AzTrials
AzTrials

Childhood Obesity PreventionNCT06457750

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

A study testing Feeding, Lifestyle, Activity Goals (FLAGs) Digital Health Application in people with Childhood Obesity Prevention, run by KK Women's and Children's Hospital at 1 site in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Childhood Obesity Prevention
What is being tested?
Feeding, Lifestyle, Activity Goals (FLAGs) Digital Health Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
1 siteSingapore
Study dates
1 Nov 2025to 30 Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Women
  • 34-36 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel Chan, MBBS, MMed, MRCPCh contact

6563948430

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

Singapore1 site
  • KK Women's and Children's Hospital

    Singapore, Singapore, 229899

    Daniel Chan, MBBS, MMed, MRCPCh, 6563948430, daniel.chan.w.k@singhealth.com.sg

Other trials in Singapore

About this study

Official title: Anthropometric and Body Composition Outcomes of a Mobile Health Intervention to Improve Eating Behaviours and Lifestyle Habits During Infancy

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.

Read the detailed description

Childhood obesity rates have been steadily increasing worldwide, reaching 5.6% for girls and 7.8% for boys in 2016, compared to 0.7% and 0.9% in 1975, respectively. The rise has led to the development of multiple metabolic co-morbidities among children, including dysglycaemia, hypertension, hyperlipidaemia, and fatty liver disease. Childhood obesity also sets the stage for adult overweight and obesity, along with increased cardiovascular risks. Therefore, it is essential to start right early with healthy lifestyle and feeding practices since birth. Implementing interventions during the postpartum period holds the potential for long-term maternal-child benefits, fostering a virtuous cycle of health. Cardiometabolic risk factors have been clearly identified from early childhood, such as the consumption of sugar-sweetened beverages, suboptimal weaning practices with inadequate introduction of diverse food consistencies and tastes within the first six months of life, excessive or inadequate caloric intake, and excessive screen time exposure. These factors are associated with increased body mass index in children. Given the social and environmental nature of these influences, effective approaches are those which intervene holistically through community engagement to modify behaviour, adopting the use of digital and technology-based healthcare.

Existing infant care models undervalue the importance of establishing healthy lifestyle behaviours and optimal eating outcomes for infants and toddlers. Furthermore, there is a gap between what is known to increase a child's risks of developing non-communicable diseases as an adult, and what caregivers understand about optimizing their child's health. Addressing this unmet need requires innovative and sustainable intervention approach to apply for the general public. Digital technologies possess immense potential for advancing health promotion and public health initiatives, maximizing community outreach and engagement. The investigators have developed an innovative digitalized tool, called Feeding, Lifestyle, Activity Goals (FLAGs) to assess lifestyle and feeding behaviours of young children from birth to age 2. FLAGs provides performance evaluation, guidance, and tailored advice for parents on ideal practices specific to their children. This digital application can be easily administered right via computers or smart devices from birth. FLAGs has undergone content and expert validations by eight domain experts from primary and tertiary healthcare settings, receiving positive evaluations regarding tool validity through high scores on the scale content validity index and agreement test.

The investigators' goal is to establish healthy lifestyle behaviours in infants, leading to improved health outcomes in early years. The overall objective of this proposed study is to determine the effects of FLAGs intervention on infant's lifestyle behaviours, growth, and metabolic health outcomes. The central hypothesis is that infants whose caregivers are exposed to FLAGs intervention will exhibit healthier lifestyle behaviours, leading to optimal physical growth and metabolic health status at 12 months of age, compared to those without FLAGs intervention. To test the hypothesis, a prospective, two-arm, randomized controlled trial will be conducted, recruiting 440 infant-caregiver pairs with a 1-year follow-up from KK Women's and Children's Hospital. Participants in the intervention arm will be exposed to FLAGs over a 1-year period. The specific aims are as follows:

Aim 1: To determine usability, acceptability, and feasibility of the FLAGs digital tool by conducting a pilot phase study. From results of this pilot phase study, further refinement to the application's content, user interface, and features will be performed before proceeding on to determine its efficacy.

Aim 2: To examine the effect of FLAGs intervention on infant body mass index, weight for length, and body composition at 12 months of age. The investigators hypothesize that after 12 months of FLAGs intervention, infants will demonstrate lower body mass index, weight for length, and reduced body fat as measured by skinfold thickness and body fat percentage at 12 months of age.

Aim 3: To examine the effect of FLAGs intervention on infant's lifestyle and eating behaviours at 12 months of age. The investigators hypothesize that infants randomised to the FLAGs intervention arm will demonstrate significantly healthier lifestyle behaviour, as indicated by a higher total FLAGs score, along with healthier eating habits, compared to those randomised to the control arm without FLAGs intervention. The total FLAGs score will be derived from the summation scores of the infant eating, sleeping, and activity domains in the FLAGs tool. Eating habits will be measured using established and validated questionnaires.

This proposed study will demonstrate the benefits of using FLAGs, a digital assessment and advisory tool to shape an infant's behaviour and early health outcomes, thereby highlighting its importance to be integrated into current models of paediatric healthcare.

Being tested
Feeding, Lifestyle, Activity Goals (FLAGs) Digital Health Application
Keywords
Developmental origins of health and disease, childhood obesity, life course approach, population health, paediatrics
Medical subject headings
Developmental Origins of Health and Disease, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Feeding, Lifestyle, Activity Goals (FLAGs) Digital Health ApplicationBehavioural

    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.

Study groups in NCT06457750
Study groupRoleWhat they receive
Intervention Arm (Exposed to FLAGs Digital Health Application)ExperimentalParticipants 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.
Receives: Behavioral: Feeding, Lifestyle, Activity Goals (FLAGs) Digital Health Application
Control ArmNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Longitudinal growth trajectories and markers of infant metabolic health

    Weight (kilograms)

    Measured: 12 months from recruitment

  2. Longitudinal growth trajectories and markers of infant metabolic health

    Length (meters)

    Measured: 12 months from recruitment

  3. 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).

    Measured: 12 months from recruitment

  4. Longitudinal growth trajectories and markers of infant metabolic health

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

    Measured: 12 months from recruitment

  5. Longitudinal growth trajectories and markers of infant metabolic health

    Body composition, using skinfold thickness measurements (centimeters)

    Measured: 12 months from recruitment

Secondary outcomes (4)
  1. Indicators of good feeding and lifestyle behaviour

    Feeding Lifestyle Activity Goals score, %

    -higher score denotes better feeding and lifestyle behaviour

    Measured: 12 months from recruitment

  2. Indicators of good feeding and lifestyle behaviour

    Baby Eating Behaviour Questionnaire

    • this is a psychometric measure of infant appetite and eating behavior
    • no scoring system available, findings are not reported on a scale

    Measured: 12 months from recruitment

  3. Indicators of good feeding and lifestyle behaviour

    Children Eating Behaviour Questionnaire

    • psychometric measure of a child's appetite and eating behavior
    • no scoring system available, findings are not reported on a scale

    Measured: 12 months from recruitment

  4. Indicators of good feeding and lifestyle behaviour

    Picky Eating Questionnaire

    • psychometric measure of dietary diversity
    • no scoring system available, findings are not reported on a scale

    Measured: 12 months from recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457750
Sponsor's protocol ID
AM/TP081/2024 (SRDUKAMR2481)
Status last verified
Aug 2025
First submitted
30 May 2024
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data (IPD) underlying the published results will be made available on reasonable request from the corresponding author. Supporting documents, including the study protocol and statistical analysis plan, will also be shared.

Publications

  • 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.

    PubMed 29029897
  • 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.

    PubMed 18331423
  • 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.

    PubMed 32478460
  • 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.

    PubMed 35156934
  • 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.

    PubMed 27864799
  • 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.

    PubMed 41033754

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in