AzTrials
AzTrials

Child NutritionNCT01676623

Impact Evaluation of a Social Franchise Model for Improving Infant and Young Child Feeding and Child Nutrition in Vietnam

A study testing Standard government health services, Alive & Thrive IYCF franchise services and Mass media campaign in people with Child Nutrition and Stunting, run by International Food Policy Research Institute at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 60 monthsHealthy volunteers can take part
Conditions the study is for
Child Nutrition, Stunting, Exclusive Breastfeeding
What is being tested?
Standard government health services, Alive & Thrive IYCF franchise services and Mass media campaign
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,000 participants
Where
1 siteVietnam
Study dates
Apr 2010to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 60 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children 0-60 months of age

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Alive & Thrive & International Food Policy Research Institute

    Hanoi, Hanoi

Other trials in Vietnam

About this study

Official title: Impact Evaluation of a Social Franchise Model Implemented by Alive & Thrive for Improving Infant and Young Child Feeding and Child Nutrition in Rural Vietnam

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.

Read the detailed description

Link provided to journal manuscript describing design of evaluation provides additional detail: http://fnb.sagepub.com/content/34/3_suppl2/S195.full.pdf

Being tested
Standard government health services, Alive & Thrive IYCF franchise services, Mass media campaign
Keywords
Child nutrition, Stunting, Exclusive breastfeeding, Complementary feeding, Social franchise, Mass media, Counseling, Facility-based
Medical subject headings
Growth Disorders, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard government health servicesBehavioural

    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.

  • Alive & Thrive IYCF franchise servicesBehavioural

    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.

  • Mass media campaignBehavioural

    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.

Study groups in NCT01676623
Study groupRoleWhat they receive
Comparison area, only standard government servicesActive comparatorThis 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.
Receives: Behavioral: Standard government health services; Behavioral: Mass media campaign
A&T FranchiseExperimentalIn 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.
Receives: Behavioral: Standard government health services; Behavioral: Alive & Thrive IYCF franchise services; Behavioral: Mass media campaign

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 years

  2. 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.

    Measured: 4 years

  3. 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.

    Measured: 4 years

Secondary outcomes (1)

  1. Early initiation of breastfeeding in children 0-24 months of age

    Early initiation of breastfeeding (in the first hour after birth) is measured in children 0-23.9 months of age and it is 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. Samples for children 0-6 months and 6-23.9 are combined to calculate this indicator

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2012 (estimated)
  2. Study startApr 2010
  3. Primary completionJul 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01676623
Sponsor's protocol ID
IFPRI-S-01 (2)
Status last verified
Feb 2016
First submitted
29 Aug 2012
Last updated
2 Mar 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31976385

  • 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.

    PubMed 31346584

  • 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.

    PubMed 28179488

  • 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.

    PubMed 27780198

Questions about this trial

What is this clinical trial studying?

A study testing Standard government health services, Alive & Thrive IYCF franchise services and Mass media campaign in people with Child Nutrition and Stunting, run by International Food Policy Research Institute at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exclusive breastfeeding among children 0-6 months of age (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01676623, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in