Obesity in PregnancyNCT03875300
Best Start - Weight Management During Pregnancy
A study testing Foodwise in Pregnancy in people with Obesity in Pregnancy, run by Cwm Taf University Health Board (NHS) at 4 sites in United Kingdom.
Trial summary
The investigators know that being overweight during pregnancy increases the health risks to both mum and baby. There is good evidence that diet or exercise, or both, during pregnancy can reduce excessive weight gain. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity in Pregnancy
- What is being tested?
- Foodwise in Pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Jul 2017to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of 30 or over and reside in Cwm Taf University Health Board area.
- Aged over 16.
- Capable of giving informed consent.
- Singleton and multiple pregnancies.
Who cannot join
- Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of less than 29.9 and reside in Cwm Taf University Health Board area.
- Aged under 16.
- Incapable of giving informed consent.
- Any women who have pre-existing diabetes, or develop gestational diabetes during their pregnancy.
- Any health condition that means the health professional looking after the patient feels would contra-indicate involvement in this programme (e.g. losing the ability to consent during the programme)
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Royal Glamorgan Hospital
Llantrisant, CF72 8XR
Prince Charles Hospital
Merthyr Tydfil, CF47 9DT
Ysbyty Cwm Cynon Hospital
Mountain Ash, CF45 4BZ
Ysbyty Cwm Rhondda Hospital
Tonypandy, CF40 2LX
About this study
The investigators know that being overweight during pregnancy increases the health risks to both mum and baby. There is good evidence that diet or exercise, or both, during pregnancy can reduce excessive weight gain. The Best Start study aims to test the theory that obese pregnant women with a Body Mass Index (BMI) of 30 or over who participate in a structured programme of nutrition and lifestyle advice (Foodwise in Pregnancy ™) will achieve the recommended weight gain during pregnancy of no less than 5kg and no more than 9.1kg.
The investigators would like to find out if pregnant women with a BMI of 30 or over who receive the Best Start intervention are more likely to effectively manage weight gain during pregnancy. To achieve this, the investigators will undertake a trial that randomly puts participants into an experimental group, or a control group, which will compare those who receive the intervention to those who continue with routine antenatal care. The investigators are aiming to recruit around 500 women during the study period. 250 will receive the Best Start intervention, and 250 will continue with routine antenatal care.
Read more
The investigators would also like to find out if women who gain the recommended weight during pregnancy have better outcomes, compared to women who gain more or less weight. To do this the investigators will look at the routine information collected during antenatal and postnatal care, for both mum and baby. To do this regardless of the group clients are randomised to, the investigators will ask for permission to look at the routine information within the participants maternity record. This information includes, weight gained during pregnancy, whether the baby is born early, the type of labour and delivery, and any complications during the pregnancy or delivery that may have resulted in the need for additional care for mum or baby.
The results of the study will be prepared for publication in scientific journals, and for presentation at scientific conferences. All participants will be able to obtain a copy of the results once they have been published and any information that could identify participants will be removed.
Read the detailed description
The intervention will invite obese pregnant women with a BMI ≥30 to participate in a research study where participants may be offered a programme of nutrition and lifestyle advice, unless participants meet the exclusion criteria.
The programme of nutrition and lifestyle advice will comprise a series of weekly 7 x 2 hour group sessions, which will be delivered in community venues by trained Healthy Lifestyle Support Workers (HLSWs) employed within the maternity service.
The group sessions will follow the scripted "Foodwise in PregnancyTM" manual of nutrition information; practical cooking sessions; and information on low impact exercise e.g. walking. 'Foodwise in PregnancyTM' has been developed by a group of NHS Dietitians and Midwives and is adapted from the existing Foodwise for Life programme. Pedometers will be provided at session three to raise participants awareness of the benefits of physical activity. The programme is participative in its approach to experiential learning.
