Healthy Early Life Moments in Singapore

NCT05207059 | Recruiting

• 1 other identifier: 2021/2247
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Disease; Mental Health Wellness 1; Lifestyle Risk Reduction; Maternal Obesity

Keywords

Obesity; Mental health; Lifestyle intervention

Outcome Measures

Primary Outcomes (3)

• Pregnancy rate

  Defined by positive urine pregnancy test, clinical diagnosis and/or ultrasound scan showing intrauterine gestation sac, in percentages

  Up to 12 months

• Maternal metabolic health

  Evaluated by metabolic syndrome criteria

  Up to 40 months, between preconception, pregnancy and 18 months postpartum

• Maternal mental health

  Measured by Edinburgh Postnatal Depression Scale, scored between 0 to 30, with a higher score being suggestive of depression

  Up to 26 months, between preconception, pregnancy and 4 months postpartum

Secondary Outcomes (57)

• 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

Other Outcomes (42)

• Health economics analysis of the HELMS program

  Composite analysis between preconception visit which is up to 12 months before pregnancy and until infant age 18 months

• Maternal general health and wellbeing

  Up to 40 months, between preconception, pregnancy and 18 months postpartum

• Offspring health and general wellbeing

  Up to 18 months, from birth to infant age 18 months

Study Arms (1)

Study Arm

EXPERIMENTAL

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.

Behavioral: HELMS Lifestyle Intervention

Interventions

HELMS Lifestyle Intervention BEHAVIORAL

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.

Study Arm

Eligibility Criteria

• Age: 21 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Lien Foundation: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 36523242 DERIVED

MeSH Terms

Conditions

Metabolic Diseases; Risk Reduction Behavior; Pregnancy in Obesity; Obesity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Behavior; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Jerry Chan, MB BCh BaO MA FRCOG PhD

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang Wen Ng, MPH

CONTACT

+65 6394 8113; ng.xiang.wen@kkh.com.sg

Lan Tian Lai, MSc

CONTACT

lai.lan.tian@kkh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 26, 2022
• Study Start: March 18, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)