Clinical trial NCT03399058: 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
Overall status: COMPLETED
Phase: NA
Conditions: Underweight Children Aged 6-23 Month Old (WAZ < -1)
Lead sponsor: National Institute of Public Health, Cambodia
Sponsor class: OTHER_GOV
Collaborators: name: World Vision International
name: World Vision, Hong Kong
name: World Vision, Cambodia
name: Emory University
First posted: 2018-01-16
Enrollment: 840
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in prevalence of underweight children over time
timeFrame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
measure: Change in mean of weight (grams) over time
timeFrame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
measure: Change in percentage of caregivers correctly answering questions on child feeding, hygiene, health-seeking and caring practices over time
timeFrame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
measure: Change in percentage of caregivers who have adopted proper child feeding, hygiene, health-seeking, and caring practices
timeFrame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
measure: Change in percentage of caregivers self-reporting confidence in ability to adopt proper child feeding, hygiene, health-seeking, and caring practices over time
timeFrame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)
measure: Assess the percentage of siblings of enrolled children in each group with a weight for height z-score <-2
timeFrame: Measured at Year 2 Endline
Secondary outcomes:
Other outcomes:
Locations:
city: Kampong Speu
country: Cambodia
facility: ADP Samrong Tong 2
state: Kamong Speu
city: Kampong Chhnang
country: Cambodia
facility: ADP Boribor 2
city: Kampong Chhnang
country: Cambodia
facility: ADP Rolea Phaea
Study officials:
References:
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.