Malnutrition, ChildNCT04688515
Effectiveness of a Positive Deviance Program in Reducing Childhood Undernutrition
A study testing Nutrition program developed using positive deviance approach in people with Malnutrition, Child, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Nutrition program developed using positive deviance approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteMalaysia
- Study dates
- 9 Mar 2022to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Malaysian
- Children aged 3 to 5 years old
- Mothers aged above 18 years old
- Living in public low-cost PPR flat
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Background:
Undernourished children who fail to grow in height and weight as other normal children can be underweight, stunting or wasting. In fully urbanized area such as Kuala Lumpur in Malaysia, the consequences of undernutrition are more detrimental in urban poor young children. Since young children are generally depending on maternal feeding for daily diet, alternative intervention that focus on encouraging positive change in maternal behaviour when feeding children might be efficient in reducing childhood undernutrition. The positive deviance (PD) approach is one such alternative intervention. This approach emphases the identification of positive deviant, individuals who successfully discover a way to solve a problem by performing some uncommon but advantageous actions or behaviours in the same underprivileged environment as their peers. In the context of child nutrition, positive deviance is more frequently referred to as adaptive child care practices, positive hygiene practices and feeding practices that enable children to develop appropriately in a harsh environment with limited resources. The nutrition program developed using this approach helps to discover positive deviant, spread local wisdom from mothers of well-nourished children to mothers of undernourished children, and initiate positive behavioural change as a preliminary step to promote healthy weight gain in children.
Methods:
This is a mixed method study which will be carried out in two phases. Phase I of the study will involve focus group discussion (FGD) with semi-structured interview to explore maternal feeding practices and also foods being fed to children. Mothers of children aged 3 to 5 years old will be recruited through purposive sampling or until saturation point is reached. Phase II of the study will involve a two-armed randomized controlled trial to evaluate effectiveness of nutrition program. A total of 164 mother-child dyads will be recruited, in which 82 of them will be recruited separately and randomly from different PPR flats with 1:1 allocation to form intervention and comparison groups. Ethical approval will be obtained from the Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia (JKEUPM). Permission to conduct this study in PPR flats and the list of PPR flats in KL will be obtained from the Kuala Lumpur City Hall. Intervention group will need to participate in a nutrition program for 3 months that consists of education session with peer-led cooking session and rehabilitation session. The comparison group will be given all the materials used in the program for reference after the last data collection. The height and weight of children will be measured by researcher. Mothers will be interviewed on the dietary intake of their children. Mothers will also need to answer a Malay language self-administered questionnaire to obtain information on socio-demographic characteristics, nutrition knowledge and food security status. These measurements will be taken at the baseline (before intervention), immediate post-intervention and 3-month post-intervention for both intervention and comparison groups.
- Conditions
- Malnutrition, Child
- Being tested
- Nutrition program developed using positive deviance approach
- Keywords
- Child undernutrition, Positive deviance, Urban poor children, Stunting, Wasting, Weight gain
- Medical subject headings
- Child Nutrition Disorders, Growth Disorders, Cachexia, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition program developed using positive deviance approachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight after 3 months of intervention in children
body weight in kg
Measured: 3 months
Changes in weight-for-age z score after 3 months of intervention in children
weight-for-age z score in standard deviation
Measured: 3 months
Changes in height-for-age z score after 3 months of intervention in children
height-for-age z score in standard deviation
Measured: 3 months
Changes in weight-for-height z score after 3 months of intervention in children
weight-for-height z score in standard deviation
Measured: 3 months
Changes in dietary intake after 3 months of intervention in children
24-hour diet recall (3 days) in kcal
Measured: 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
Measured: 3 months
Secondary outcomes (2)
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start9 Mar 2022
- Primary completion31 Jul 2023
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gan Wan Ying, Universiti Putra Malaysia
- Investigators
- Wan Ying Gan, PhD, Principal investigator, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688515
- Sponsor's protocol ID
- JKEUPM-2020-349
- Status last verified
- May 2024
- First submitted
- 20 Dec 2020
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17603960Sternin, 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.
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.
