Healthy Early Life Moments in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Pregnancy rate
研究概览
简要总结
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.
详细描述
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.
HELMS 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.
Through 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 21-40 years
- •BMI 25-40 kg/m2
- •Intention to reside in Singapore for the next 4 years
- •Chinese, Malay, Indian or any combination of these 3 ethnic groups
- •Planning to conceive within 1 year
- •Able to understand English
- •Able to provide written, informed consent
排除标准
- •Currently pregnant
- •Known type 1 or type 2 diabetes
- •On any anticonvulsant medication in the past 1 month
- •On any oral steroid in the past 1 month (e.g. Prednisolone, Prednisone, Deltasone, Prelone, Methyl Prednisolone, Medrol, Hydrocortisone, Cortef, Dexamethasone, Decadron)
- •On any oral, implanted contraception or intrauterine contraceptive device (IUCD) in situ in the past 1 month
- •On any fertility medication (e.g. hormones injection, IVF treatments) other than Clomiphene/ Letrozole in the past 1 month
- •On HIV or Hepatitis B or C medication in the past 1 month.
研究组 & 干预措施
Study Arm
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.
干预措施: HELMS Lifestyle Intervention (Behavioral)
结局指标
主要结局
Pregnancy rate
时间窗: Up to 12 months
Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages
Maternal metabolic health
时间窗: Up to 40 months, between preconception, pregnancy and 18 months postpartum
Evaluated by metabolic syndrome criteria
Maternal mental health
时间窗: Up to 26 months, between preconception, pregnancy and 4 months postpartum
Measured by Edinburgh Postnatal Depression Scale, scored between 0 to 30, with a higher score being suggestive of depression
次要结局
- Maternal ocular health(Up to 21 months, from preconception until 36 weeks gestation)
- Maternal abdominal fat(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Fecundability(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))
- Female sexual function(Up to 3 months, between date of recruitment and 3 months preconception follow-up)
- Pregnancy loss rate(Up to 42 weeks, between date of conception and date of delivery)
- Live birth rates(Up to 42 weeks, between date of conception and date of delivery)
- Maternal lipid levels(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal glycaemic marker - plasma glucose(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal glycaemic marker - HbA1c(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal glycaemic marker - C-peptide(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal glycaemic markers - Insulin(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal glucose tolerance status(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal blood pressure(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal heart rate(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal body weight(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal body weight status(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal body fat distribution(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal body composition(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal body fat mass(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal visceral fat(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal body lean mass(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal nutrient intake(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal food intake(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal food intakes(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal dietary pattern(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal food timing(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal eating episodes(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal dietary behaviour - 6P(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal dietary behaviour - TFEQ(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal micronutrient status(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal physical activity level - self assessment(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal physical activity(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal sedentary behaviour - self assessment(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal sedentary behaviour(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal sleep - PSQI(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal sleep(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal emotional wellbeing(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Maternal personality trait(At preconception)
- Duration of gestation(Up to 42 weeks, between estimated date of conception from menstrual and ultrasound scan and date of delivery)
- Number of participants with gestational diabetes(Up to 20 weeks, between 12 and 32 weeks gestation)
- Number of participants with hypertensive disorders of pregnancy(Up to 42 weeks, between date of conception and date of delivery)
- Mode of labour onset, course of delivery and delivery outcomes(Delivery)
- Maternal pain(Up to 5 months, between 32 weeks gestation and 6-8 weeks post-delivery)
- Antenatal, perinatal and postnatal complications(Up to 50 weeks, between date of conception and up to 8 weeks postpartum)
- Neonatal complications and admission to neonatal care facilities(Up to 4 weeks, between date of delivery and 4 weeks post-delivery)
- Offspring body weight(Up to 18 months, from birth to infant age 18 months)
- Offspring body size at birth(At birth)
- Offspring body length(Up to 18 months, from birth to infant age 18 months)
- Offspring head circumference(Up to 18 months, from birth to infant age 18 months)
- Intrauterine growth of foetus(Up to 30 weeks, between 7 weeks gestation and 37 weeks of gestation)
- Offspring feeding(Up to 18 months, from birth to infant age 18 months)
- Offspring gut microbiome(Up to 18 months, from birth to infant age 18 months)
- Maternal gut microbiome(Up to 24 months, between preconception, pregnancy and 2 months postpartum)
- Influence of parental and offspring genotypes, body compositions, lifestyle and diet on the above primary and secondary outcomes(Up to 40 months, between preconception, pregnancy and 18 months postpartum)
- Acceptability and adherence levels(Up to 40 months, at preconception, pregnancy and 18 months postpartum)
- Satisfactory level of participants with the HELMS program(Up to 40 months, at preconception, pregnancy and 18 months postpartum)