NCT02775552

Brief Summary

Alive \& Thrive is an initiative that aims to scale up nutrition to save lives, prevent illness, and ensure healthy growth and development through improved infant young child feeding (IYCF) practices. The purpose of this study is to evaluate whether the Alive \& Thrive intervention package, consisting of interpersonal communication, community mobilization activities, and radio campaign, can increase complementary feeding practices (minimum dietary diversity and minimum meal frequency) while sustaining exclusive breastfeeding rate among children less than two years of age. The impact evaluation uses a cluster-randomized design where 20 geographic clusters (woredas/districts) were randomized to two study arms - 10 intervention areas and 10 comparison areas. Repeated cross-sectional baseline and endline surveys will be used to assess program impact.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

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

March 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

May 12, 2016

Last Update Submit

February 23, 2018

Conditions

Exclusive BreastfeedingComplementary Feeding

Keywords

Child NutritionBreastfeedingComplementary FeedingInfant and Young Child FeedingSocial and Behavior Change CommunicationEthiopia

Outcome Measures

Primary Outcomes (3)

  • Exclusive breastfeeding among children aged 0-5.9 months in the intervention areas only

    The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.

    2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

  • Minimum dietary diversity among children aged 6-23.9 months

    The proportion of children aged 6-23.9 months months who received foods from 4 or more food groups on the day preceding the interview.

    2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

  • Minimum meal frequency of (semi) solid or soft foods among children aged 6-23.9 months

    The proportion of children aged 6-23.9 months who received (semi) solid or soft foods the minimum number of times or more on the day preceding the interview.

    2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

Secondary Outcomes (8)

  • Early initiation of breastfeeding among children aged 0-5.9 months in the intervention areas only and among children aged 6-23.9 months in intervention and comparison areas

    2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

  • Continued breastfeeding at 1 year among children aged 12-15.9 months

    2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

  • Timely introduction of (semi) solid or soft foods among children aged 6-8.9 months

    2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

  • Minimum acceptable diet among children aged 6-23.9 months

    2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

  • Consumption of iron-rich foods among children aged 6-23.9 months

    2 years after baseline in a cross-sectional endline survey scheduled for March-April 2017

  • +3 more secondary outcomes

Study Arms (2)

A&T intervention areas

EXPERIMENTAL
Behavioral: A&T community-based interventionsBehavioral: Mass media

Comparison areas

ACTIVE COMPARATOR

(Receive standard government services)

Behavioral: Mass media

Interventions

A&T community-based interventionsBEHAVIORAL

1. Interpersonal communication delivered by health workers and community volunteers at the health post and during home visits to: \- Increase mothers' knowledge about adequate child feeding practices 2. Interpersonal communication delivered by agricultural extension workers to: \- Increase fathers' knowledge about nutrition-sensitive agriculture and child feeding 3. Community mobilization activities to: * Raise awareness of child feeding practices among community members, and increase support to mothers (enhanced community conversations) * Increase mothers' knowledge about preparation of complementary foods (cooking demonstrations) * Raise awareness of adequate child feeding during fasting among family and community members (church sermons) 4. Enhanced training of government health and agricultural extension workers in infant and young child feeding to: * Improve their ability to provide timely and appropriate information and support to mothers and families

A&T intervention areas
Mass mediaBEHAVIORAL

Radio campaign - radio drama series, spots, and jingles

A&T intervention areasComparison areas

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Gives informed consent
  • Being aged from 15 to 49 years (women of reproductive age)
  • Has at least one infant less than 24 months old who is currently alive and lives with her

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Food Policy Research Institute

Addis Ababa, Ethiopia

Location

Related Publications (2)

  • Kim SS, Nguyen PH, Tran LM, Alayon S, Menon P, Frongillo EA. Different Combinations of Behavior Change Interventions and Frequencies of Interpersonal Contacts Are Associated with Infant and Young Child Feeding Practices in Bangladesh, Ethiopia, and Vietnam. Curr Dev Nutr. 2019 Dec 9;4(2):nzz140. doi: 10.1093/cdn/nzz140. eCollection 2020 Feb.

    PMID: 31976385DERIVED

  • Kim SS, Nguyen PH, Yohannes Y, Abebe Y, Tharaney M, Drummond E, Frongillo EA, Ruel MT, Menon P. Behavior Change Interventions Delivered through Interpersonal Communication, Agricultural Activities, Community Mobilization, and Mass Media Increase Complementary Feeding Practices and Reduce Child Stunting in Ethiopia. J Nutr. 2019 Aug 1;149(8):1470-1481. doi: 10.1093/jn/nxz087.

    PMID: 31165869DERIVED

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Purnima Menon, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

  • Sunny S. Kim, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 17, 2016

Study Start

March 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

ET(1)