Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03229629 |
| Other study ID # |
EWEDP healthy eating |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 25, 2017 |
| Est. completion date |
June 30, 2018 |
Study information
| Verified date |
March 2022 |
| Source |
Cornell University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Pre-school undernutrition is a global problem with life long adverse consequences. One form
of undernutrition, chronic undernutrition or stunting, affects 171 million children under the
age of 5 worldwide. 35% of these children live in Africa. In Ethiopia, the focus of this
study, in 2014, 44.5% of children under 5 were stunted. Stunting is the consequence of
several factors including low birth weights, sub-optimal infant and complementary feeding
practices and repeated illness. In Ethiopia, complementary feeding is sub-optimal; only 4% of
children aged 6-24 months met the minimum dietary diversity recommended by WHO.
The investigators hypothesize four main reasons why many children and mothers in Ethiopia
fall short of best practice in terms of meeting nutritional needs and providing appropriate
childcare.
(i) Lack of information on healthy eating and appropriate child-feeding practices; (ii)
Limited affordability; (iii) Limited accessibility to markets and diverse food items; and
(iv) Limited peer effects in spreading information and adopting new practices.
This study will assess the efficacy of the interventions that address these four barriers to
optimal complementary feeding practices in Ethiopia. Using a cluster randomized control
design, mother-father-child pairs in two localities, Holeta and Ejere will be enrolled.
Treatment will be randomized at the garee (village) level. There will be five treatment arms
and a control group: T1, weekly maternal nutrition BCC sessions for four months; T2, weekly
maternal nutrition BCC sessions for four months and weekly paternal nutrition BCC sessions
for three months; T3, receipt of a food voucher for six months; T4, weekly maternal nutrition
BCC sessions for four months and receipt of a food voucher for six months; T5 weekly maternal
nutrition BCC sessions for four months and weekly paternal nutrition BCC sessions for three
months and receipt of a food voucher for six months; and C, a control group. Within
household, recipient of voucher (mother or father) will be randomly selected.
Description:
1. Specific Aim of the study
Aim 1: How does maternal behavior change communication (BCC) on healthy eating affect
knowledge on child feeding, child feeding behavior, and nutritional status of the child?
o Does BCC lead to changes in knowledge about healthy child-feeding and child-feeding
behaviors?
o Does the changes in child-feeding behaviors due to BCC lead to improvements in
nutritional status among young children measured by height-for-age and
weight-for-height?
Aim 2: How do food vouchers affect food consumption and nutritional status?
- Do vouchers lead to increased food consumption and dietary diversity?
- Do vouchers crowd out private spending on food?
- Does the increased food intake due to food vouchers lead to improvements in
nutritional status among young children measured by height-for-age and
weight-for-height?
Aim 3: How does increased accessibility affect food consumption, child-feeding behavior
and nutritional status?
- By sending petty traders of various food items to randomly selected markets with
limited access to diverse food groups, the investigators hypothesize that increased
accessibility to diverse food items will lead to increased food consumption and
dietary diversity.
- Is there complementarity between accessibility and BCC or vouchers?
Aim 4: Is there complementarity between BCC and food voucher? • The investigators will
test whether there is a complementarity between BCC and food vouchers, as those
receiving the BCC would make more informed decisions on food consumption.
Aim 5: Are there peer effects in nutrition education and corresponding behavior change?
o Within treatment groups: As low food diversity is in part due to eating norms in the
community, the investigators will test to what extent peer effects within the treatment
group will play a role in reinforcing nutritional knowledge and in changing household's
food consumption decisions.
o Outside the treatment groups (spillovers): The investigators hypothesize that mothers
receiving BCC will affect eating behaviors of other household members and/or friends.
Aim 6: How do variations in the prices of healthy food impact demand?
o The investigators hypothesize that offering lower price options of healthy but
expensive food such as meat would increase the demand for that food.
o What are the price elasticity of demand for important food items? What is the maximum
price households are willing to pay-i.e., the stoppage rule-for healthy food items?
