Home » Trials » SLCTR/2021/018


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

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SLCTR Registration Number

SLCTR/2021/018


Date of Registration

10 Jul 2021

The date of last modification

Jul 11, 2021



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

None


Public Acronym

None


Brief title

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


Universal Trial Number

U1111-1267-3394


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

2020/EC/49


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Participants


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Prevention


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)

1.

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)

1.

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

]
2.

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

2021-07-11


Anticipated end date

2022-07-11


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Not funded


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2021-03-18


Approval number

2020/EC/49


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.
Telephone:081-2396201
Email:

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

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

0772277421

vkiridana@yahoo.co.uk

Contact Person for Public Queries

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

0772277421

vkiridana@yahoo.co.uk


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)?

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results