NCT04688515

Brief Summary

Globally, childhood malnutrition remains a public health concern. Malnutrition can be diverse from undernutrition to overnutrition. A young child, primarily refers to those under the age of 5, is suffering from undernutrition when the child is lacking of adequate nutrition that necessary for proper growth and health due to direct or indirect causes such as not having enough food. In fully urbanized area such as Kuala Lumpur, urban poor children tend to face greater deprivations such as lower education and poor health which significantly influence their daily diet and nutritional status. Hence, urban poor children who are living and growing up in such underprivileged environment should not be neglected. Since young children are generally depending on maternal feeding for daily diet, intervention that focus on encouraging positive change in maternal feeding practices might be efficient in reducing childhood undernutrition. The positive deviance (PD) approach may consider as a better alternative to empower mothers by promoting new behaviour to feed their children. Hence, this study aims to evaluate the effectiveness of a nutrition program using PD approach in reducing undernutrition among urban poor children aged 3 to 5 years old in Kuala Lumpur.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 30, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 9, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

December 20, 2020

Last Update Submit

May 6, 2024

Conditions

Keywords

Child undernutritionPositive devianceUrban poor childrenStuntingWastingWeight gain

Outcome Measures

Primary Outcomes (6)

  • Changes in body weight after 3 months of intervention in children

    body weight in kg

    3 months

  • Changes in weight-for-age z score after 3 months of intervention in children

    weight-for-age z score in standard deviation

    3 months

  • Changes in height-for-age z score after 3 months of intervention in children

    height-for-age z score in standard deviation

    3 months

  • Changes in weight-for-height z score after 3 months of intervention in children

    weight-for-height z score in standard deviation

    3 months

  • Changes in dietary intake after 3 months of intervention in children

    24-hour diet recall (3 days) in kcal

    3 months

  • Changes in diet quality after 3 months of intervention in children

    Healthy Eating Index (HEI) for Malaysians; composite HEI scores range from 0 to 100%; score \<51% indicates poor diet quality, 51 to 80% indicates diet required improvement, and \>80% indicates good diet quality

    3 months

Secondary Outcomes (2)

  • Changes in nutrition knowledge after 3 months of intervention in mothers

    3 months

  • Assessment of food security level after 3 months of intervention in mothers

    3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group refers to mother-child dyads who will be participating in a nutrition program consisting of nutrition education and cooking sessions for 3 months.

Behavioral: Nutrition program developed using positive deviance approach

Comparison group

NO INTERVENTION

The comparison group will not receive any intervention but will be provided with the developed educational materials used in the program after the program has been completed.

Interventions

It is a 3-month nutrition program including nutrition education session and rehabilitation session. The education session consists of half hour education lesson and one and half hours peer-led cooking session. The cooking demonstration will be led by volunteers from PD family. Participating mothers will need to bring along their children during this session, prepare meal according to pre-planned menu and feed their children with the prepared meal after cooking as snack or additional meal. The rehabilitation session will be the rest of the days following each education session until the next education session. Growth monitoring session will also be conducted in each session, whereby mothers will be taught and trained to weigh their children.

Intervention group

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Malaysian
  • Children aged 3 to 5 years old
  • Mothers aged above 18 years old
  • Living in public low-cost PPR flat

You may not qualify if:

  • Children who are taken care by other adults rather than mothers such as father, grandparents and caregivers
  • Mothers with mental disabilities
  • Children with history of chronic diseases including congenital heart disease, liver disease, renal failure or sickle cell disease and any congenital abnormalities
  • Children who are under treatment for communicable disease such as measles and chickenpox
  • Children with learning disabilities
  • Mother-child dyads involved in any other intervention or clinical research
  • Children who are overweight or obese

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPR

Kuala Lumpur, Malaysia

Location

Related Publications (6)

  • Albanna, B., & Heeks, R. (2019). Positive deviance, big data, and development: A systematic literature review. Electronic Journal of Information Systems in Developing Countries, 85(1), e12063. https://doi.org/10.1002/isd2.12063

    BACKGROUND
  • Herington, M. J., & Fliert, E. Van De. (2017). Positive deviance in theory and practice : A conceptual review. Deviant Behavior, 39(5), 664-678. https://doi.org/10.1080/01639625.2017.1286194

    BACKGROUND
  • Schooley J, Morales L. Learning from the community to improve maternal-child health and nutrition: the Positive Deviance/Hearth approach. J Midwifery Womens Health. 2007 Jul-Aug;52(4):376-83. doi: 10.1016/j.jmwh.2007.03.001.

    PMID: 17603960BACKGROUND
  • Sternin, M., Sternin, J., & Marsh, D. (1998). Designing a community-based nutrition program using the hearth model and the positive deviance approach - A field guide. Save the Children Federation.

    BACKGROUND
  • The CORE group. (2002). Positive deviance / Hearth essential elements: A resource guide for sustainably rehabilitating malnourished children. CORE group.

    BACKGROUND
  • Chek LP, Gan WY, Chin YS, Sulaiman N. A nutrition programme using positive deviance approach to reduce undernutrition among urban poor children under-five in Malaysia: A cluster randomised controlled trial protocol. PLoS One. 2022 Oct 13;17(10):e0275357. doi: 10.1371/journal.pone.0275357. eCollection 2022.

MeSH Terms

Conditions

Child Nutrition DisordersGrowth DisordersCachexiaWeight Gain

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinness

Study Officials

  • Wan Ying Gan, PhD

    Universiti Putra Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2020

First Posted

December 30, 2020

Study Start

March 9, 2022

Primary Completion

July 31, 2023

Study Completion

March 10, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations