Malnutrition, Child Clinical Trial
Official title:
Effectiveness of a Nutrition Program Using Positive Deviance Approach to Reduce Undernutrition Among Urban Poor Children Under Five in Kuala Lumpur, Malaysia: A Two-armed Cluster Randomized Controlled Trial
Verified date | May 2024 |
Source | Universiti Putra Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | March 10, 2024 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 5 Years |
Eligibility | For Phase 1: Inclusion Criteria: - Malaysian - Children aged 3 to 5 years old - Mothers aged above 18 years old - Living in public low-cost PPR flat Exclusion Criteria: - 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 The respondents' selection criteria in Phase 2 are almost similar as in Phase 1 except for the second inclusion criterion that is related to children. In Phase 2, only undernourished children (either underweight, stunting or wasting) aged 3 to 5 years old will be recruited in order to evaluate the effectiveness of the intervention in this particular group. The exclusion criteria in Phase 2 are similar to the exclusion criteria in Phase 1. |
Country | Name | City | State |
---|---|---|---|
Malaysia | PPR | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
Universiti Putra Malaysia |
Malaysia,
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
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
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. — View Citation
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.
The CORE group. (2002). Positive deviance / Hearth essential elements: A resource guide for sustainably rehabilitating malnourished children. CORE group.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in body weight after 3 months of intervention in children | body weight in kg | 3 months | |
Primary | Changes in weight-for-age z score after 3 months of intervention in children | weight-for-age z score in standard deviation | 3 months | |
Primary | Changes in height-for-age z score after 3 months of intervention in children | height-for-age z score in standard deviation | 3 months | |
Primary | Changes in weight-for-height z score after 3 months of intervention in children | weight-for-height z score in standard deviation | 3 months | |
Primary | Changes in dietary intake after 3 months of intervention in children | 24-hour diet recall (3 days) in kcal | 3 months | |
Primary | 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 | Changes in nutrition knowledge after 3 months of intervention in mothers | 20-item nutrition knowledge questionnaire; total scores range from 0 to 20 marks; higher score indicates good knowledge | 3 months | |
Secondary | Assessment of food security level after 3 months of intervention in mothers | 6-item USDA Short Form Food Security Survey Module; It consists of affirmative responses such as 'always', 'sometimes', and 'yes', as well as non-affirmative responses such as 'never', 'no', and 'don't know'. An affirmative response is given a score of 1 and a non-affirmative response is given a 0 score. The possible total scores range from 0 to 6, and a score of 2 or higher indicates food insecurity | 3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05012592 -
Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses
|
N/A | |
Completed |
NCT04216043 -
Milk Matters in Malnutrition, is it the Lactose or Dairy Protein?
|
N/A | |
Enrolling by invitation |
NCT05603793 -
YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
|
||
Completed |
NCT03573713 -
Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes
|
N/A | |
Not yet recruiting |
NCT05792514 -
The Reliable Nutritional Risk Screening Tools
|
||
Recruiting |
NCT04109352 -
Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy
|
||
Enrolling by invitation |
NCT03355313 -
Use of Low-level Laser Therapy on Children Aged One to Five Years With Energy-protein Malnutrition
|
N/A | |
Completed |
NCT05551819 -
Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition
|
N/A | |
Completed |
NCT04101487 -
Cash Transfers to Increase Dietary Diversity in Grand Gedeh County, Liberia
|
N/A | |
Active, not recruiting |
NCT05571280 -
Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene.
|
N/A | |
Withdrawn |
NCT05437068 -
Nutritional Supplementation in Children at Risk of Undernutrition
|
N/A | |
Recruiting |
NCT05442424 -
Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii
|
N/A | |
Completed |
NCT03454100 -
Community Resilience to Acute Malnutrition
|
N/A | |
Completed |
NCT04896996 -
The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY)
|
N/A | |
Not yet recruiting |
NCT06049680 -
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
|
Phase 4 | |
Recruiting |
NCT06382857 -
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
|
N/A | |
Recruiting |
NCT05269992 -
Childrens Real Food Tolerance Study
|
N/A | |
Active, not recruiting |
NCT05123378 -
Liberia National Community Health Assistant (NCHA) Program and Under-five Mortality
|
N/A | |
Not yet recruiting |
NCT04810468 -
Study of Malnutrition in Primary School Children
|
N/A | |
Completed |
NCT04334538 -
Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition
|
N/A |