Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01678716
Other study ID # AED ARTS/IFPRI-S-01
Secondary ID IFPRI-107033
Status Completed
Phase N/A
First received August 29, 2012
Last updated February 29, 2016
Start date April 2010
Est. completion date July 2014

Study information

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

Clinical Trial Summary

This complex evaluation of a large-scale program uses a cluster-randomized design where 20 geographic clusters (subdistricts) were randomized to study two sets of interventions. For the evaluation of behavior change interventions only, the 20 clusters were randomized to 10 intensive and 10 non-intensive interventions areas. For a sub-study to evaluate a market-based model for delivering micronutrient powders (MNP) along with behavior change interventions, there was subsequent randomization to comparison area, MNP-only area, Behavior Change Communication (BCC)-only area and MNP+BCC areas.


Description:

The design uses a repeated cross-sectional design, with multiple age-group samples for multiple outcomes [since each set of outcomes can only be assessed in the relevant age group for the outcome; e.g., exclusive breastfeeding is only assessed in children 0-6 months of age]. These include:

1. For the evaluation of behavior change intervention only:

- 0-6 months for breastfeeding outcomes

- 6-23.9 months for complementary feeding outcomes (in the behavior change intervention evaluation)

- 24-48 months for child anthropometric outcomes (related to the behavior change interventions).

2. for the substudy on behavior change and micronutrient powder interventions combined - 6-23.9 months for anemia and anthropometric outcomes

A community-based random sample of children 0-6 months, 6-23.9 months, 24-48 months old was surveyed at baseline (April-June 2010). The original anemia sub-study design had proposed surveying children 6.23.9 months of age for the MNP intervention in April-June 2013 and for the behavior change intervention in April-June 2014. Based on program implementation timelines, the endline survey dates were extended by one year such that the above age groups were then sampled and surveyed in community-based surveys in April-June 2014.

Infant feeding practices will be assessed using before-after intervention-comparison area group differences between 2010, and 2013 and 2014. Specifically, breast feeding will be assessed in children 0-6 months of age (sampled separately) and complementary feeding will be assessed in children 6-23.9 months of age (sampled separately).

Stunting will be assessed in the sample of children 24-48 months of age using before-after intervention-comparison group differences between 2010 and 2014.

In addition, the investigators will evaluate the processes through which the programs roll out using a mix of qualitative and quantitative research methods. Qualitative research methods will help to understand drivers of promotion and sales of MNPs by frontline health workers, as well as household level determinants and dynamics related to enabling purchase and use of the MNP and adhering to behavioral recommendations. Quantitative surveys of frontline health workers will help document their awareness about IYCF, MNPs, training, and sales, while quantitative surveys of the households will help document household level awareness, purchase and use of MNPs and awareness and adherence to IYCF practices for children in the target age range.


Recruitment information / eligibility

Status Completed
Enrollment 8800
Est. completion date July 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:

- Child age < 60 months

Study Design

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


Intervention

Behavioral:
EHC + BCC
This arm includes home visits to mothers with infants and young children. Frontline health workers will counsel and support mothers in relation to breastfeeding and complementary feeding practices
Dietary Supplement:
Micronutrient powders
In this intervention arm, frontline health workers will visit households and promote and sell micronutrient powders to them. The micronutrient powder is sold by the brand name "Pushtikona" in Bangladesh and contains 15 micronutrients including iron, zinc, vitamin A, vitamin C, and others.
Behavioral:
Mass media
A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.

Locations

Country Name City State
Bangladesh International Food Policy Research Institute Dhaka

Sponsors (1)

Lead Sponsor Collaborator
International Food Policy Research Institute

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exclusive breastfeeding (EBF) among children 0-6 months of age EBF is among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures 4 years after baseline No
Primary Child anthropometry (height, weight) among children 24-48 months of age Child height and weight will be measured among the repeated cross-sectional of children living in the study villages. These will be converted into z-scores based on the WHO growth reference standards. 4 years after baseline No
Primary Complementary feeding among children 6-23.9 months of age Complementary feeding indicators that include timely introduction of complementary feeding (infants 6-8 months), dietary diversity, minimum dietary diversity, minimum dietary diversity, are among the eight WHO-recommended core indicators for infant and young child feeding and will be measured using recall-based survey measures in this age group. 4 years after baseline No
Primary Anemia among children 6-23.9 months Anemia will be measured using Hemocue 4 years after baseline No
Secondary Iron deficiency Iron deficiency is measured using serum ferritin and serum tranferrin receptor. Assessments are done using capillary blood. 3 years No
See also
  Status Clinical Trial Phase
Completed NCT00579605 - Motivational Interviewing to Promote Sustained Breastfeeding N/A
Completed NCT05655364 - Development of a Breastfeeding Supportive Mobile Application N/A
Completed NCT03853850 - Using Mobile Phone Text Messaging System to Improve Exclusive Breastfeeding Rate in a Resource-poor Caribbean Island N/A
Completed NCT03957941 - FamilyLink and Breastfeeding N/A
Withdrawn NCT03709004 - Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression N/A
Completed NCT02958475 - Mother's Milk Messaging: Evaluation of a Bilingual Application (APP) to Support Initiation and Exclusive Breastfeeding in New Mothers N/A
Active, not recruiting NCT05503069 - Community Interventions to Improve Breastfeeding N/A
Not yet recruiting NCT02233439 - Double-blind, Placebocontrolled A Randomized Trial on the Efficacy of Herbal Galactogogues N/A
Completed NCT01893736 - Professional Breastfeeding Support Intervention N/A
Completed NCT02738957 - Effect of Prenatal Counseling on Breastfeeding Rates in Twins N/A
Completed NCT00527956 - Facilitation and Barriers to Breastfeeding in the NICU N/A
Completed NCT03655314 - Using the Electronic Health Record to Guide Management of Newborn Weight Loss N/A
Completed NCT05562245 - Motivational Interviewing-Based Breastfeeding Education N/A
Completed NCT05106634 - Evaluation of Breastfeeding Success and Self-Efficacy in Mothers Giving Birth Via Vaginal Delivery or Cesarean Section
Completed NCT05992753 - Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
Recruiting NCT05250219 - Microchimeric Cell Tranfer From Mother to Child - Pilo Study
Recruiting NCT05213975 - Kinesio Taping Application After Cesarean Section N/A
Recruiting NCT05371106 - Mycotoxins in Mothers Milk in Israel
Completed NCT03332108 - Novel Approach To Improving Lactation Support With Mobile Health Technology N/A
Completed NCT02901665 - Impact of Increased Parent Presence in the Neonatal Intensive Care Unit on Parent & Infant Outcomes N/A