2022 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Habits in Pregnancy and Beyond intervention | Experimental | Behavioral: Healthy Habits in Pregnancy and BeyondIntervention 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. |
| Control group | No intervention | –The control group will receive 'usual' antenatal care which does not involve routinely delivered specific or standardised dietary advice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Habits in Pregnancy and BeyondAlso: Ten Top Tips for a Healthy WeightHabit-based intervention to support the development of 10 healthy dietary and activity behaviours for pregnant women with overweight or obesity. | Behavioural | Healthy Habits in Pregnancy and Beyond intervention |
Primary outcome
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)
3 secondary outcomes
Feasibility of recruitment
Time frame: During 4 month study recruitment period
Retention rate
Time frame: End of study - 6 weeks postpartum
Acceptability to healthcare staff
Time frame: Conducted during the 4 month study recruitment and 5 month intervention delivery periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 39550532McClelland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle McKinley, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Habits in Pregnancy and Beyond in people with Overweight and Obesity and Pregnancy Related, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.