Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-27 @ 8:04 PM
Study NCT ID:
NCT05207059
Status:
RECRUITING
Last Update Posted:
2024-10-10
First Post:
2021-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Early Life Moments in Singapore
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}, {'id': 'D000079262', 'term': 'Pregnancy in Obesity'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'HELMS is conceptualised as a single-arm implementation pilot trial, where lifestyle interventions are implemented in overweight or obese women from preconception to pregnancy and postpartum periods. We will follow both mother and child up to 18 months after delivery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2022-01-11', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health economics analysis of the HELMS program', 'timeFrame': 'Composite analysis between preconception visit which is up to 12 months before pregnancy and until infant age 18 months', 'description': 'Cost benefit analysis from health expenses and diseases outcomes'}, {'measure': 'Maternal general health and wellbeing', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From questionnaire, expressed in percentages'}, {'measure': 'Offspring health and general wellbeing', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'From questionnaire and/or medical records, expressed in percentages'}, {'measure': 'Offspring metabolomic profile', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'From cord blood, placenta, infant blood and/or skin biopsy'}, {'measure': 'Offspring genomic profile', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'From cord blood, placenta, infant blood and/or skin biopsy'}, {'measure': 'Offspring epigenetic profile', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'From cord blood, placenta, infant blood and/or skin biopsy'}, {'measure': 'Offspring biochemical profile', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'From cord blood, placenta, infant blood and/or skin biopsy'}, {'measure': 'Offspring metabolic profile', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'From cord blood, placenta, infant blood and/or skin biopsy'}, {'measure': 'Offspring immunological profile', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'From cord blood, placenta, infant blood and/or skin biopsy'}, {'measure': 'Offspring molecular profile', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'From cord blood, placenta, infant blood and/or skin biopsy'}, {'measure': 'Maternal metabolomic profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood, urine and/or saliva samples'}, {'measure': 'Maternal genomic profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood, urine and/or saliva samples'}, {'measure': 'Maternal epigenetic profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood, urine and/or saliva samples'}, {'measure': 'Maternal temperature', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by skin temperature sensor, in degree celsius'}, {'measure': 'Maternal biochemical profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood, urine and/or saliva samples'}, {'measure': 'Maternal metabolic profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood, urine and/or saliva samples'}, {'measure': 'Maternal immunological profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood, urine and/or saliva samples'}, {'measure': 'Maternal molecular profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood, urine and/or saliva samples'}, {'measure': 'Paternal body weight', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by weighing scale, in kilograms'}, {'measure': 'Paternal body weight status', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined by body mass index based on weight (kg) /height (m)2'}, {'measure': 'Paternal body fat distribution', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from waist hip circumferences in centimetres'}, {'measure': 'Paternal abdominal fat', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from waist hip circumferences in ratio'}, {'measure': 'Paternal body composition', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from body fat analysis in percentages'}, {'measure': 'Paternal body fat mass', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from body fat analysis in percentages'}, {'measure': 'Paternal body lean mass', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from body fat analysis in percentages'}, {'measure': 'Paternal body visceral fat', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from body fat analysis in percentages'}, {'measure': 'Paternal health and general well-being - self assessment', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From questionnaires'}, {'measure': 'Paternal health and general well-being', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From