The group sessions will also promote breastfeeding (All Wales Maternity Strategy Key Performance Indicator/Measure) to assist healthy weight gain for babies, healthy weaning and the importance of play and physical activity. Delivery of the sessions will be quality assured by a specialist public health dietitian and public health midwife employed within Cwm Taf University Health Board.
Because eligible women will initially be referred by a midwife, all midwives will be trained by a public health dietitian on the "Eating for 1, Healthy and Active for 2" Royal College of Midwives accredited compact training, to ensure a sensitive and effective conversation (using motivational interviewing techniques) that raises the issue of excess weight in pregnancy. The Healthy Lifestyle Support Workers, delivering the intervention, will also attend this training.
- Conditions
- Obesity in Pregnancy
- Being tested
- Foodwise in Pregnancy
- Medical subject headings
- Pregnancy in Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foodwise in PregnancyBehavioural
A 7 week programme of nutrition and lifestyle advice, delivered in community venues by trained Healthy Lifestyle Support Workers (HLSWs). Participants must meet study inclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Participants in the Intervention Group | Experimental | Intervention Group - will undertake a programme of 7 x 2 hour group sessions, following the scripted 'Foodwise in Pregnancy' manual of nutrition information; practical cooking sessions; and information on low impact exercise. Receives: Behavioral: Foodwise in Pregnancy |
| Participants in the Control Group | No intervention | Control Group - will continue with routine antenatal care, unchanged. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index - Weight and height recordings will be used to calculate BMI in kg/m^2 at 12 weeks.
Body Mass Index.
Measured: 12 weeks gestation.
Weight of participant recorded in kg at 36 weeks.
The odds ratio of pregnant women with a BMI of ≥30 who do not gain excessive weight and achieve the optimum recommended weight gain during pregnancy of 5-9.1kg in the intervention group compared with the control group.
Measured: 36 weeks gestation.
Secondary outcomes (19)
Number of babies born Pre-term - babies born <37 weeks.
Babies born to participants of the study at <37 weeks gestation.
Measured: <37 weeks gestation
Number of participants identified with Pre-eclampsia - New hypertension presenting after 20 weeks of pregnancy with significant proteinuria.
Participants will be monitored for signs of pre-eclampsia - hypertension and proteinuria.
Measured: 20 weeks +.
Number of participants identified with Thromboembolism - venous thromboembolism (VTE) - deep vein thrombosis(DVT) or pulmonary embolism (PE).
All participants will be monitored for VTE, DVT and PE in early pregnancy and again during the intrapartum and postpartum periods.
Measured: Participant booking appointment to 4 weeks postpartum.
Mode of delivery - Caesarean section.
Participants delivering by Caesarean section will be recorded.
Measured: Date of delivery.
Post surgical site infection - a type of healthcare associated infection in which a wound infection occurs after an invasive (surgical) procedure.
Signs of post post-surgical infections will be monitored and treated.
Measured: Date of delivery to 4 weeks postpartum.
Number of participants identified with Postpartum haemorrhage (PPH); Primary and Secondary.
Participants will be monitored for signs of PPH.
PPH can be broken down into stages:
Stage 1: 500-999ml blood loss; Stage 2: 1000-1499ml blood loss; Stage 3:>1500ml blood loss (major obstetric haemorrhage); Primary postpartum haemorrhage (PPH) the loss of > 500ml of blood after vaginal delivery or < 1000ml of blood after caesarean section delivery within 24 hours of delivery. Secondary PPH is defined as abnormal bleeding from the birth canal between 24 hours and 12 weeks postnatally.
Measured: 24 hours post-delivery to 12 weeks postpartum.
Number of participants referred to the study.
Number of obese pregnant women referred into the programme by their midwife.
Measured: July 2017-September 2018.
Number of participants Breastfeeding at birth, and exclusively breastfeeding at 10 days and 6 months.
The number of study participants who breastfeed at birth, and exclusively breastfeed at 10 days and 6 months.
Measured: Postnatal; Birth; 10 days and 6 months.
Percentage of weight management programme sessions attended by participants.
