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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02903641
Other study ID # 14-3255-1
Secondary ID
Status Completed
Phase N/A
First received September 7, 2016
Last updated February 25, 2017
Start date July 2016
Est. completion date September 2016

Study information

Verified date February 2017
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Malnutrition accounts for nearly half of child deaths worldwide. Children who are well-nourished are better able to learn in school, grow into more physically capable adults, and require less health care during childhood and adulthood. Moreover, it is difficult to make up for poor childhood nutrition later in life. I present here the proposal for an intervention that builds on a larger study in Ethiopia and will generate insights into the importance of behavioral factors related to persistent malnutrition in low-income settings, allowing for more targeted, cost-effective interventions in the future.

Existing data from the study region, Oromia, Ethiopia, suggest that many mothers know how to correctly respond to a hypothetical situation where a young child exhibits poor growth. On the other hand, however, mothers frequently appear unaware about their own children's growth deficiencies. Together, these facts suggest that false beliefs about the appropriateness of a child's physical size are a more likely contributor to malnutrition, rather than a weak understanding of how to help a malnourished child.

The proposed intervention will provide evidence on the relationship between caregiver beliefs about child nutritional status and the caregiver's behavior, ultimately analyzing how this relationship influences important nutritional choices for young children in a setting with limited resources. The study uses a two-by-two randomized trial; the first treatment is a cash transfer labeled for child food consumption, and the second is the provision of personalized information about the quality of the child's height compared to other children like those of the same age and gender in East Africa. Together the two treatment arms will provide evidence about the relative importance of behavioral versus resource barriers to improved nutrition. Better understanding of the interaction between these key factors is essential in addressing one of the foremost health issues facing developing countries today.


Recruitment information / eligibility

Status Completed
Enrollment 506
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers
Gender All
Age group 14 Months to 55 Months
Eligibility Households for this study were selected from among those who were included in any of the three study groups from a larger study and for whom relevant data had been collected.

Inclusion Criteria:

- inclusion in the larger study required the household to have a child who was 6-35 months old for the main study's baseline survey in July-August 2015 (referred to as the index child) and for the household to have land for crop cultivation

Exclusion Criteria:

- Households that did not meet the inclusion restriction or those who did not have anthropometric data collected during the larger study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Personalized information
During a prior study in June-July 2016, we collected anthropometric measures on the index children, including the children's height. Based on these data, for households assigned to the information treatment, enumerators provided personalized information to the children's primary caregiver about the index child's current height, during a baseline household visit. The enumerators carried a display card that visually showed where the child's height fell compared to "healthy" children of the same age and gender like those in East Africa. The enumerators emphasized to the caregivers that short stature is due to poor chronic malnutrition and is not just attributable to genetics or a recent illness. During this visit, the enumerators additionally pointed out that chronic malnutrition is not immediately life-threatening.
Labeled cash transfer
Households received a cash transfer labeled for child food consumption and were told the money is designed to cover additional spending for food for the index child (and any other younger children in the household) over the next six weeks. Though it was given as a single, lump sum payment, the transfer was evenly split and handed to the household in six sealed envelopes, to help the households better allocate the money. To further encourage them not to spend the money all at once, each envelope was labeled with a number, the index child's name, and the dates for the week the money in the envelope should be spent. Enumerators clearly stated that this is a one-time money transfer.

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Harvard School of Public Health Harvard Center for African Studies, Harvard Foundations of Human Behavior, Vogelheim Hansen Fund, Weiss Family Program Fund

References & Publications (2)

Arimond M, Ruel MT. Dietary diversity is associated with child nutritional status: evidence from 11 demographic and health surveys. J Nutr. 2004 Oct;134(10):2579-85. — View Citation

Ruel MT, Menon P. Child feeding practices are associated with child nutritional status in Latin America: innovative uses of the demographic and health surveys. J Nutr. 2002 Jun;132(6):1180-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Dietary diversity Number of foods that index child consumed in past 24 hours from among: grains, tubers, milk, vitamin-A rich fruits and vegetables (e.g., pumpkins, carrots, dark leafy vegetables, mangoes, papayas), other fruits and vegetables, animal protein foods, and legumes, as measured through an interview with the child's caregiver at 6 weeks post intervention 6 weeks after baseline/intervention
Primary Food frequency Number of days in past week that index child consumed key foods (meat/fish, fruits, vegetables, eggs, milk/dairy products, legumes), as measured through an interview with the child's caregiver at 6 weeks post intervention 6 weeks after baseline/intervention
Primary Meal frequency Number of times child was fed in previous 24 hours; assessed separately depending on whether child is still breastfeeding, and by age group (<24 months, 24-36 months, >36 months), as measured through an interview with the child's caregiver at 6 weeks post intervention 6 weeks after baseline/intervention
Primary Infant and child feeding index Total score from: Dietary diversity (0 or 1 foods = 0 points, 2-3 foods = 1 point, 4+ foods=2 points), food frequency (0 days = 0 point, 1-3 days = 1 point, 4+ days = 2 points), breastfeeding (1 point; relevant for children up to 36 months), and meal frequency (0-1 meals = 0 points, 2 meals = 1 point, 3 meals = 2 points, 4+ meals = 3 points), as measured through an interview with the child's caregiver at 6 weeks post intervention 6 weeks after baseline/intervention
Primary Household spending Household spending on key foods (meat/fish, fruits and vegetables, eggs, milk/dairy products, legumes) 6 weeks after baseline/intervention
Secondary Caregiver perception of child's relative height 6 weeks after baseline/intervention
Secondary Caregiver satisfaction with child's height 6 weeks after baseline/intervention
Secondary Caregiver knowledge of how to improve child's growth 6 weeks after baseline/intervention
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