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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01676623
Other study ID # IFPRI-S-01 (2)
Secondary ID
Status Completed
Phase N/A
First received August 29, 2012
Last updated February 29, 2016
Start date April 2010
Est. completion date December 2014

Study information

Verified date February 2016
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 4000
Est. completion date December 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 60 Months
Eligibility Inclusion Criteria:

- Children 0-60 months of age

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Standard government health services
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 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.
Mass media campaign
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.

Locations

Country Name City State
Vietnam Alive & Thrive & International Food Policy Research Institute Hanoi

Sponsors (2)

Lead Sponsor Collaborator
International Food Policy Research Institute FHI 360

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Secondary 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 4 years No
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