Uptake and acceptability of the programme to obese pregnant women measured through the percentage of weight management programme sessions attended.
Measured: Programme completion, an average of 7 weeks.
Number of post programme interviews/focus groups with eligible participants, following a scripted questionnaire.
Uptake and acceptability of the programme to obese pregnant women measured through the number of post study interviews/focus groups with eligible participants.
Measured: Programme completion, an average of 7 weeks.
Self reported changes in study participants measured through a self completed questionnaire at the end of the weight management programme.
Self reported changes in nutrition knowledge, skills, physical activity levels, confidence and behaviour.
Measured: Programme completion, an average of 7 weeks.
Number of low birth weight babies born, weighing < 2.5kg.
Weight of baby at birth lower than 2.5kg.
Measured: At birth.
Number of high birth weight babies born - Macrosomia.
Weight of baby at birth higher than 3.99kg
Measured: At birth.
Number of Stillbirths.
Stillbirth - Baby born dead after 24 weeks gestation.
Measured: 24 weeks gestation to date of delivery.
Number of Neonatal deaths.
Neonatal death - Death of a baby within the first 28 days of life.
Measured: Date of birth to 28 days.
Number of babies born needing Transitional Care.
Babies born needing enhanced care but not Special Care Baby Unit (SCBU)admission.
Measured: From birth to 14 days postpartum.
Number of babies born needing Neonatal intensive care unit (NICU) admission.
Babies born needing intensive care intervention.
Measured: From birth to 14 days postpartum.
Rate of obesity in children born to study participants at age 4-5 years. Weight and height will be combined to calculate BMI in kg/m^2.
Rate of obesity measured at age 4-5 years, recorded as part of the Child Measurement Programme for Wales (All Wales Surveillance System).
Measured: Age 4-5 years.
Acceptability of the programme to relevant staff groups - measured through semi-structured audio recorded interview (face-to-face or via telephone).
The acceptability of the programme to relevant staff groups will be assessed though 1:1 or focus group sessions. A sample of healthcare professionals to include midwife, dietician, healthy lifestyle support worker, obstetrician, sonographer, anaesthetist. Open and closed ended questioning.
Measured: Up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Jul 2017
- Primary completion7 Sep 2018
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity in PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial
- Masking
- None (open label)
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cwm Taf University Health Board (NHS)
- Sponsor type
- Other government
- Collaborators
- Burdett Trust for Nursing, Public Health Wales, Swansea University, Cardiff Metropolitan University, Cardiff University
- Responsible party
- Sponsor
- Investigators
- Angela Jones, Principal investigator, Public Health WalesAngela Jones, Study director, Public Health Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875300
- Sponsor's protocol ID
- CwmTUHB
- Status last verified
- Aug 2024
- First submitted
- 28 Jan 2019
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study findings will be disseminated via The Burdett Trust for Nursing, Cwm Taf University Health Board, Public Health Wales NHS Trust, health boards and interested clinicians and submission of a paper to a scientific journal for peer-review e.g. the British Journal of Midwifery. The results of our study will be prepared for publication in scientific journals, and for presentation at scientific conferences. All participants will be able to obtain a copy of the results once they have been published, no patient identifiable information will be included.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Start - Weight Management During Pregnancy
- ClinicalTrials.gov ID
- NCT03875300
- Acronym / sponsor ID
- CwmTUHB
- Conditions
- Obesity in Pregnancy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 526 participants (actual)
- Lead sponsor
- Cwm Taf University Health Board (NHS)Other government
- Collaborators
- Burdett Trust for Nursing, Public Health Wales, Swansea University, Cardiff Metropolitan University, Cardiff University
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 7 Sep 2018 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 14 Mar 2019 (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.
The investigators know that being overweight during pregnancy increases the health risks to both mum and baby. There is good evidence that diet or exercise, or both, during pregnancy can reduce excessive weight gain. The Best Start study aims to test the theory that obese pregnant women with a Body Mass Index (BMI) of 30 or over who participate in a structured programme of nutrition and lifestyle advice (Foodwise in Pregnancy ™) will achieve the recommended weight gain during pregnancy of no less than 5kg and no more than 9.1kg.
