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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorKK Women's and Children's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women

34-36 weeks' pregnant, or 3 days post-delivery.

Pre-pregnancy BMI of at least 23 kg/m², and/or with the diagnosis of gestational diabetes mellitus or type 2 diabetes mellitus.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Intervention Arm (Exposed to FLAGs Digital Health Application)Experimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Longitudinal growth trajectories and markers of infant metabolic health

Weight (kilograms)

Time frame
12 months from recruitment
2

Longitudinal growth trajectories and markers of infant metabolic health

Length (meters)

Time frame
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).

Time frame
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

Time frame
12 months from recruitment

Secondary outcomes

1

Indicators of good feeding and lifestyle behaviour

Feeding Lifestyle Activity Goals score, % -higher score denotes better feeding and lifestyle behaviour

Time frame
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

Time frame
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

Time frame
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

Time frame
12 months from recruitment

Other outcomes

Sponsors and contacts

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