NCT01676623

Brief Summary

Alive \& Thrive is an initiative that aims to improve infant and young child feeding practices and reduce childhood stunting. In Vietnam, Alive \& Thrive's primary intervention is implemented through a social franchise linked with the government's health system. The impact evaluation is conducted using a cluster-randomized design in which 20 commune health centers (CHC) were assigned to the social franchise model, and 20 CHC were assigned to routine government services. Repeated cross-sectional baseline and endline surveys will be used to assess the public health impact of this intervention. The baseline was in 2010 and an endline survey in the same communities will be conducted in 2014. Mixed methods process evaluation will be conducted in 2011, 2012 and 2013 to study the pathways through which the program impact is achieved.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Longer than P75 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

April 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

4.3 years

First QC Date

August 29, 2012

Last Update Submit

February 29, 2016

Conditions

Keywords

Child nutritionStuntingExclusive breastfeedingComplementary feedingSocial franchiseMass mediaCounselingFacility-based

Outcome Measures

Primary Outcomes (3)

  • Exclusive breastfeeding among children 0-6 months of age

    Exclusive breastfeeding in children 0-6 months of age is one of the eight WHO-recommended IYCF core indicators will be measured to capture breastfeeding and complementary feeding practices. It is measured using survey based recall by interviewing mothers of children in the age group for the indicator.

    4 years

  • Child heights and weights (children 24-60 months of age)

    Heights and weights of children in the intervention and comparison communes covered by the CHCs in the study will be assessed in 2014. A new sample of children 24-60 months will be measured in the repeated cross-sectional endline survey to measure these outcomes and compute height-for-age, weight-for-age and weight-for-height z-scores based on the WHO growth reference standards.

    4 years

  • Complementary feeding for children 6-23.9 months of age

    Indicators of complementary feeding - diet diversity, minimum acceptable diet, and minimum meal frequency, measured in children 6-23.9 months of age are one of the eight WHO-recommended IYCF core indicators will be measured to capture breastfeeding and complementary feeding practices. These are measured using survey based recall by interviewing mothers of children in the age group for the indicator.

    4 years

Secondary Outcomes (1)

  • Early initiation of breastfeeding in children 0-24 months of age

    4 years

Study Arms (2)

Comparison area, only standard government services

ACTIVE COMPARATOR

This intervention arm will receive the standard government services offered at CHCs all over Vietnam. In addition, participants in this arm will be exposed to the nationwide mass media campaign.

Behavioral: Standard government health servicesBehavioral: Mass media campaign

A&T Franchise

EXPERIMENTAL

In this arm, the 20 CHCs will offer Alive \& Thrive branded franchise services with enhanced quality of IYCF counseling through interpersonal contact between health workers at the commune level and clients who use the commune health services. In addition, the clients could also be exposed to the mass media campaign.

Behavioral: Standard government health servicesBehavioral: Alive & Thrive IYCF franchise servicesBehavioral: Mass media campaign

Interventions

This intervention will be basic preventive and curative health services provided by the commune health centers. This includes antenatal care, postnatal care and basic nutrition related counseling.

A&T FranchiseComparison area, only standard government services

This intervention includes intensive behavioral counseling to improve infant and young child feeding. A package of 15 counseling contacts that are quality assured and branded will be offered to families of infants and young children. Services might also include user fees.

A&T Franchise

Alive \& Thrive is implementing a nationwide mass media campaign in 2011, 2012 and 2013, with a focus on improving breastfeeding practices. The mass media intervention includes TV and radio spots as well as an internet site and a telephone hotline.

A&T FranchiseComparison area, only standard government services

Eligibility Criteria

AgeUp to 60 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children 0-60 months of age

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alive & Thrive & International Food Policy Research Institute

Hanoi, Hanoi, Vietnam

Location

Related Publications (4)

  • 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.

  • Nguyen PH, Kim SS, Tran LM, Menon P, Frongillo EA. Intervention Design Elements Are Associated with Frontline Health Workers' Performance to Deliver Infant and Young Child Nutrition Services in Bangladesh and Vietnam. Curr Dev Nutr. 2019 Jul 10;3(8):nzz070. doi: 10.1093/cdn/nzz070. eCollection 2019 Aug.

  • Rawat R, Nguyen PH, Tran LM, Hajeebhoy N, Nguyen HV, Baker J, Frongillo EA, Ruel MT, Menon P. Social Franchising and a Nationwide Mass Media Campaign Increased the Prevalence of Adequate Complementary Feeding in Vietnam: A Cluster-Randomized Program Evaluation. J Nutr. 2017 Apr;147(4):670-679. doi: 10.3945/jn.116.243907. Epub 2017 Feb 8.

  • Menon P, Nguyen PH, Saha KK, Khaled A, Kennedy A, Tran LM, Sanghvi T, Hajeebhoy N, Baker J, Alayon S, Afsana K, Haque R, Frongillo EA, Ruel MT, Rawat R. Impacts on Breastfeeding Practices of At-Scale Strategies That Combine Intensive Interpersonal Counseling, Mass Media, and Community Mobilization: Results of Cluster-Randomized Program Evaluations in Bangladesh and Viet Nam. PLoS Med. 2016 Oct 25;13(10):e1002159. doi: 10.1371/journal.pmed.1002159. eCollection 2016 Oct.

Related Links

MeSH Terms

Conditions

Growth DisordersBreast Feeding

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Purnima Menon, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR
  • Rahul Rawat, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR
  • Phuong Nguyen, PhD

    International Food Policy Research Institute

    PRINCIPAL INVESTIGATOR
  • Marie T Ruel, 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

August 29, 2012

First Posted

August 31, 2012

Study Start

April 1, 2010

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

March 2, 2016

Record last verified: 2016-02

Locations