The investigators would like to find out if pregnant women with a BMI of 30 or over who receive the Best Start intervention are more likely to effectively manage weight gain during pregnancy. To achieve this, the investigators will undertake a trial that randomly puts participants into an experimental group, or a control group, which will compare those who receive the intervention to those who continue with routine antenatal care. The investigators are aiming to recruit around 500 women during the study period. 250 will receive the Best Start intervention, and 250 will continue with routine antenatal care.
The investigators would also like to find out if women who gain the recommended weight during pregnancy have better outcomes, compared to women who gain more or less weight. To do this the investigators will look at the routine information collected during antenatal and postnatal care, for both mum and baby. To do this regardless of the group clients are randomised to, the investigators will ask for permission to look at the routine information within the participants maternity record. This information includes, weight gained during pregnancy, whether the baby is born early, the type of labour and delivery, and any complications during the pregnancy or delivery that may have resulted in the need for additional care for mum or baby.
The results of the study will be prepared for publication in scientific journals, and for presentation at scientific conferences. All participants will be able to obtain a copy of the results once they have been published and any information that could identify participants will be removed.
Detailed description
The intervention will invite obese pregnant women with a BMI ≥30 to participate in a research study where participants may be offered a programme of nutrition and lifestyle advice, unless participants meet the exclusion criteria.
The programme of nutrition and lifestyle advice will comprise a series of weekly 7 x 2 hour group sessions, which will be delivered in community venues by trained Healthy Lifestyle Support Workers (HLSWs) employed within the maternity service.
The group sessions will follow the scripted "Foodwise in PregnancyTM" manual of nutrition information; practical cooking sessions; and information on low impact exercise e.g. walking. 'Foodwise in PregnancyTM' has been developed by a group of NHS Dietitians and Midwives and is adapted from the existing Foodwise for Life programme. Pedometers will be provided at session three to raise participants awareness of the benefits of physical activity. The programme is participative in its approach to experiential learning.
The group sessions will also promote breastfeeding (All Wales Maternity Strategy Key Performance Indicator/Measure) to assist healthy weight gain for babies, healthy weaning and the importance of play and physical activity. Delivery of the sessions will be quality assured by a specialist public health dietitian and public health midwife employed within Cwm Taf University Health Board.
Because eligible women will initially be referred by a midwife, all midwives will be trained by a public health dietitian on the "Eating for 1, Healthy and Active for 2" Royal College of Midwives accredited compact training, to ensure a sensitive and effective conversation (using motivational interviewing techniques) that raises the issue of excess weight in pregnancy. The Healthy Lifestyle Support Workers, delivering the intervention, will also attend this training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| Participants in the Intervention Group | Experimental | Behavioral: Foodwise in PregnancyIntervention Group - will undertake a programme of 7 x 2 hour group sessions, following the scripted 'Foodwise in Pregnancy' manual of nutrition information; practical cooking sessions; and information on low impact exercise. |
| Participants in the Control Group | No intervention | –Control Group - will continue with routine antenatal care, unchanged. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of 30 or over and reside in Cwm Taf University Health Board area.
- Aged over 16.
- Capable of giving informed consent.
- Singleton and multiple pregnancies.
Key exclusion criteria (5 listed)
- Pregnant women who at their early pregnancy dating scan (optimum time 12 weeks gestation, but with a tolerance of up to 16 full weeks gestation for women who book late) have a BMI of less than 29.9 and reside in Cwm Taf University Health Board area.
- Aged under 16.
- Incapable of giving informed consent.
- Any women who have pre-existing diabetes, or develop gestational diabetes during their pregnancy.
