Underweight Children Aged 6-23 Month Old (WAZ < -1)NCT03399058
Innovative Nutrition and mHealth Evidence Building Project
A study testing Group 2: 5+5+5 & PDH and Group 3: 5+5+5 & PDH lite+mHealth in people with Underweight Children Aged 6-23 Month Old (WAZ < -1), run by National Institute of Public Health, Cambodia at 3 sites in Cambodia.
Trial summary
The project is the collaboration with the lead agencies National Institute of Public Health, World Vision and Emory University World Vision has a history of successfully implementing "Positive Deviance/Hearth (PDH)" programs across the globe. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Underweight Children Aged 6-23 Month Old (WAZ < -1)
- What is being tested?
- Group 2: 5+5+5 & PDH and Group 3: 5+5+5 & PDH lite+mHealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 3 sitesCambodia
- Study dates
- 27 Nov 2017to 30 Sep 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child 6-23 months residing in study area and intending to stay in area for study duration
- Underweight child (Weight for Age Z-score < -1)
Who cannot join
- No access to mobile phone
- Severe Acute malnutrition (Weight for Height Z-score <-3), Edema
Trial locations and contacts
3 sites in 1 country.
Cambodia3 sites
ADP Boribor 2
Kampong Chhnang
ADP Rolea Phaea
Kampong Chhnang
ADP Samrong Tong 2
Kampong Speu, Kamong Speu
About this study
Official title: A Randomized Cluster Controlled Study of an Interactive Voice Response Intervention and PD/Hearth ("PDH") to Improve Knowledge, Behavior Change, and Level of Confidence in Caregivers of Underweight Children in Cambodia
The project is the collaboration with the lead agencies National Institute of Public Health, World Vision and Emory University World Vision has a history of successfully implementing "Positive Deviance/Hearth (PDH)" programs across the globe. PDH is a community-based intervention utilizing locally appropriate health and infant feeding practices to rehabilitate underweight children and promote behavioral changes in caregivers. A recent systematic review on the PD/Hearth approach found that although some programs show clear success in particular settings, overall, the results were mixed for program effectiveness.
Furthermore, with the growing use of mobile phones and technology in the world, including Cambodia, there have been various studies and a systematic review that found SMS reminders and voice recordings to have promising impact on behavior change of patients for smoking cessation and improved adherence to drugs for asthma patients. Although there are positive findings around the use of mobile devices to improve behavior change, there has yet to be a study that examines the impact of mobile phones on improving behavior change of caregivers related to nutrition, water, sanitation and hygiene (WASH), health, and caring practices, which as a result, would decrease the prevalence of underweight in children 6-23 months of age.
Read more
This study will provide evidence on the effectiveness of the PDH model in Cambodia compared to the current standard of care. Investigators believe the PDH approach will be a powerful tool to reduce child malnutrition. In addition, given the intensity and cost burden associated with PDH, investigators will simultaneously test if the intensity of the PDH model can be reduced by introducing an innovative application of mHealth to replace 50% of face-to-face education sessions (5 days) and all follow up visits with mobile support calls. Collectively this research will provide critical data to inform program operations on the optimal and most effective method to reduce child underweight in Cambodia.
In Year 1, the purpose of this study is to assess the effectiveness of contextualized messages through PDH programs and a mobile technology (mHealth), to improve knowledge, behaviour change, and level of confidence of caregivers with underweight children aged 6-23 months in feeding, hygiene, health-seeking, and caring practices. In Year 2, the study's aim will be to assess the prevention of underweight in the siblings of the children included in the three programs outside of the 360 study subjects from Year 1.
- Being tested
- Group 1 5+5+5 (Control), Group 2: 5+5+5 & PDH, Group 3: 5+5+5 & PDH lite+mHealth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 5+5+5 (Control)Other
The standard of care in Cambodia is known as the basic health and nutrition service package or 5+5+5. The participants in the first group will be the control group and will only be implementing the standard of care, 5+5+5 package (Group 1).
Group 2: 5+5+5 & PDHBehavioural
The participants in the second group will receive contextualized Hearth messages through on-going PDH programs in addition to the basic standard of care (Group 2).