digital sensor'}, {'measure': 'Paternal immunological profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood and/or urine samples'}, {'measure': 'Paternal biochemical profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood and/or urine samples'}, {'measure': 'Paternal metabolic profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood and/or urine samples'}, {'measure': 'Paternal molecular profile', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'From blood and/or urine samples'}, {'measure': 'Breast milk macronutrient profile (subsample)', 'timeFrame': 'Up to 1 year, between date of delivery and 1 year postpartum', 'description': 'From breast milk sample'}, {'measure': 'Breast milk micronutrient profile (subsample)', 'timeFrame': 'Up to 1 year, between date of delivery and 1 year postpartum', 'description': 'From breast milk sample'}, {'measure': 'Breast milk immune factor profile (subsample)', 'timeFrame': 'Up to 1 year, between date of delivery and 1 year postpartum', 'description': 'From breast milk sample'}, {'measure': 'Breast milk epigenetic profile (subsample)', 'timeFrame': 'Up to 1 year, between date of delivery and 1 year postpartum', 'description': 'From breast milk sample'}, {'measure': 'Breast milk biochemical profile (subsample)', 'timeFrame': 'Up to 1 year, between date of delivery and 1 year postpartum', 'description': 'From breast milk sample'}, {'measure': 'Breast milk metabolic profile (subsample)', 'timeFrame': 'Up to 1 year, between date of delivery and 1 year postpartum', 'description': 'From breast milk sample'}, {'measure': 'Breast milk microbiome profile (subsample)', 'timeFrame': 'Up to 1 year, between date of delivery and 1 year postpartum', 'description': 'From breast milk sample'}, {'measure': 'Breast milk molecular profile (subsample)', 'timeFrame': 'Up to 1 year, between date of delivery and 1 year postpartum', 'description': 'From breast milk sample'}, {'measure': 'Maternal transcriptomics', 'timeFrame': 'Up to 36 months, between preconception, pregnancy and 1 year postpartum', 'description': 'From blood and/or breast milk samples'}, {'measure': 'Infant transcriptomics', 'timeFrame': 'Up to 36 months, between preconception, pregnancy and 1 year postpartum', 'description': 'From blood'}], 'primaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': 'Up to 12 months', 'description': 'Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages'}, {'measure': 'Maternal metabolic health', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Evaluated by metabolic syndrome criteria'}, {'measure': 'Maternal mental health', 'timeFrame': 'Up to 26 months, between preconception, pregnancy and 4 months postpartum', 'description': 'Measured by Edinburgh Postnatal Depression Scale, scored between 0 to 30, with a higher score being suggestive of depression'}], 'secondaryOutcomes': [{'measure': 'Fecundability', 'timeFrame': 'Up to 12 months, between dates of last menstrual period at recruitment and before conception (for pregnant women) or last follow-up call (for non-pregnant women)', 'description': 'Measured by time to pregnancy in total discrete cycles at risk of pregnancy'}, {'measure': 'Female sexual function', 'timeFrame': 'Up to 3 months, between date of recruitment and 3 months preconception follow-up', 'description': 'Measured by Female Sexual Function Index, with a higher score being suggestive of better sexual function'}, {'measure': 'Pregnancy loss rate', 'timeFrame': 'Up to 42 weeks, between date of conception and date of delivery', 'description': 'Based on ultrasound scan and medical records, in percentage'}, {'measure': 'Live birth rates', 'timeFrame': 'Up to 42 weeks, between date of conception and date of delivery', 'description': 'Based on ultrasound scan and medical records, in percentage'}, {'measure': 'Maternal lipid levels', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Including total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, in mmol/L'}, {'measure': 'Maternal glycaemic marker - plasma glucose', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by plasma glucose levels, in mmol/L'}, {'measure': 'Maternal glycaemic marker - HbA1c', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by HbA1c, in percentage'}, {'measure': 'Maternal glycaemic marker - C-peptide', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by C-peptide, in SI unit'}, {'measure': 'Maternal glycaemic markers - Insulin', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by serum insulin, in SI unit'}, {'measure': 'Maternal glucose tolerance status', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by Oral Glucose Tolerance Test (OGTT), in mmol/L'}, {'measure': 'Maternal blood pressure', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by blood pressure device for