NCT02903641

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
506

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

September 7, 2016

Last Update Submit

February 25, 2017

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • Household spending

    Household spending on key foods (meat/fish, fruits and vegetables, eggs, milk/dairy products, legumes)

    6 weeks after baseline/intervention

Secondary Outcomes (3)

  • Caregiver perception of child's relative height

    6 weeks after baseline/intervention

  • Caregiver satisfaction with child's height

    6 weeks after baseline/intervention

  • Caregiver knowledge of how to improve child's growth

    6 weeks after baseline/intervention

Study Arms (4)

Control

NO INTERVENTION

All households in the study were given general child nutrition educational messaging, immediately after the baseline survey and prior to any treatments. This messaging focused on appropriate feeding habits complemented by breastfeeding and ways to maintain proper hygiene during food preparation and consumption.

Personalized information only

EXPERIMENTAL

Household received the personalized information about the index child's height.

Behavioral: Personalized information

Labeled cash transfer only

EXPERIMENTAL

Household received the labeled cash transfer.

Behavioral: Labeled cash transfer

Personalized information and labeled cash transfer

EXPERIMENTAL

The household received both the personalized information intervention and labeled cash transfer intervention.

Behavioral: Personalized informationBehavioral: Labeled cash transfer

Interventions

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.

Personalized information and labeled cash transferPersonalized information only

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.

Labeled cash transfer onlyPersonalized information and labeled cash transfer

Eligibility Criteria

Age14 Months - 55 Months
Sexall
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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. doi: 10.1093/jn/132.6.1180.

    PMID: 12042431BACKGROUND
  • 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. doi: 10.1093/jn/134.10.2579.

    PMID: 15465751BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Katherine Donato, MA

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 16, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 28, 2017

Record last verified: 2017-02