- Any health condition that means the health professional looking after the patient feels would contra-indicate involvement in this programme (e.g. losing the ability to consent during the programme)
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 |
|---|---|---|
| Foodwise in PregnancyA 7 week programme of nutrition and lifestyle advice, delivered in community venues by trained Healthy Lifestyle Support Workers (HLSWs). Participants must meet study inclusion criteria. | Behavioural | Participants in the Intervention Group |
Primary outcome
Body Mass Index - Weight and height recordings will be used to calculate BMI in kg/m^2 at 12 weeks.
Time frame: 12 weeks gestation.
Body Mass Index.
Weight of participant recorded in kg at 36 weeks.
Time frame: 36 weeks gestation.
The odds ratio of pregnant women with a BMI of ≥30 who do not gain excessive weight and achieve the optimum recommended weight gain during pregnancy of 5-9.1kg in the intervention group compared with the control group.
19 secondary outcomes
Number of babies born Pre-term - babies born <37 weeks.
Time frame: <37 weeks gestation
Number of participants identified with Pre-eclampsia - New hypertension presenting after 20 weeks of pregnancy with significant proteinuria.
Time frame: 20 weeks +.
Number of participants identified with Thromboembolism - venous thromboembolism (VTE) - deep vein thrombosis(DVT) or pulmonary embolism (PE).
Time frame: Participant booking appointment to 4 weeks postpartum.
Mode of delivery - Caesarean section.
Time frame: Date of delivery.
Post surgical site infection - a type of healthcare associated infection in which a wound infection occurs after an invasive (surgical) procedure.
Time frame: Date of delivery to 4 weeks postpartum.
Number of participants identified with Postpartum haemorrhage (PPH); Primary and Secondary.
Time frame: 24 hours post-delivery to 12 weeks postpartum.
Number of participants referred to the study.
Time frame: July 2017-September 2018.
Number of participants Breastfeeding at birth, and exclusively breastfeeding at 10 days and 6 months.
Time frame: Postnatal; Birth; 10 days and 6 months.
Percentage of weight management programme sessions attended by participants.
Time frame: Programme completion, an average of 7 weeks.
Number of post programme interviews/focus groups with eligible participants, following a scripted questionnaire.
Time frame: Programme completion, an average of 7 weeks.
Self reported changes in study participants measured through a self completed questionnaire at the end of the weight management programme.
Time frame: Programme completion, an average of 7 weeks.
Number of low birth weight babies born, weighing < 2.5kg.
Time frame: At birth.
Number of high birth weight babies born - Macrosomia.
Time frame: At birth.
Number of Stillbirths.
Time frame: 24 weeks gestation to date of delivery.
Number of Neonatal deaths.
Time frame: Date of birth to 28 days.
Number of babies born needing Transitional Care.
Time frame: From birth to 14 days postpartum.
Number of babies born needing Neonatal intensive care unit (NICU) admission.
Time frame: From birth to 14 days postpartum.
Rate of obesity in children born to study participants at age 4-5 years. Weight and height will be combined to calculate BMI in kg/m^2.
Time frame: Age 4-5 years.
Acceptability of the programme to relevant staff groups - measured through semi-structured audio recorded interview (face-to-face or via telephone).
Time frame: Up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: Yes. Study findings will be disseminated via The Burdett Trust for Nursing, Cwm Taf University Health Board, Public Health Wales NHS Trust, health boards and interested clinicians and submission of a paper to a scientific journal for peer-review e.g. the British Journal of Midwifery. The results of our study will be prepared for publication in scientific journals, and for presentation at scientific conferences. All participants will be able to obtain a copy of the results once they have been published, no patient identifiable information will be included.
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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.
Angela Jones principal investigator
Public Health Wales
Angela Jones study director
Public Health Wales
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foodwise in Pregnancy in people with Obesity in Pregnancy, run by Cwm Taf University Health Board (NHS) at 4 sites 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Body Mass Index - Weight and height recordings will be used to calculate BMI in kg/m^2 at 12 weeks. (time frame: 12 weeks gestation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2024.