NCT03229629

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,243

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

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

June 25, 2017

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

July 2, 2017

Last Update Submit

March 8, 2022

Conditions

MalnutritionStunted GrowthGrowthFeeding, Complementary

Keywords

Behavior change communicationEthiopiaFood vouchercomplementary feeding practiceaffordabilityaccessibilitygender

Outcome Measures

Primary Outcomes (3)

  • Nutrition knowledge

    Mean difference of nutrition knowledge score

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

  • Child dietary diversity score

    Mean difference in child dietary diversity score defined by consumption of number of food group consumed by a child.

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

  • Food consumption score

    Mean difference in food consumption score calculated using the frequency of consumption of different food groups consumed by a child.

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

Secondary Outcomes (4)

  • Change in length-for-age Z scores

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

  • Change in weight-for-height Z scores

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

  • Mid-Upper Arm Circumference

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

  • Social support actions of father

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

Other Outcomes (12)

  • Household hygiene environment and practice

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

  • Minimum dietary diversity

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

  • Minimum meal frequency

    Measured at baseline and endline. Time frame between baseline and endline will be approximately 6 months.

  • +9 more other outcomes

Study Arms (6)

Maternal BCC only

EXPERIMENTAL

Mothers with child under 20 months or pregnant will receive Behavior Change Communication (BCC)

Behavioral: Behavior change communication

Maternal BCC & Paternal BCC

EXPERIMENTAL

1. Mothers with child under 20 months or pregnant will receive BCC 2. Husband/partner of the enrolled mother will receive BCC \*BCC: Behavior Change Communication

Behavioral: Behavior change communication

Food voucher

EXPERIMENTAL

1. Mothers or fathers with child under 20 months or pregnant will receive monthly food voucher worth 200 birr(\~$10) 2. Within household, recipient of voucher (mother or father) will be randomly selected. * Food voucher

Other: Food Voucher (Monetary)

Maternal BCC & Food Voucher

EXPERIMENTAL

1. Mothers with child under 20 months or pregnant will receive BCC 2. Mothers or fathers with child under 20 months or pregnant will receive monthly food voucher worth 200 birr(\~$10) 3. Within household, recipient of voucher (mother or father) will be randomly selected. * BCC: Behavior Change Communication

Behavioral: Behavior change communicationOther: Food Voucher (Monetary)

Maternal BCC&Paternal BCC &Food Voucher

EXPERIMENTAL

1. Mothers with child under 20 months or pregnant will receive BCC 2. Husband/partner of the enrolled mother will receive BCC 3. Enrolled participants will receive monthly voucher worth 200 birr(\~$10) 4. Within household, recipient of voucher (mother or father) will be randomly selected. * BCC: Behavior Change Communication

Behavioral: Behavior change communicationOther: Food Voucher (Monetary)

Control

NO INTERVENTION

Control group

Interventions

Behavior change communicationBEHAVIORAL

Weekly behavior change communication (BCC) to mothers for the duration of 16 weeks Weekly behavior change communication (BCC) to fathers for the duration of 12 weeks

Maternal BCC & Food VoucherMaternal BCC & Paternal BCCMaternal BCC onlyMaternal BCC&Paternal BCC &Food Voucher
Food Voucher (Monetary)OTHER

Monthly voucher worth 200 birr(\~$10) every month for the duration of 6 month

Food voucherMaternal BCC & Food VoucherMaternal BCC&Paternal BCC &Food Voucher

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female: Women aged between 18-40 who is pregnant or have children 20 months or younger
  • Male: Spouse/partner of the women recruited in the study (no age limit for fathers)
  • Child of the women recruited in the study

You may not qualify if:

  • Those who are not able to understand the consent form
  • Those without the physical ability to come to the health post

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Africa Future Foundation Ethiopia

B/m/h/395/98, Goro Kerensa, Holeta Town, Oromiya, Ethiopia

Location

Related Publications (1)

  • Han Y, Park S, Kim J, Hoddinott J. Engaging Fathers Through Nutrition Behavior Communication Change Does Not Increase Child Dietary Diversity in a Cluster Randomized Control Trial in Rural Ethiopia. J Nutr. 2023 Feb;153(2):569-578. doi: 10.1016/j.tjnut.2022.12.023. Epub 2022 Dec 28.

    PMID: 36894248DERIVED

MeSH Terms

Conditions

MalnutritionGrowth DisordersCoitus

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

Study Officials

  • Hyuncheol Kim

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Cluster randomised controlled trial Clustered at the village level, 5 treatment arms and one control group Within three treatment arms, voucher will be individually randomised
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2017

First Posted

July 25, 2017

Study Start

June 25, 2017

Primary Completion

March 31, 2018

Study Completion

June 30, 2018

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

ET(1)