Clinical trial NCT03875300: Best Start - Weight Management During Pregnancy
Official title: Best Start - Weight Management During Pregnancy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity in Pregnancy
Lead sponsor: Cwm Taf University Health Board (NHS)
Sponsor class: OTHER_GOV
Collaborators: name: Burdett Trust for Nursing
name: Public Health Wales NHS Trust
name: Swansea University
name: Cardiff Metropolitan University
name: Cardiff University
First posted: 2019-03-14
Enrollment: 526
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Control Trial
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Body Mass Index - Weight and height recordings will be used to calculate BMI in kg/m^2 at 12 weeks.
timeFrame: 12 weeks gestation.
measure: Weight of participant recorded in kg at 36 weeks.
timeFrame: 36 weeks gestation.
Secondary outcomes:
measure: Number of babies born Pre-term - babies born <37 weeks.
timeFrame: <37 weeks gestation
measure: Number of participants identified with Pre-eclampsia - New hypertension presenting after 20 weeks of pregnancy with significant proteinuria.
timeFrame: 20 weeks +.
measure: Number of participants identified with Thromboembolism - venous thromboembolism (VTE) - deep vein thrombosis(DVT) or pulmonary embolism (PE).
timeFrame: Participant booking appointment to 4 weeks postpartum.
measure: Mode of delivery - Caesarean section.
timeFrame: Date of delivery.
measure: Post surgical site infection - a type of healthcare associated infection in which a wound infection occurs after an invasive (surgical) procedure.
timeFrame: Date of delivery to 4 weeks postpartum.
measure: Number of participants identified with Postpartum haemorrhage (PPH); Primary and Secondary.
timeFrame: 24 hours post-delivery to 12 weeks postpartum.
measure: Number of participants referred to the study.
timeFrame: July 2017-September 2018.
measure: Number of participants Breastfeeding at birth, and exclusively breastfeeding at 10 days and 6 months.
timeFrame: Postnatal; Birth; 10 days and 6 months.
measure: Percentage of weight management programme sessions attended by participants.
timeFrame: Programme completion, an average of 7 weeks.
measure: Number of post programme interviews/focus groups with eligible participants, following a scripted questionnaire.
timeFrame: Programme completion, an average of 7 weeks.
measure: Self reported changes in study participants measured through a self completed questionnaire at the end of the weight management programme.
timeFrame: Programme completion, an average of 7 weeks.
measure: Number of low birth weight babies born, weighing < 2.5kg.
timeFrame: At birth.
measure: Number of high birth weight babies born - Macrosomia.
timeFrame: At birth.
measure: Number of Stillbirths.
timeFrame: 24 weeks gestation to date of delivery.
measure: Number of Neonatal deaths.
timeFrame: Date of birth to 28 days.
measure: Number of babies born needing Transitional Care.
timeFrame: From birth to 14 days postpartum.
measure: Number of babies born needing Neonatal intensive care unit (NICU) admission.
timeFrame: From birth to 14 days postpartum.
measure: 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.
timeFrame: Age 4-5 years.
measure: Acceptability of the programme to relevant staff groups - measured through semi-structured audio recorded interview (face-to-face or via telephone).
timeFrame: Up to 12 months.
Other outcomes:
measure: Smoking status of study participant. Self reported measure and confirmed using piCObaby Smokerlyzer CO parts per million (PPM).
timeFrame: Through study completion, an average of 1 year.
measure: 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.
timeFrame: Through study completion, an average of 1 year.
measure: Socio-economic status of study participant derived from Welsh Index of Multiple Deprivation (WIMD) using Postcode.
timeFrame: Through study completion, an average of 1 year.
measure: Alcohol consumption status of study participant at initial booking assessment and end of pregnancy. Self reported units consumed per week.
timeFrame: Through study completion, an average of 1 year.
measure: Substance misuse status at booking interview. Self reported recorded by Midwife.
timeFrame: Through study completion, an average of 1 year.
Locations:
city: Llantrisant
country: United Kingdom
facility: Royal Glamorgan Hospital
city: Merthyr Tydfil
country: United Kingdom
facility: Prince Charles Hospital
city: Mountain Ash
country: United Kingdom
facility: Ysbyty Cwm Cynon Hospital
city: Tonypandy
country: United Kingdom
facility: Ysbyty Cwm Rhondda Hospital
Study officials:
affiliation: Public Health Wales NHS Trust
name: Angela Jones
role: PRINCIPAL_INVESTIGATOR
affiliation: Public Health Wales NHS Trust
name: Angela Jones
role: STUDY_DIRECTOR
References: