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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
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.
- Conditions
- Childhood Obesity Prevention
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal growth trajectories and markers of infant metabolic health
Weight (kilograms)
Measured: 12 months from recruitment
Longitudinal growth trajectories and markers of infant metabolic health
Length (meters)
Measured: 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).
Measured: 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
Measured: 12 months from recruitment
Longitudinal growth trajectories and markers of infant metabolic health
Body composition, using skinfold thickness measurements (centimeters)
Measured: 12 months from recruitment
Secondary outcomes (4)
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
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
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
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.
- First posted13 Jun 2024
- Study start1 Nov 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Childhood Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Daniel Chan, KK Women's and Children's Hospital
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 29029897Singh 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 18331423Scott 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 32478460Kouvari 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 35156934Tanrikulu 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 27864799Chan 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