systolic and diastolic pressures in mmHg'}, {'measure': 'Maternal heart rate', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by blood pressure device or sensor in beats per minutes'}, {'measure': 'Maternal body weight', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by weighing scale in kilograms'}, {'measure': 'Maternal body weight status', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined by body mass index based on weight (kg) /height (m)2'}, {'measure': 'Maternal body fat distribution', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from waist hip circumferences in centimeters'}, {'measure': 'Maternal abdominal fat', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from waist hip circumferences in ratio'}, {'measure': 'Maternal body composition', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from body fat analysis in percentages'}, {'measure': 'Maternal body fat mass', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from body fat analysis in percentages'}, {'measure': 'Maternal visceral fat', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from body fat analysis in volumes'}, {'measure': 'Maternal body lean mass', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Determined from body fat analysis in percentages'}, {'measure': 'Maternal nutrient intake', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by food diary and/or food frequency questionnaire in SI units of respective nutrients'}, {'measure': 'Maternal food intake', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by food diary and/or food frequency questionnaire in serving sizes'}, {'measure': 'Maternal food intakes', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by food diary and/or food frequency questionnaire in grams'}, {'measure': 'Maternal dietary pattern', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by food diary and/or food frequency questionnaire using factor loading analysis'}, {'measure': 'Maternal food timing', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by food diary in time phase'}, {'measure': 'Maternal eating episodes', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by food diary in eating frequency'}, {'measure': 'Maternal dietary behaviour - 6P', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by 6P Questionnaire based on each factor in the questionnaire'}, {'measure': 'Maternal dietary behaviour - TFEQ', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by Three Factor Eating Questionnaire, based on the scores from each category'}, {'measure': 'Maternal micronutrient status', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Micronutrient panel from plasma or breastmilk such as 1-carbon metabolites, vitamin D and E, expressed in SI units of respective micronutrients'}, {'measure': 'Maternal physical activity level - self assessment', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by International Physical Activity Questionnaire, with a higher score suggesting higher physical activity level'}, {'measure': 'Maternal physical activity', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by accelerometer and/or digital sensor, in respective SI units'}, {'measure': 'Maternal sedentary behaviour - self assessment', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by sedentary behaviour questionnaire, in hours and minutes per day, with longer duration suggestive of greater sedentary behaviour'}, {'measure': 'Maternal sedentary behaviour', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by accelerometer and/or digital sensor, in respective SI units'}, {'measure': 'Maternal sleep - PSQI', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by Pittsburgh Sleep Quality Index, scored from 0-21, with higher score suggestive of poor sleep quality'}, {'measure': 'Maternal sleep', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by accelerometer and/or digital sensor, in respective SI units'}, {'measure': 'Maternal emotional wellbeing', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by questionnaires'}, {'measure': 'Maternal ocular health', 'timeFrame': 'Up to 21 months, from preconception until 36 weeks gestation', 'description': 'Measured by retinal vessel characteristics (including vessel caliber, geometric assessment and vasoreactivity)'}, {'measure': 'Maternal ocular health', 'timeFrame': 'Up to 21 months, from preconception until 36 weeks gestation', 'description': 'Measured by retinal and choroidal characteristics using three-dimensional volumetric (OCT-A) imaging systems'}, {'measure': 'Maternal personality trait', 'timeFrame': 'At preconception', 'description': 'Measured by M5-50 questionnaire, with classification into respective personality types'}, {'measure': 'Duration of gestation', 'timeFrame': 'Up to 42 weeks, between estimated date of conception from menstrual and