PubMed 36227928
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04688515
- Acronym / sponsor ID
- JKEUPM-2020-349
- Conditions
- Malnutrition, Child
- Keywords
- Child undernutrition, Positive deviance, Urban poor children, Stunting, Wasting, Weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Undernourished children who fail to grow in height and weight as other normal children can be underweight, stunting or wasting. In fully urbanized area such as Kuala Lumpur in Malaysia, the consequences of undernutrition are more detrimental in urban poor young children. Since young children are generally depending on maternal feeding for daily diet, alternative intervention that focus on encouraging positive change in maternal behaviour when feeding children might be efficient in reducing childhood undernutrition. The positive deviance (PD) approach is one such alternative intervention. This approach emphases the identification of positive deviant, individuals who successfully discover a way to solve a problem by performing some uncommon but advantageous actions or behaviours in the same underprivileged environment as their peers. In the context of child nutrition, positive deviance is more frequently referred to as adaptive child care practices, positive hygiene practices and feeding practices that enable children to develop appropriately in a harsh environment with limited resources. The nutrition program developed using this approach helps to discover positive deviant, spread local wisdom from mothers of well-nourished children to mothers of undernourished children, and initiate positive behavioural change as a preliminary step to promote healthy weight gain in children.
Methods:
This is a mixed method study which will be carried out in two phases. Phase I of the study will involve focus group discussion (FGD) with semi-structured interview to explore maternal feeding practices and also foods being fed to children. Mothers of children aged 3 to 5 years old will be recruited through purposive sampling or until saturation point is reached. Phase II of the study will involve a two-armed randomized controlled trial to evaluate effectiveness of nutrition program. A total of 164 mother-child dyads will be recruited, in which 82 of them will be recruited separately and randomly from different PPR flats with 1:1 allocation to form intervention and comparison groups. Ethical approval will be obtained from the Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia (JKEUPM). Permission to conduct this study in PPR flats and the list of PPR flats in KL will be obtained from the Kuala Lumpur City Hall. Intervention group will need to participate in a nutrition program for 3 months that consists of education session with peer-led cooking session and rehabilitation session. The comparison group will be given all the materials used in the program for reference after the last data collection. The height and weight of children will be measured by researcher. Mothers will be interviewed on the dietary intake of their children. Mothers will also need to answer a Malay language self-administered questionnaire to obtain information on socio-demographic characteristics, nutrition knowledge and food security status. These measurements will be taken at the baseline (before intervention), immediate post-intervention and 3-month post-intervention for both intervention and comparison groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Nutrition program developed using positive deviance approachIntervention group refers to mother-child dyads who will be participating in a nutrition program consisting of nutrition education and cooking sessions for 3 months. |
| 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Malaysian
- Children aged 3 to 5 years old
- Mothers aged above 18 years old
- Living in public low-cost PPR flat
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition program developed using positive deviance approachIt 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. | Behavioural | Intervention group |
Primary outcome
Changes in body weight after 3 months of intervention in children
Time frame: 3 months
body weight in kg
Changes in weight-for-age z score after 3 months of intervention in children
Time frame: 3 months
weight-for-age z score in standard deviation
Changes in height-for-age z score after 3 months of intervention in children
Time frame: 3 months
height-for-age z score in standard deviation
Changes in weight-for-height z score after 3 months of intervention in children
Time frame: 3 months
weight-for-height z score in standard deviation
Changes in dietary intake after 3 months of intervention in children
Time frame: 3 months
24-hour diet recall (3 days) in kcal
Changes in diet quality after 3 months of intervention in children
Time frame: 3 months
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
2 secondary outcomes
Changes in nutrition knowledge after 3 months of intervention in mothers
Time frame: 3 months
Assessment of food security level after 3 months of intervention in mothers
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- BackgroundAlbanna, 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
- BackgroundHerington, 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: PubMed 17603960Schooley 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.
- BackgroundSternin, 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.
- BackgroundThe CORE group. (2002). Positive deviance / Hearth essential elements: A resource guide for sustainably rehabilitating malnourished children. CORE group.
- Derived from this study: PubMed 36227928Chek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Ying Gan, PhD principal investigator
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition program developed using positive deviance approach in people with Malnutrition, Child, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight after 3 months of intervention in children (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04688515, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.