Aim 7: Is there additional impact of paternal and maternal nutrition BCC sessions on
complementary feeding practice compared to maternal nutrition BCC sessions alone?
o There will be greater improvement in complementary feeding practices when fathers are
engaged in nutrition BCC sessions. Increased fathers' support on purchasing expensive
but nutritious food items and household labor will facilitate the changes.
Aim 8: Is there differential impact of voucher transfer on complementary feeding
practices depending on recipient's gender?
o The investigators will compare the effect of giving vouchers to fathers with giving
vouchers to mothers on complementary feeding practices, food consumption of household,
and health-related outcomes.
2. Detailed intervention component
2.1 Maternal behavior change communication
BCC will be delivered in groups of six through weekly sessions for a duration of 4
months. Key gaps in knowledge and barriers identified through formative studies are also
addressed in the BCC modules.
2.2 Paternal behavior change communication
Materials will be delivered in groups of 6 through weekly sessions for the duration of 3
months.
2.3 Food vouchers
Food vouchers are transferred monthly at the Project Office in Holeta. Eligible
participants will receive 200 ETB, estimated around US$10. The length of the voucher
scheme will be 6 months. Voucher recipient's gender will be randomly selected within
group 3, 4 and 5 to assess whether there is any differential impact on complementary
feeding practices depending on the gender of voucher recipients.
2.4 Access to healthy food
For a random half of the treated and control groups, petty traders with diverse food
items to their localities will be sent to increase accessibility. This is taking into
consideration that some mothers, especially rural residents, have access a limited set
of food items in the markets that they usually visit, lacking dairy products, meat,
green leafy vegetables, and diverse fruits. To bridge this accessibility gap, petty
traders will be sent to some selected markets with dairy products, meat, and various
fruits and vegetables.
2.5 Price variation of healthy foods
The investigators will introduce variation in the prices of healthy foods that are sold
through petty traders to estimate the impact of price on demand. Price variations will
take the form of 10%, 20%, or 30% discounts. While price will be varied by each petty
trader every time, average food prices over the 6-month intervention period will be the
same among all petty traders.
3. Quality assurance plan
o Baseline and follow up data will be collected through mobile-survey to minimize
errors. Commcare software will be used to build mobile survey. Data collected through
mobile survey will be checked for errors and missing data on a daily basis.
- For some variables, predefined rule will be applied within Commcare software using
data validation tools as the data are collected to prevent avoidable errors.
- Principle investigator and co-investigators will take turn and monitor the field
site during data collection stage (both baseline and follow up) and during early
intervention stage to ensure data quality.
- Baseline survey data will be compared to demographic and health survey data to
assess the accuracy, completeness and representativeness of the data. However, for
most variables, there are no external data sources to compare.
- Data dictionary not relevant
- For variable with missing data above 5%, the variable won't be used as control
variables. For main outcome of interest, data will be checked for errors and
missing data on a daily basis. The investigators will revisit the study participant
to minimize missing data.
4. Standard Operating Procedures to address registry operations and analysis activities
4.1 Patient recruitment
The selection of the households that will be eligible to receive interventions will take
place using the census data of Holeta and Ejere that was collected in 2016. To minimize
potential contamination, control and treatment groups will be randomized at garee
(village) level. Upon consent to participate in the study, mothers living in same garee
will form a group to receive BCC education for mothers, and eligible spouse/partner of
the participating mother will be recruited to form a group separately from mother to
receive BCC for fathers.
4.2 Consent process
Women will be recruited from home visits by AFF's enumerators assigned to this study.
Women will be approached by an AFF's enumerator from the study to see if they are
interested in participating. All women in their reproductive age (18-40) will be
informed about the details of the survey and asked to participate in the survey with the
consent form. Enumerators will read all out the consent form before asking for
signature. If they accept, enumerators will conduct the baseline survey, which consists
of demographic and socioeconomic information.