Group 3: 5+5+5 & PDH lite+mHealthBehavioural
The participants in the third group will receive a PDH lite program and receive follow-up through mobile support phone calls (Group 3).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 5+5+5 (Control) | Other | The standard of care in Cambodia is known as the basic health and nutrition service package or 5+5+5. The participants in the first group will be the control group and will only be implementing the standard of care, 5+5+5 package (Group 1). Receives: Other: Group 1 5+5+5 (Control) |
| Group 2: 5+5+5 & PDH | Other | The participants in the second group will receive contextualized Hearth messages through on-going PDH programs in addition to the basic standard of care (Group 2). The Hearth messages are contextualized messages on child feeding practices that women in the community have found helpful to successfully prevent child malnutrition. This program will be delivered through in person community meetings. Receives: Behavioral: Group 2: 5+5+5 & PDH |
| Group 3: 5+5+5 & PDH lite+mHealth | Other | The participants in the third group will receive a similar program as group 2 with contextualized child feeding messages (PDH lite program) and receive follow-up through mobile support phone calls (Group 3). Receives: Behavioral: Group 3: 5+5+5 & PDH lite+mHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prevalence of underweight children over time
Weight, height/length and MUAC will be measured at Baseline (Month 0), Month 3, and Month 12. The data such as weight, height/length, MUAC, gender, and date of birth are needed to calculate the prevalence of underweight children. These data will be entered into the software ENA2015 to compare the weight-for-age, MUAC, height-for-age, and weight-for-height data to the international WHO reference standards in order to identify the underweight status of the children. The investigators will assess the difference in prevalence of underweight children among the three arms between baseline (Month 0), midline (month 3), and endline (month 12).
Measured: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Change in mean of weight (grams) over time
Weight, height/length and MUAC will be measured at Baseline (month 0), Month 3, and Month 12. The investigators will assess the change in mean of weight (grams) among the three arms between baseline (Month 0), midline (month 3), and endline (month 12).
Measured: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Change in percentage of caregivers correctly answering questions on child feeding, hygiene, health-seeking and caring practices over time
The investigators will assess the knowledge improvement regarding the child feeding, hygiene, health-seeking and caring practices between Baseline (Month 0), Midline (Month 3), Endline (Month 12) through quantitative questionnaire. The questionnaire was established by the research team which consists of topic around child feeding, hygiene, caring, health-seeking practices.
Measured: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Change in percentage of caregivers who have adopted proper child feeding, hygiene, health-seeking, and caring practices
The investigators will assess the behavioral change regarding the child feeding, hygiene, health-seeking and caring practices between Baseline (Month 0), Midline (Month 3), Endline (Month 12) through quantitative questionnaire. The questionnaire was established by the research team which consists of topic around child feeding, hygiene, caring, health-seeking practices.
Measured: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Change in percentage of caregivers self-reporting confidence in ability to adopt proper child feeding, hygiene, health-seeking, and caring practices over time
The investigators will assess the confident level in ability to adopt proper child feeding, hygiene, health-seeking, and caring practics between Baseline (Month 0), Midline (Month 3), Endline (Month 12) through quantitative questionnaire. The questionnaire was established by the research team which consists of topic around child feeding, hygiene, caring, health-seeking practices.
Measured: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Assess the percentage of siblings of enrolled children in each group with a weight for height z-score <-2
Assessment of the percentage of underweight younger siblings of the child who was admitted into the program will be assessed through rapid survey. Younger siblings of the enrolled children will be measured weight, height/length and MUAC at the Year 2 endline. The data such as weight, height/length, MUAC, gender, and date of birth are needed to calculate the prevalence of underweight children. These data will be entered into the software ENA2015 to compare the weight-for-age, MUAC, height-for-age, and weight-for-height data to the international WHO reference standards in order to identify the underweight status of the children. The investigators will assess the difference in prevalence of underweight children among the three arms.
Measured: Measured at Year 2 Endline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start27 Nov 2017
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Underweight Children Aged 6-23 Month Old (WAZ < -1)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 840 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Public Health, Cambodia
- Sponsor type
- Other government
- Collaborators
- World Vision International, World Vision, Hong Kong, World Vision, Cambodia, Emory University
- Responsible party
- Principal investigator, ChheaChhorvann, National Institute of Public Health, Cambodia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399058
- Sponsor's protocol ID
- 156NECHR
- Status last verified
- Mar 2021
- First submitted
- 22 Nov 2017
- Last updated
- 4 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baik D, Reinsma K, Chhorvann C, Oy S, Heang H, Young MF. Program Impact Pathway of the Positive Deviance/Hearth Interactive Voice Calling Program in a Peri-Urban Context of Cambodia. Curr Dev Nutr. 2022 Mar 28;6(5):nzac045. doi: 10.1093/cdn/nzac045. eCollection 2022 May.