ultrasound scan and date of delivery', 'description': 'Defined as the length of pregnancy, in months and days'}, {'measure': 'Number of participants with gestational diabetes', 'timeFrame': 'Up to 20 weeks, between 12 and 32 weeks gestation', 'description': 'Determined by oral glucose tolerance test during pregnancy'}, {'measure': 'Number of participants with hypertensive disorders of pregnancy', 'timeFrame': 'Up to 42 weeks, between date of conception and date of delivery', 'description': 'Including pregnancy-induced hypertension and pre-eclampsia/eclampsia from questionnaire and/or retrieved from medical records'}, {'measure': 'Mode of labour onset, course of delivery and delivery outcomes', 'timeFrame': 'Delivery', 'description': 'From questionnaire and/or retrieved from medical records, reported in percentages'}, {'measure': 'Maternal pain', 'timeFrame': 'Up to 5 months, between 32 weeks gestation and 6-8 weeks post-delivery', 'description': 'Measured by pain questionnaire'}, {'measure': 'Antenatal, perinatal and postnatal complications', 'timeFrame': 'Up to 50 weeks, between date of conception and up to 8 weeks postpartum', 'description': 'From questionnaire and/or retrieved from medical records, reported in percentages'}, {'measure': 'Neonatal complications and admission to neonatal care facilities', 'timeFrame': 'Up to 4 weeks, between date of delivery and 4 weeks post-delivery', 'description': 'From questionnaire and/or retrieved from medical records, reported in percentages'}, {'measure': 'Offspring body weight', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'Weight measured in grams'}, {'measure': 'Offspring body size at birth', 'timeFrame': 'At birth', 'description': 'Adjusted for gestational age and sex, expressed in percentile'}, {'measure': 'Offspring body length', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'Measured in centimeters'}, {'measure': 'Offspring head circumference', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'Measured in centimeters'}, {'measure': 'Intrauterine growth of foetus', 'timeFrame': 'Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation', 'description': 'As assessed by antenatal serial ultrasound scans to determine head and abdominal circumference, femur length and estimated foetal weight'}, {'measure': 'Offspring feeding', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'Measured types of feeding using questionnaires'}, {'measure': 'Offspring gut microbiome', 'timeFrame': 'Up to 18 months, from birth to infant age 18 months', 'description': 'Measured from stool samples'}, {'measure': 'Maternal gut microbiome', 'timeFrame': 'Up to 24 months, between preconception, pregnancy and 2 months postpartum', 'description': 'Measured from stool samples'}, {'measure': 'Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes', 'timeFrame': 'Up to 40 months, between preconception, pregnancy and 18 months postpartum', 'description': 'Measured by questionnaires, accelerometer, digital sensor and/or biomarkers'}, {'measure': 'Acceptability and adherence levels', 'timeFrame': 'Up to 40 months, at preconception, pregnancy and 18 months postpartum', 'description': 'From questionnaire, with higher score indicates higher acceptability and adherence'}, {'measure': 'Satisfactory level of participants with the HELMS program', 'timeFrame': 'Up to 40 months, at preconception, pregnancy and 18 months postpartum', 'description': 'From patient satisfaction questionnaire in a Likert scale, with a higher score suggesting greater satisfaction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Mental health', 'Lifestyle intervention'], 'conditions': ['Metabolic Disease', 'Mental Health Wellness 1', 'Lifestyle Risk Reduction', 'Maternal Obesity']}, 'referencesModule': {'references': [{'pmid': '36523242', 'type': 'DERIVED', 'citation': 'Chan JKY, Ku CW, Loy SL, Godfrey KM, Fan Y, Chua MC, Yap F. Effects of an integrated mobile health lifestyle intervention among overweight and obese women planning for pregnancy in Singapore: protocol for the single-arm healthy early life moments in Singapore (HELMS) study. BMJ Open. 2022 Dec 12;12(12):e061556. doi: 10.1136/bmjopen-2022-061556.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess whether an integrated continuum of care from the preconception period, across maternity until the first 18 months of life, can promote maternal metabolic and mental health, as well as offspring health, among overweight and obese women.', 'detailedDescription': "Maternal Child Health (MCH) in Singapore is currently entering a new phase to address the twin challenges; a burgeoning (i) Metabolic and (ii) Mental Health Challenge for Singapore which have shown to have adverse effects on childbearing and child outcomes. To tackle these challenges, we are establishing a new Model-of-Care (MOC) with a life-course approach at KK Women's and Children's Hospital (KKH) through the Healthy Early Life Moments in Singapore (HELMS) cohort. Over the course of five years, HELMS will enroll 500 overweight or obese women aged 21-40 years planning for pregnancy, with an estimated 170 completing their pregnancies where they will be followed for another 18 months as a mother-child dyad.