4.3 Survey data collection
When eligible participants are identified, AFF enumerators will meet the participants at
the health posts.
4.4 Sample size assessment
Minimum detectable difference for the cluster-randomized controlled trial was
calculated. Intra-cluster coefficient was calculated using 2011 DHS data for HAZ, WHZ
and child dietary diversity score (DDS). Minimum detectable difference was estimated
with statistical significance of 0.05 and power of 0.8. Six mother-child pair per
cluster was decided on the study area's estimates of birth rates, 50 numbers of clusters
available for each arm. 10% attrition was assumed. Details of power calculation for main
outcomes of interest are shown below.
Detectable difference
• DDS: 0.30 (Mean 1.5, SD 1.05, ICC 0.10)
- HAZ: 0.51 (Mean -1.56, SD 1.75, ICC 0.12)
- WHZ: 0.42 (Mean -0.80, SD 1.44, ICC 0.11)
4.5 Statistical analysis
• Estimation of treatment effects
In this section, the investigators outline the basic estimation approach to measuring
the effect of the treatments on various outcomes. Our basic treatment effects
specification estimates the following equation:
y= β₀ + β₁BCC + β₂Voucher+ β₃BCC&Voucher+ β₄X+ ε where y is the outcome of interest.
BCC, Voucher, and BCC&Voucher are dummy variables equal to 1 if the participant was
randomly assigned to the BCC, voucher group, or the BCC and voucher villages,
respectively, and 0 otherwise. β₁, β₂ and β₃ represent the effect of being assigned to
the specific treatment arm. X is a vector of individual's characteristics including
demographic variables (e.g., age, marital status, birth order, and household size) and
socioeconomic status (e.g., level of education, employment status/history, and household
income and asset). ε is an error term. The outcome variable, y, include mother's
nutritional knowledge score, household food and non-food expenditures, child's dietary
diversity score and FCS, and child's height-for-age (HAZ) and weight-for-height Z scores
(WHZ).
To assess the gender-related impacts of engaging fathers in the BCC program, the
investigators estimate the following equation:
y= β₀ + β₁MotherBCC+ β₂BothBCC+ β₃MotherBCC&Voucher+ β₄BothBCC&Voucher+ β₅X+ ε where
MotherBCC, BothBCC, MotherBCC&Voucher and BothBCC&Voucher are dummy variables equal to 1
if the household was randomly assigned to the mother BCC, mother and father BCC, mother
BCC and voucher, or mother and father BCC and voucher villages, respectively, and 0
otherwise. β₁, β₂, β₃ and β₄ represent the treatment effects.
To assess the differential impacts of randomly giving vouchers to mothers or fathers, a
dummy variable representing the sex of the voucher recipient will be interacted with the
voucher treatment assignment variable. Further, the investigators will implement the
same analysis with a restricted sample by excluding BCC only villages.
The investigators also have random variation in the accessibility to certain food items
in the markets, as a random half of the participants are provided access to additional
goods in the markets. To analyse the effect of increased accessibility on household
expenditures and nutritional outcomes, the investigators estimate the following
equation:
y =α₀+α₁Access+α₂X+α₃P+ ε Where Access is a dummy variable equal to 1 if petty traders
are randomly assigned to markets in village provide lacking food items such as meat,
dairy products, and fruits and vegetables. P is a vector of food prices in village.
Finally, the investigators use network data to estimate whether the treatment also
influenced the outcomes of peers of the participants. The extent of such peer effects or
information spillovers can be estimated with the following specification:
y =α₀+α₁Peer+α₂X+ ε Where y is the outcome of interest for individual i with child less
than four months of age or in pregnancy at the time of baseline survey. Peer is a dummy
variable equal to 1 if respondent has a peer in cluster who is assigned to BCC or BCC
and voucher treatment group.
