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Active, Not Recruiting

NCT Number: NCT03875300

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity in Pregnancy Body Weight Female Urogenital Diseases and Pregnancy Complications Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Obesity Signs and Symptoms Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Glamorgan Hospital, Llantrisant, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Foodwise in Pregnancy

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Number of babies born Pre-term - babies born <37 weeks.

    Time frame: <37 weeks gestation

    Babies born to participants of the study at <37 weeks gestation.

  2. Number of participants identified with Pre-eclampsia - New hypertension presenting after 20 weeks of pregnancy with significant proteinuria.

    Time frame: 20 weeks +.

    Participants will be monitored for signs of pre-eclampsia - hypertension and proteinuria.

  3. 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.

    All participants will be monitored for VTE, DVT and PE in early pregnancy and again during the intrapartum and postpartum periods.

  4. Mode of delivery - Caesarean section.

    Time frame: Date of delivery.

    Participants delivering by Caesarean section will be recorded.

  5. 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.

    Signs of post post-surgical infections will be monitored and treated.

  6. Number of participants identified with Postpartum haemorrhage (PPH); Primary and Secondary.

    Time frame: 24 hours post-delivery to 12 weeks postpartum.

    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.

  7. Number of participants referred to the study.

    Time frame: July 2017-September 2018.

    Number of obese pregnant women referred into the programme by their midwife.

  8. Number of participants Breastfeeding at birth, and exclusively breastfeeding at 10 days and 6 months.

    Time frame: Postnatal; Birth; 10 days and 6 months.

    The number of study participants who breastfeed at birth, and exclusively breastfeed at 10 days and 6 months.

  9. Percentage of weight management programme sessions attended by participants.

    Time frame: Programme completion, an average of 7 weeks.

    Uptake and acceptability of the programme to obese pregnant women measured through the percentage of weight management programme sessions attended.

  10. Number of post programme interviews/focus groups with eligible participants, following a scripted questionnaire.

    Time frame: Programme completion, an average of 7 weeks.

    Uptake and acceptability of the programme to obese pregnant women measured through the number of post study interviews/focus groups with eligible participants.

  11. 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.

    Self reported changes in nutrition knowledge, skills, physical activity levels, confidence and behaviour.

  12. Number of low birth weight babies born, weighing < 2.5kg.

    Time frame: At birth.

    Weight of baby at birth lower than 2.5kg.

  13. Number of high birth weight babies born - Macrosomia.

    Time frame: At birth.

    Weight of baby at birth higher than 3.99kg

  14. Number of Stillbirths.

    Time frame: 24 weeks gestation to date of delivery.

    Stillbirth - Baby born dead after 24 weeks gestation.

  15. Number of Neonatal deaths.

    Time frame: Date of birth to 28 days.

    Neonatal death - Death of a baby within the first 28 days of life.

  16. Number of babies born needing Transitional Care.

    Time frame: From birth to 14 days postpartum.

    Babies born needing enhanced care but not Special Care Baby Unit (SCBU)admission.

  17. Number of babies born needing Neonatal intensive care unit (NICU) admission.

    Time frame: From birth to 14 days postpartum.

    Babies born needing intensive care intervention.

  18. 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.

    Rate of obesity measured at age 4-5 years, recorded as part of the Child Measurement Programme for Wales (All Wales Surveillance System).

  19. 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.

    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.

Other outcomes

  1. Smoking status of study participant. Self reported measure and confirmed using piCObaby Smokerlyzer CO parts per million (PPM).

    Time frame: Through study completion, an average of 1 year.

    Self reported and CO validated measurement of study participant smoking status at initial booking interview and self-reported at 36 weeks.

  2. 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.

    Time frame: Through study completion, an average of 1 year.

    Self reported assessment confirmed and recorded by Midwife.

  3. Socio-economic status of study participant derived from Welsh Index of Multiple Deprivation (WIMD) using Postcode.

    Time frame: Through study completion, an average of 1 year.

    Socio-economic status assessed from WIMD category.

  4. Alcohol consumption status of study participant at initial booking assessment and end of pregnancy. Self reported units consumed per week.

    Time frame: Through study completion, an average of 1 year.

    Alcohol consumption status. At booking and end of pregnancy. Recorded by Midwife.

  5. Substance misuse status at booking interview. Self reported recorded by Midwife.

    Time frame: Through study completion, an average of 1 year.

    Substance misuse status.

Sponsors and collaborators

Lead sponsor

Cwm Taf University Health Board (NHS)

Other Gov

Collaborators

  • Burdett Trust for Nursing
  • Cardiff Metropolitan University
  • Cardiff University
  • Public Health Wales
  • Swansea University

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2027
First posted
Mar 14, 2019
Registry last updated
Aug 22, 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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