Innovative Nutrition and mHealth Evidence Building Project

National Institute of Public Health, Cambodia

Status: Completed

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

Treatments: Other: Group 1 5+5+5 (Control); Behavioral: Group 2: 5+5+5 & PDH; Behavioral: Group 3: 5+5+5 & PDH lite+mHealth

Study type: Interventional

Funder types: Other

Identifiers

NCT03399058

156NECHR

Details and patient eligibility

About

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.

Enrollment: 840 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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840 participants in 3 patient groups

Group 1 5+5+5 (Control)

Other group

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).

Treatment:

Other: Group 1 5+5+5 (Control)

Group 2: 5+5+5 & PDH

Other group

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.

Treatment:

Behavioral: Group 2: 5+5+5 & PDH

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

Other group

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).

Treatment:

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