Actively Recruiting

Phase Not Applicable
Age: 21Years - 40Years
FEMALE
Healthy Volunteers
ID05207059

Healthy Early Life Moments in Singapore: Integrated Care from Preconception to Postpartum for Overweight and Obese Women

Led by KK Women's and Children's Hospital · Updated on 2024-10-10

500

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

K

KK Women's and Children's Hospital

Lead Sponsor

L

Lien Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether a comprehensive care approach starting before pregnancy and continuing through maternity to the first 18 months of a child's life can improve metabolic and mental health for overweight and obese women, as well as health outcomes for their children. This research is conducted through the Healthy Early Life Moments in Singapore (HELMS) cohort at KK Women's and Children's Hospital, focusing on women aged 21 to 40 planning pregnancy. The study addresses challenges related to metabolic and mental health that affect mothers and their offspring, aiming to break cycles of obesity across generations. The intervention includes four modules: the HELMS Journey, providing guidance for study and clinic visits; the HELMS Model, which delivers a care plan focusing on screening, body size management, supplementation, and specific case management; the HELMS Lifestyle module, offering support on healthy eating, physical activity, sleep, and mental well-being; and the HELMS Connection, which fosters community support and engagement. Lifestyle support includes dietary guidance using the 6P tool, physical activity encouragement, and mental health promotion. Supplements such as multivitamins, vitamin D, calcium, and DHA are provided, tailored to different phases for both mother and child. Participants will be followed over five years, with assessments from preconception through pregnancy and up to 18 months postpartum. Evaluations include questionnaires, physical and biomarker tests, and collection of biosamples like blood, cord blood, and stool. Researchers will monitor pregnancy rates, maternal metabolic and mental health, and various maternal and offspring health indicators. The study also tracks adherence to the program and participant satisfaction. This detailed monitoring aims to understand the impact of the integrated care on mother and child health outcomes.

CONDITIONS

Brief Title

Healthy Early Life Moments in Singapore

Who Can Participate

Age: 21Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 21 to 40 years
  • Body mass index (BMI) between 25 and 40 kg/m2
  • Planning to conceive within 1 year
  • Intend to live in Singapore for the next 4 years
  • Chinese, Malay, Indian, or any combination of these ethnic groups
  • Able to understand English
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • Known type 1 or type 2 diabetes
  • Use of anticonvulsant medication in the past 1 month
  • Use of oral steroids in the past 1 month
  • Use of oral, implanted, or intrauterine contraceptives in the past 1 month
  • Use of fertility medications other than Clomiphene or Letrozole in the past 1 month
  • Use of HIV or Hepatitis B or C medication in the past 1 month

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Outpatient Treatment

Duration - Up to 40 months, from preconception through pregnancy and 18 months postpartum

Participants receive the HELMS Lifestyle Intervention, which includes health and risk assessments; education on weight management, healthy eating, physical activity, sleep, and mental well-being; supplementation; and specific case management from preconception through pregnancy to postpartum.

Regular visits throughout preconception, pregnancy, and postpartum periods

Postpartum Follow-up

Duration - Up to 18 months postpartum

Participants and their infants are monitored for ongoing health, growth, and development including infant feeding and gut microbiome assessments up to 18 months after birth.

Visits occurring from birth to infant age 18 months

Trial Site Locations

Total: 1 location

1

KK Women's and Children's Hospital

Singapore, Singapore, 229899

Actively Recruiting

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Research Team

X

Xiang Wen Ng, MPH

L

Lan Tian Lai, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Published Research Related To This Trial

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.

Jerry Kok Yen Chan, Chee Wai Ku, See Ling Loy...

https://pubmed.ncbi.nlm.nih.gov/36523242