PubMed 35611354
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cluster Controlled Study of an Interactive Voice Response Intervention and PD/Hearth ("PDH") to Improve Knowledge, Behavior Change, and Level of Confidence in Caregivers of Underweight Children in Cambodia
- ClinicalTrials.gov ID
- NCT03399058
- Acronym / sponsor ID
- 156NECHR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- National Institute of Public Health, CambodiaOther government
- Collaborators
- World Vision International, World Vision, Hong Kong, World Vision, Cambodia, Emory University
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 16 Jan 2018 (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.
The project is the collaboration with the lead agencies National Institute of Public Health, World Vision and Emory University World Vision has a history of successfully implementing "Positive Deviance/Hearth (PDH)" programs across the globe. PDH is a community-based intervention utilizing locally appropriate health and infant feeding practices to rehabilitate underweight children and promote behavioral changes in caregivers. A recent systematic review on the PD/Hearth approach found that although some programs show clear success in particular settings, overall, the results were mixed for program effectiveness.
Furthermore, with the growing use of mobile phones and technology in the world, including Cambodia, there have been various studies and a systematic review that found SMS reminders and voice recordings to have promising impact on behavior change of patients for smoking cessation and improved adherence to drugs for asthma patients. Although there are positive findings around the use of mobile devices to improve behavior change, there has yet to be a study that examines the impact of mobile phones on improving behavior change of caregivers related to nutrition, water, sanitation and hygiene (WASH), health, and caring practices, which as a result, would decrease the prevalence of underweight in children 6-23 months of age.
This study will provide evidence on the effectiveness of the PDH model in Cambodia compared to the current standard of care. Investigators believe the PDH approach will be a powerful tool to reduce child malnutrition. In addition, given the intensity and cost burden associated with PDH, investigators will simultaneously test if the intensity of the PDH model can be reduced by introducing an innovative application of mHealth to replace 50% of face-to-face education sessions (5 days) and all follow up visits with mobile support calls. Collectively this research will provide critical data to inform program operations on the optimal and most effective method to reduce child underweight in Cambodia.
In Year 1, the purpose of this study is to assess the effectiveness of contextualized messages through PDH programs and a mobile technology (mHealth), to improve knowledge, behaviour change, and level of confidence of caregivers with underweight children aged 6-23 months in feeding, hygiene, health-seeking, and caring practices. In Year 2, the study's aim will be to assess the prevention of underweight in the siblings of the children included in the three programs outside of the 360 study subjects from Year 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 5+5+5 (Control) | Other | Other: Group 1 5+5+5 (Control)The standard of care in Cambodia is known as the basic health and nutrition service package or 5+5+5. The participants in the first group will be the control group and will only be implementing the standard of care, 5+5+5 package (Group 1). |
| Group 2: 5+5+5 & PDH | Other | Behavioral: Group 2: 5+5+5 & PDHThe participants in the second group will receive contextualized Hearth messages through on-going PDH programs in addition to the basic standard of care (Group 2). The Hearth messages are contextualized messages on child feeding practices that women in the community have found helpful to successfully prevent child malnutrition. This program will be delivered through in person community meetings. |
| Group 3: 5+5+5 & PDH lite+mHealth | Other | Behavioral: Group 3: 5+5+5 & PDH lite+mHealthThe participants in the third group will receive a similar program as group 2 with contextualized child feeding messages (PDH lite program) and receive follow-up through mobile support phone calls (Group 3). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Child 6-23 months residing in study area and intending to stay in area for study duration
- Underweight child (Weight for Age Z-score < -1)
Key exclusion criteria (2 listed)
- No access to mobile phone
- Severe Acute malnutrition (Weight for Height Z-score <-3), Edema
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 |
|---|---|---|
| Group 1 5+5+5 (Control)The standard of care in Cambodia is known as the basic health and nutrition service package or 5+5+5. The participants in the first group will be the control group and will only be implementing the standard of care, 5+5+5 package (Group 1). | Other | Group 1 5+5+5 (Control) |
| Group 2: 5+5+5 & PDHThe participants in the second group will receive contextualized Hearth messages through on-going PDH programs in addition to the basic standard of care (Group 2). | Behavioural | Group 2: 5+5+5 & PDH |
| Group 3: 5+5+5 & PDH lite+mHealthThe participants in the third group will receive a PDH lite program and receive follow-up through mobile support phone calls (Group 3). | Behavioural | Group 3: 5+5+5 & PDH lite+mHealth |
Primary outcome
Change in prevalence of underweight children over time
Time frame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Weight, height/length and MUAC will be measured at Baseline (Month 0), Month 3, and Month 12. The data such as weight, height/length, MUAC, gender, and date of birth are needed to calculate the prevalence of underweight children. These data will be entered into the software ENA2015 to compare the weight-for-age, MUAC, height-for-age, and weight-for-height data to the international WHO reference standards in order to identify the underweight status of the children. The investigators will assess the difference in prevalence of underweight children among the three arms between baseline (Month 0), midline (month 3), and endline (month 12).
