Home » Trials » SLCTR/2021/018

Effectiveness of early lifestyle modification intervention to prevent rapid weight gain in infancy


SLCTR Registration Number


Date of Registration

10 Jul 2021

The date of last modification

Aug 31, 2023

Application Summary

Scientific Title of Trial

Effectiveness of early lifestyle modification intervention to prevent rapid weight gain in infancy

Public Title of Trial

Effectiveness of infant diet and physical activity modifications to prevent rapid weight gain in infants followed up at Teaching Hospital Peradeniya; A Randomized Control Trial

Disease or Health Condition(s) Studied

Childhood obesity

Scientific Acronym


Public Acronym


Brief title

Early life diet and physical activity modification in preventing rapid weight gain in infancy

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority


Trial Details

What is the research question being addressed?

Are life style modifications which include dietary, physical and behavioural changes effective in preventing rapid weight gain during infancy?.

Type of study


Study design


Randomized controlled trial


Single blinded : Participants


Standard therapy/practice





Study Phase

Not Applicable

Intervention(s) planned

Study setting: The intervention will be delivered by the PI on individual basis. The intervention comprises of 5 sessions commencing at the postnatal ward Teaching Hospital Peradeniya followed by 2,4,6 and 9 months based on the proposed framework of early lifestyle modification intervention. Follow up sessions will be held in the Paediatric clinic at Teaching hospital, Peradeniya. Additional monthly telephone calls will be made to ensure retention.

Method of randomization: Envelope method will be used for the small and large for gestational age babies (sample size 24 and 20 respectively). Appropriate number of sealed envelopes with folded opaque paper with the letter “A” for intervention group and letter “B” for control group will be used to assign the selected population to either the intervention or the control groups. The medical officer assigning will randomly select one of the envelops and the subject will be assigned accordingly. The appropriate for gestational age babies will be assigned using Block Randomization. Each block will have 2 assigned to the intervention group and 2 to the control group randomly. 24 such blocks will be decided upon in advance and the recruits will be assigned to each group.

During the first session, the parental guide on Infant and Young; Child Feeding (IYCF) (available in Sinhala, English & Tamil) will be given to all mothers and advice on exclusive breast feeding will be given along with knowledge on hunger cues and satiety cues of the infant which will help establish responsive feeding.

Intervention group: This group will be assessed individually with regard to weight gain trajectory, infant-mother reciprocal response to non-verbal communication indicating hunger and satiety and compliance with age-appropriate physical activity for the infant. The advises and recommendations provided will be more intense and under close monitoring.

Control group: The control group will receive IYCF advises at different local Child Welfare Clinic (CWCs) by different instructors according to the guides that have been provided to them by the Family Health Bureau (FHB). Infants will be followed up at their respective well-baby clinics at 2,4,6,9 and 12 months at Teaching Hospital, Peradeniya. The infants will undergo the same assessment as the intervention group.

The difference would be the more meticulous and intense individual management under careful monitoring offered to the intervention group by a single pediatrician.

Inclusion criteria

Live newborns of singleton term pregnant mothers attending teaching hospital, Peradeniya

Exclusion criteria

(1) pre term(<37 weeks of POA) and post term(>42 weeks of POA) deliveries (2) new born babies with congenital anomalies (3) new born babies requiring intensive care management (4) Infants who develop long term medical or surgical conditions that affect standard feeding practice

Primary outcome(s)


Infant weight gain z score < +0.67 The infant weight gain z score will be calculated considering weight measurements taken between the birth weight and the weight at one year of age.


Final measurement will be taken at 1 year of age


Secondary outcome(s)


Number and percentage of infants who achievement of normal weight for length (-1SD to +1SD).


Final measurement will be taken at 1 year of age


Number and percentage of infants who have anthropometric parameters (Weight for age, Length for age, Abdominal circumference and skin fold thickness (SFT) (biceps, triceps, subscapular and suprailiac)) within normal range according to the WHO recommendation at the age of 1 year


Final measurement will be taken at 1 year of age


Target number/sample size

768 (384 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment


Date of study completion

Recruitment status

Complete: follow up continuing

Funding source

Not funded

Regulatory approvals

State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Peradeniya.
Institutional Address:Faculty of Medicine, University of Peradeniya.

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr.Vasana Kiridana
Consultant Paediatrician / Senior Lecturer
Faculty of Medicine, University of Peradeniya.



Contact Person for Public Queries

Dr.Vasana Kiridana
Consultant Paediatrician / Senior Lecturer
Faculty of Medicine, University of Peradeniya.



Primary study sponsor/organization

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results