\n\nHELMS leverages on building a healthy mental model of life-course events through preconception to postpartum life. Components of intervention will focus on preconception-pregnancy-postpartum care and lifestyle guidance on diet, physical activity, emotion and sleep, complemented by health nudges to promote sustainable change. Various questionnaires and testing will be carried out at relevant time points. Biosamples including blood, cord blood and stool will be collected.\n\nThrough the application of HELMS, there is potential to improve metabolic and mental health, break vicious transgenerational cycles of obesity transmission and promote virtuous life cycles of health in the population."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women aged 21-40 years\n2. BMI 25-40 kg/m2\n3. Intention to reside in Singapore for the next 4 years\n4. Chinese, Malay, Indian or any combination of these 3 ethnic groups\n5. Planning to conceive within 1 year\n6. Able to understand English\n7. Able to provide written, informed consent\n\nExclusion Criteria:\n\n1. Currently pregnant\n2. Known type 1 or type 2 diabetes\n3. On any anticonvulsant medication in the past 1 month\n4. On any oral steroid in the past 1 month (e.g. Prednisolone, Prednisone, Deltasone, Prelone, Methyl Prednisolone, Medrol, Hydrocortisone, Cortef, Dexamethasone, Decadron)\n5. On any oral, implanted contraception or intrauterine contraceptive device (IUCD) in situ in the past 1 month\n6. On any fertility medication (e.g. hormones injection, IVF treatments) other than Clomiphene/ Letrozole in the past 1 month\n7. On HIV or Hepatitis B or C medication in the past 1 month.'}, 'identificationModule': {'nctId': 'NCT05207059', 'acronym': 'HELMS', 'briefTitle': 'Healthy Early Life Moments in Singapore', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'Healthy Early Life Moments in Singapore', 'orgStudyIdInfo': {'id': '2021/2247'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Arm', 'description': "The intervention will comprise four modules, namely the HELMS Journey, HELMS Model, HELMS Lifestyle and HELMS Community. The HELMS Journey will provide anticipatory guidance for both HELMS and routine clinic visits. The HELMS Model will deliver the 4S ('Screening', 'Size', 'Supplementation' and 'Specific case management') care plan, detailed below. The HELMS Lifestyle will provide lifestyle support in terms of healthy eating through the 6P tool ('Portion', 'Proportion', 'Pleasure', 'Phase', Physicality', 'Psychology'), physical activity, sleep and mental well-being. Finally, the HELMS Connection will provide community support and improve engagement with the program.", 'interventionNames': ['Behavioral: HELMS Lifestyle Intervention']}], 'interventions': [{'name': 'HELMS Lifestyle Intervention', 'type': 'BEHAVIORAL', 'description': "The HELMS life-course Interventions, namely 4S ('Screening', 'Size', 'Supplementation' and 'Specific case management'), are developed to deliver care throughout the journey from preconception to postpartum periods. Screening involves health and risk assessments through physical and biomarker measurements, as well as emotion and sleep evaluations for mother, and developmental assessment for children. Body Size management encompasses education on weight status awareness and mother-child health implications, both mother-child weight tracking, healthy eating and physical activity guidance. Supplementation includes multi-micronutrient, vitamin D, calcium and/or Docosahexaenoic acid (DHA) supplements, which is phase-specific for mother, and vitamin D drops supplement for child. Specific case management comprises preconception sexual health and function management, pregnancy symptoms management, postpartum recovery management, infant growth monitoring and feeding management.", 'armGroupLabels': ['Study Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '229899', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Lan Tian Lai, MSc', 'role': 'CONTACT', 'email': 'lai.lan.tian@kkh.com.sg'}], 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Xiang Wen Ng, MPH', 'role': 'CONTACT', 'email': 'ng.xiang.wen@kkh.com.sg', 'phone': '+65 6394 8113'}, {'name': 'Lan Tian Lai, MSc', 'role': 'CONTACT', 'email': 'lai.lan.tian@kkh.com.sg'}], 'overallOfficials': [{'name': 'Jerry Chan, MB BCh BaO MA FRCOG PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Lien Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}