Effectiveness of a Positive Deviance Program in Reducing Childhood Undernutrition (NCT04688515) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of a Positive Deviance Program in Reducing Childhood Undernutrition
Malaysia74 participantsStarted 2022-03-09
Plain-language 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.
Who can participate
Age range
3 Years – 5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in body weight after 3 months of intervention in children
Timeframe: 3 months
2
Changes in weight-for-age z score after 3 months of intervention in children
Timeframe: 3 months
3
Changes in height-for-age z score after 3 months of intervention in children
Timeframe: 3 months
4
Changes in weight-for-height z score after 3 months of intervention in children
Timeframe: 3 months
5
Changes in dietary intake after 3 months of intervention in children
Timeframe: 3 months
6
Changes in diet quality after 3 months of intervention in children