Change in mean of weight (grams) over time
Time frame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Weight, height/length and MUAC will be measured at Baseline (month 0), Month 3, and Month 12. The investigators will assess the change in mean of weight (grams) among the three arms between baseline (Month 0), midline (month 3), and endline (month 12).
Change in percentage of caregivers correctly answering questions on child feeding, hygiene, health-seeking and caring practices over time
Time frame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
The investigators will assess the knowledge improvement regarding the child feeding, hygiene, health-seeking and caring practices between Baseline (Month 0), Midline (Month 3), Endline (Month 12) through quantitative questionnaire. The questionnaire was established by the research team which consists of topic around child feeding, hygiene, caring, health-seeking practices.
Change in percentage of caregivers who have adopted proper child feeding, hygiene, health-seeking, and caring practices
Time frame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
The investigators will assess the behavioral change regarding the child feeding, hygiene, health-seeking and caring practices between Baseline (Month 0), Midline (Month 3), Endline (Month 12) through quantitative questionnaire. The questionnaire was established by the research team which consists of topic around child feeding, hygiene, caring, health-seeking practices.
Change in percentage of caregivers self-reporting confidence in ability to adopt proper child feeding, hygiene, health-seeking, and caring practices over time
Time frame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
The investigators will assess the confident level in ability to adopt proper child feeding, hygiene, health-seeking, and caring practics between Baseline (Month 0), Midline (Month 3), Endline (Month 12) through quantitative questionnaire. The questionnaire was established by the research team which consists of topic around child feeding, hygiene, caring, health-seeking practices.
Assess the percentage of siblings of enrolled children in each group with a weight for height z-score <-2
Time frame: Measured at Year 2 Endline
Assessment of the percentage of underweight younger siblings of the child who was admitted into the program will be assessed through rapid survey. Younger siblings of the enrolled children will be measured weight, height/length and MUAC at the Year 2 endline. The data such as weight, height/length, MUAC, gender, and date of birth are needed to calculate the prevalence of underweight children. These data will be entered into the software ENA2015 to compare the weight-for-age, MUAC, height-for-age, and weight-for-height data to the international WHO reference standards in order to identify the underweight status of the children. The investigators will assess the difference in prevalence of underweight children among the three arms.
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 4 Mar 2021.
- Derived from this study: PubMed 35611354Baik D, Reinsma K, Chhorvann C, Oy S, Heang H, Young MF. Program Impact Pathway of the Positive Deviance/Hearth Interactive Voice Calling Program in a Peri-Urban Context of Cambodia. Curr Dev Nutr. 2022 Mar 28;6(5):nzac045. doi: 10.1093/cdn/nzac045. eCollection 2022 May.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 2: 5+5+5 & PDH and Group 3: 5+5+5 & PDH lite+mHealth in people with Underweight Children Aged 6-23 Month Old (WAZ < -1), run by National Institute of Public Health, Cambodia at 3 sites in Cambodia.
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 2 inclusion and 2 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cambodia. 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?
Change in prevalence of underweight children over time (time frame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)). 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 NCT03399058, which also lists 1 linked publication.
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 4 Mar 2021.