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Innovative Nutrition and mHealth Evidence Building Project

Primary Purpose

Underweight Children Aged 6-23 Month Old (WAZ < -1)

Status
Completed
Phase
Not Applicable
Locations
Cambodia
Study Type
Interventional
Intervention
Group 1 5+5+5 (Control)
Group 2: 5+5+5 & PDH
Group 3: 5+5+5 & PDH lite+mHealth
Sponsored by
National Institute of Public Health, Cambodia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Underweight Children Aged 6-23 Month Old (WAZ < -1)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Enrollment:

  • 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)

Exclusion Criteria:

  • No access to mobile phone
  • Severe Acute malnutrition (Weight for Height Z-score <-3), Edema

Sites / Locations

  • ADP Samrong Tong 2
  • ADP Boribor 2
  • ADP Rolea Phaea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Group 1 5+5+5 (Control)

Group 2: 5+5+5 & PDH

Group 3: 5+5+5 & PDH lite+mHealth

Arm Description

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).

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.

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).

Outcomes

Primary Outcome Measures

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).
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).
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 22, 2017
Last Updated
March 2, 2021
Sponsor
National Institute of Public Health, Cambodia
Collaborators
World Vision International, World Vision, Hong Kong, World Vision, Cambodia, Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT03399058
Brief Title
Innovative Nutrition and mHealth Evidence Building Project
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Public Health, Cambodia
Collaborators
World Vision International, World Vision, Hong Kong, World Vision, Cambodia, Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Underweight Children Aged 6-23 Month Old (WAZ < -1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
840 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 5+5+5 (Control)
Arm Type
Other
Arm Description
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).
Arm Title
Group 2: 5+5+5 & PDH
Arm Type
Other
Arm Description
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.
Arm Title
Group 3: 5+5+5 & PDH lite+mHealth
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Group 1 5+5+5 (Control)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Group 2: 5+5+5 & PDH
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Group 3: 5+5+5 & PDH lite+mHealth
Intervention Description
The participants in the third group will receive a PDH lite program and receive follow-up through mobile support phone calls (Group 3).
Primary Outcome Measure Information:
Title
Change in prevalence of underweight children over time
Description
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).
Time Frame
Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Title
Change in mean of weight (grams) over time
Description
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).
Time Frame
Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Title
Change in percentage of caregivers correctly answering questions on child feeding, hygiene, health-seeking and caring practices over time
Description
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.
Time Frame
Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Title
Change in percentage of caregivers who have adopted proper child feeding, hygiene, health-seeking, and caring practices
Description
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.
Time Frame
Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Title
Change in percentage of caregivers self-reporting confidence in ability to adopt proper child feeding, hygiene, health-seeking, and caring practices over time
Description
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.
Time Frame
Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
Title
Assess the percentage of siblings of enrolled children in each group with a weight for height z-score <-2
Description
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.
Time Frame
Measured at Year 2 Endline

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Enrollment: 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) Exclusion Criteria: No access to mobile phone Severe Acute malnutrition (Weight for Height Z-score <-3), Edema
Facility Information:
Facility Name
ADP Samrong Tong 2
City
Kampong Speu
State/Province
Kamong Speu
Country
Cambodia
Facility Name
ADP Boribor 2
City
Kampong Chhnang
Country
Cambodia
Facility Name
ADP Rolea Phaea
City
Kampong Chhnang
Country
Cambodia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35611354
Citation
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.
Results Reference
derived

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Innovative Nutrition and mHealth Evidence Building Project

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