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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2021 |
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Main ID: |
NCT03399058 |
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Date of registration:
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22/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Innovative Nutrition and mHealth Evidence Building Project
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Scientific title:
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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 |
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Date of first enrolment:
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November 27, 2017 |
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Target sample size:
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840 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03399058 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Cambodia
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Underweight Children Aged 6-23 Month Old (WAZ < -1)
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Intervention(s)
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Behavioral: Group 3: 5+5+5 & PDH lite+mHealth
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Behavioral: Group 2: 5+5+5 & PDH
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Other: Group 1 5+5+5 (Control)
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Primary Outcome(s)
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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)]
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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]
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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)]
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Change in mean of weight (grams) over time
[Time Frame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)]
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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)]
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Change in prevalence of underweight children over time
[Time Frame: Measured at Baseline (Month 0), Midline (Month 3), Endline (Month 12)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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