Best Start - Weight Management During Pregnancy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity in Pregnancy
• Intervention / Treatment: Behavioral: Foodwise in Pregnancy

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 Type: Interventional
• Enrollment (Actual): 526
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Llantrisant, United Kingdom, CF72 8XR
    • Royal Glamorgan Hospital
  • Merthyr Tydfil, United Kingdom, CF47 9DT
    • Prince Charles Hospital
  • Mountain Ash, United Kingdom, CF45 4BZ
    • Ysbyty Cwm Cynon Hospital
  • Tonypandy, United Kingdom, CF40 2LX
    • Ysbyty Cwm Rhondda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants in the Intervention Group; 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.	Behavioral: Foodwise in Pregnancy; 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.
No Intervention: Participants in the Control Group; Control Group - will continue with routine antenatal care, unchanged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index - Weight and height recordings will be used to calculate BMI in kg/m^2 at 12 weeks.	Body Mass Index.	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.	36 weeks gestation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of babies born Pre-term - babies born <37 weeks.	Babies born to participants of the study at <37 weeks gestation.	<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.	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.	Participant booking appointment to 4 weeks postpartum.
Mode of delivery - Caesarean section.	Participants delivering by Caesarean section will be recorded.	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.	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.	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.	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.	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.	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.	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.	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.	At birth.
Number of high birth weight babies born - Macrosomia.	Weight of baby at birth higher than 3.99kg	At birth.
Number of Stillbirths.	Stillbirth - Baby born dead after 24 weeks gestation.	24 weeks gestation to date of delivery.
Number of Neonatal deaths.	Neonatal death - Death of a baby within the first 28 days of life.	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.	From birth to 14 days postpartum.
Number of babies born needing Neonatal intensive care unit (NICU) admission.	Babies born needing intensive care intervention.	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).	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.	Up to 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking status of study participant. Self reported measure and confirmed using piCObaby Smokerlyzer CO parts per million (PPM).	Self reported and CO validated measurement of study participant smoking status at initial booking interview and self-reported at 36 weeks.	Through study completion, an average of 1 year.
Folic acid compliance of study participant. Self reported measure. Pre-conception folic acid and early pregnancy folic acid at initial booking assessment. Recorded by Midwife.	Self reported assessment confirmed and recorded by Midwife.	Through study completion, an average of 1 year.
Socio-economic status of study participant derived from Welsh Index of Multiple Deprivation (WIMD) using Postcode.	Socio-economic status assessed from WIMD category.	Through study completion, an average of 1 year.
Alcohol consumption status of study participant at initial booking assessment and end of pregnancy. Self reported units consumed per week.	Alcohol consumption status. At booking and end of pregnancy. Recorded by Midwife.	Through study completion, an average of 1 year.
Substance misuse status at booking interview. Self reported recorded by Midwife.	Substance misuse status.	Through study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: Cwm Taf University Health Board (NHS)
• Collaborators: Cardiff University; Swansea University; Cardiff Metropolitan University; Burdett Trust for Nursing; Public Health Wales NHS Trust
• Investigators: Principal Investigator: Angela Jones, Public Health Wales NHS Trust; Study Director: Angela Jones, Public Health Wales NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): September 7, 2018
• Study Completion (Anticipated): May 1, 2027

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Obesity; Obesity, Maternal
• Other Study ID Numbers: CwmTUHB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

It is anticipated that the initial study findings will be available for dissemination by approximately January 2021.

The final Statistical Analysis Plan (SAP) is still to be determined.

• IPD Sharing Access Criteria: Access criteria is still to be determined.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No