Anthropometric Outcomes of a Mobile Health Intervention for Eating Behaviour and Lifestyle in Infancy

NCT06457750 | Not Yet Recruiting

• 1 other identifier: AM/TP081/2024 (SRDUKAMR2481)
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

Lifestyle, activity, and feeding behaviours during early childhood set the foundation for subsequent lifelong metabolic health as an adult. The investigators have developed a digital tool, called Feeding, Lifestyle, Activity Goals (FLAGs) to assess lifestyle and feeding behaviours of young infants, simultaneously providing guidance and tailored advice for parents on ideal practices specific to their children. The investigators aim to assess its usability, acceptability, and feasibility , before proceeding to determine efficacy of the FLAGs intervention through conducting a randomized controlled trial, enrolling 440 infants from KK Women's and Children's Hospital. Half of them will receive standard routine infant care, whereas the other half will additionally receive the digital FLAGs assessment and advisory tool, complete with mobile nudges. The follow-up period will be over 12 months, with the main outcomes being i) indicators of good feeding and lifestyle behaviour at 12 months old, and ii) physical growth trends, body fat proportions. Demonstrating the benefits of using FLAGs will underscore the importance of integrating this digitalized tool into the screening and evaluation of well children, with the potential to be upscaled and adopted across hospitals, primary care, and community-based health programmes.

Conditions

Childhood Obesity Prevention

Keywords

Developmental origins of health and disease; childhood obesity; life course approach; population health; paediatrics

Outcome Measures

Primary Outcomes (5)

• Longitudinal growth trajectories and markers of infant metabolic health

  Weight (kilograms)

  12 months from recruitment

• Longitudinal growth trajectories and markers of infant metabolic health

  Length (meters)

  12 months from recruitment

• Longitudinal growth trajectories and markers of infant metabolic health

  Body mass index (kg/m\^2) will be determined by taking the weight (kilograms) divided by the squared value of the length (meters).

  12 months from recruitment

• Longitudinal growth trajectories and markers of infant metabolic health

  Weight for length percentile (%) will be determined using the WHO 2006 Child Growth Standards

  12 months from recruitment

• Longitudinal growth trajectories and markers of infant metabolic health

  Body composition, using skinfold thickness measurements (centimeters)

  12 months from recruitment

Secondary Outcomes (4)

• Indicators of good feeding and lifestyle behaviour

  12 months from recruitment

• Indicators of good feeding and lifestyle behaviour

  12 months from recruitment

• Indicators of good feeding and lifestyle behaviour

  12 months from recruitment

• Indicators of good feeding and lifestyle behaviour

  12 months from recruitment

Study Arms (2)

Intervention Arm (Exposed to FLAGs Digital Health Application)

EXPERIMENTAL

Participants in the intervention group will have access to the FLAGs assessment tool together with the real-time feedback and advisory provided by the digital application, complete with mobile nudges.

Behavioral: Feeding, Lifestyle, Activity Goals (FLAGs) Digital Health Application

Control Arm

NO INTERVENTION

Participants in the control group will not have access to the FLAGs advisory and monitoring functions will not be made available on their digital application. Participants will not receive any automated notifications or nudges.

Interventions

Feeding, Lifestyle, Activity Goals (FLAGs) Digital Health Application BEHAVIORAL

Feeding, lifestyle, activity goals (FLAGs) is a digital assessment and advisory tool developed by the investigators to facilitate early identification of lifestyle behaviour problems and abnormal feeding patterns in infants, with real-time feedback for caregivers. The FLAGs questionnaire examines the domains of energy regulation, timeliness and adequacy of weaning, dietary practices, and lifestyle habits. Tailored recommendations have been developed for each domain accordingly. The objective of FLAGs is shaping healthy lifestyle and feeding behaviours from birth, charting a trajectory to optimal metabolic health.

Intervention Arm (Exposed to FLAGs Digital Health Application)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• weeks' pregnant, or 3 days post-delivery.
• Pre-pregnancy BMI of at least 23 kg/m\^2, and/or with the diagnosis of gestational diabetes mellitus or type 2 diabetes mellitus.

You may not qualify if:

• Women less than 21 years old
• Unable to understand English
• Not planning to reside in Singapore until baby is at least 1 year old
• Premature birth of baby (defined as below 37 weeks' gestation)
• Birth of a baby with congenital abnormalities, physical or neurodevelopmental disabilities

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore, 229899, Singapore

Location

Related Publications (6)

• NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017 Dec 16;390(10113):2627-2642. doi: 10.1016/S0140-6736(17)32129-3. Epub 2017 Oct 10.

  PMID: 29029897 BACKGROUND

• Singh AS, Mulder C, Twisk JW, van Mechelen W, Chinapaw MJ. Tracking of childhood overweight into adulthood: a systematic review of the literature. Obes Rev. 2008 Sep;9(5):474-88. doi: 10.1111/j.1467-789X.2008.00475.x. Epub 2008 Mar 5.

  PMID: 18331423 BACKGROUND

• Scott JA. The first 1000 days: A critical period of nutritional opportunity and vulnerability. Nutr Diet. 2020 Jul;77(3):295-297. doi: 10.1111/1747-0080.12617. No abstract available.

  PMID: 32478460 BACKGROUND

• Kouvari M, Karipidou M, Tsiampalis T, Mamalaki E, Poulimeneas D, Bathrellou E, Panagiotakos D, Yannakoulia M. Digital Health Interventions for Weight Management in Children and Adolescents: Systematic Review and Meta-analysis. J Med Internet Res. 2022 Feb 14;24(2):e30675. doi: 10.2196/30675.

  PMID: 35156934 BACKGROUND

• Tanrikulu MA, Agirbasli M, Berenson G. Primordial Prevention of Cardiometabolic Risk in Childhood. Adv Exp Med Biol. 2017;956:489-496. doi: 10.1007/5584_2016_172.

  PMID: 27864799 BACKGROUND

• Chan D, Leong K, Ong C, Ku CW, Chan JKY, Chua MC, Yap F, Loy SL. Efficacy of a mobile app-based intervention to improve eating behaviours and lifestyle in infants of mothers with metabolic risk factors: study protocol of a randomised controlled trial. BMJ Open. 2025 Sep 30;15(9):e101684. doi: 10.1136/bmjopen-2025-101684.

  PMID: 41033754 DERIVED

MeSH Terms

Conditions

Developmental Origins of Health and Disease; Pediatric Obesity

Condition Hierarchy (Ancestors)

Prenatal Exposure Delayed Effects; Prenatal Injuries; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Chan, MBBS, MMed, MRCPCh

CONTACT

6563948430; daniel.chan.w.k@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 13, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication and for up to 5 years thereafter.
• Access Criteria: Requests should be directed to the corresponding author (daniel.chan@duke-nus.edu.sg). Proposals must include a methodologically sound plan, and access will be granted for research aligned with the aims outlined in the approved proposal.

Locations

SG (1)