Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2026-03-06 @ 11:16 AM
Study NCT ID:
NCT03875300
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-22
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Best Start - Weight Management During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079262', 'term': 'Pregnancy in Obesity'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011247', 'term': 'Pregnancy'}], 'ancestors': [{'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised Control Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 526}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2019-01-28', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'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.', 'description': 'Self reported and CO validated measurement of study participant smoking status at initial booking interview and self-reported at 36 weeks.'}, {'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.', 'description': 'Self reported assessment confirmed and recorded by Midwife.'}, {'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.', 'description': 'Socio-economic status assessed from WIMD category.'}, {'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.', 'description': 'Alcohol consumption status. At booking and end of pregnancy. Recorded by Midwife.'}, {'measure': 'Substance misuse status at booking interview. Self reported recorded by Midwife.', 'timeFrame': 'Through study completion, an average of 1 year.', 'description': 'Substance misuse status.'}], 'primaryOutcomes': [{'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.', 'description': 'Body Mass Index.'}, {'measure': 'Weight of participant recorded in kg at 36 weeks.', 'timeFrame': '36 weeks gestation.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of babies born Pre-term - babies born <37 weeks.', 'timeFrame': '<37 weeks gestation', 'description': 'Babies born to participants of the study at \\<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 +.', 'description': 'Participants will be monitored for signs of pre-eclampsia - hypertension and proteinuria.'}, {'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.', 'description': 'All participants will be monitored for VTE, DVT and PE in early pregnancy and again during the intrapartum and postpartum periods.'}, {'measure': 'Mode of delivery - Caesarean section.', 'timeFrame': 'Date of delivery.', 'description': 'Participants delivering by Caesarean section will be recorded.'}, {'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.', 'description': 'Signs of post post-surgical infections will be monitored and treated.'}, {'measure': 'Number of participants identified with Postpartum haemorrhage (PPH); Primary and Secondary.', 'timeFrame': '24 hours post-delivery to 12 weeks postpartum.', 'description': 'Participants will be monitored for signs of PPH.\n\nPPH can be broken down into stages:\n\nStage 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.'}, {'measure': 'Number of participants referred to the study.', 'timeFrame': 'July 2017-September 2018.', 'description': 'Number of obese pregnant women referred into the programme by their midwife.'}, {'measure': 'Number of participants Breastfeeding at birth, and exclusively breastfeeding at 10 days and 6 months.', 'timeFrame': 'Postnatal; Birth; 10 days and 6 months.', 'description': 'The number of study participants who breastfeed at birth, and exclusively breastfeed at 10 days and 6 months.'}, {'measure': 'Percentage of weight management programme sessions attended by participants.', 'timeFrame': 'Programme completion, an average of 7 weeks.', 'description': 'Uptake and acceptability of the programme to obese pregnant women measured through the percentage of weight management programme sessions attended.'}, {'measure': 'Number of post programme interviews/focus groups with eligible participants, following a scripted questionnaire.', 'timeFrame': 'Programme completion, an average of 7 weeks.', 'description': 'Uptake and acceptability of the programme to obese pregnant women measured through the number of post study interviews/focus groups with eligible participants.'}, {'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.', 'description': 'Self reported changes in nutrition knowledge, skills, physical activity levels, confidence and behaviour.'}, {'measure': 'Number of low birth weight babies born, weighing < 2.5kg.', 'timeFrame': 'At birth.', 'description': 'Weight of baby at birth lower than 2.5kg.'}, {'measure': 'Number of high birth weight babies born - Macrosomia.', 'timeFrame': 'At birth.', 'description': 'Weight of baby at birth higher than 3.99kg'}, {'measure': 'Number of Stillbirths.', 'timeFrame': '24 weeks gestation to date of delivery.', 'description': 'Stillbirth - Baby born dead after 24 weeks gestation.'}, {'measure': 'Number of Neonatal deaths.', 'timeFrame': 'Date of birth to 28 days.', 'description': 'Neonatal death - Death of a baby within the first 28 days of life.'}, {'measure': 'Number of babies born needing Transitional Care.', 'timeFrame': 'From birth to 14 days postpartum.', 'description': 'Babies born needing enhanced care but not Special Care Baby Unit (SCBU)admission.'}, {'measure': 'Number of babies born needing Neonatal intensive care unit (NICU) admission.', 'timeFrame': 'From birth to 14 days postpartum.', 'description': 'Babies born needing intensive care intervention.'}, {'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.', 'description': 'Rate of obesity measured at age 4-5 years, recorded as part of the Child Measurement Programme for Wales (All Wales Surveillance System).'}, {'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.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity in Pregnancy']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nBecause 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Aged over 16.\n* Capable of giving informed consent.\n* Singleton and multiple pregnancies.\n\nExclusion Criteria:\n\n* 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.\n* Aged under 16.\n* Incapable of giving informed consent.\n* Any women who have pre-existing diabetes, or develop gestational diabetes during their pregnancy.\n* 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)'}, 'identificationModule': {'nctId': 'NCT03875300', 'briefTitle': 'Best Start - Weight Management During Pregnancy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cwm Taf University Health Board (NHS)'}, 'officialTitle': 'Best Start - Weight Management During Pregnancy', 'orgStudyIdInfo': {'id': 'CwmTUHB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants in the Intervention Group', 'description': "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.", 'interventionNames': ['Behavioral: Foodwise in Pregnancy']}, {'type': 'NO_INTERVENTION', 'label': 'Participants in the Control Group', 'description': 'Control Group - will continue with routine antenatal care, unchanged.'}], 'interventions': [{'name': 'Foodwise in Pregnancy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Participants in the Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF72 8XR', 'city': 'Llantrisant', 'country': 'United Kingdom', 'facility': 'Royal Glamorgan Hospital', 'geoPoint': {'lat': 51.54028, 'lon': -3.37389}}, {'zip': 'CF47 9DT', 'city': 'Merthyr Tydfil', 'country': 'United Kingdom', 'facility': 'Prince Charles Hospital', 'geoPoint': {'lat': 51.74794, 'lon': -3.37779}}, {'zip': 'CF45 4BZ', 'city': 'Mountain Ash', 'country': 'United Kingdom', 'facility': 'Ysbyty Cwm Cynon Hospital', 'geoPoint': {'lat': 51.68361, 'lon': -3.38008}}, {'zip': 'CF40 2LX', 'city': 'Tonypandy', 'country': 'United Kingdom', 'facility': 'Ysbyty Cwm Rhondda Hospital', 'geoPoint': {'lat': 51.62202, 'lon': -3.45544}}], 'overallOfficials': [{'name': 'Angela Jones', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Public Health Wales NHS Trust'}, {'name': 'Angela Jones', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Public Health Wales NHS Trust'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'It is anticipated that the initial study findings will be available for dissemination by approximately January 2021.\n\nThe final Statistical Analysis Plan (SAP) is still to be determined.', 'ipdSharing': 'YES', '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.\n\nThe 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.', 'accessCriteria': 'Access criteria is still to be determined.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cwm Taf University Health Board (NHS)', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Burdett Trust for Nursing', 'class': 'OTHER'}, {'name': 'Public Health Wales NHS Trust', 'class': 'UNKNOWN'}, {'name': 'Swansea University', 'class': 'OTHER'}, {'name': 'Cardiff Metropolitan University', 'class': 'OTHER'}, {'name': 'Cardiff University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}