Social Transfers for Exclusive Breastfeeding (STEB)

Social Transfers for Exclusive Breastfeeding: A Pilot Program in Lao People's Democratic Republic (Lao PDR)

The goal of this study is to assess the effectiveness of social transfers on exclusive breastfeeding rates in Lao PDR. The main questions it aims to answer are:

1. Are social transfers effective at increasing exclusive breastfeeding rates at 6-months
2. Are social transfers cost-effective
3. What are the long-term impacts of social transfers for breastfeeding on child development

Participants will be randomly assigned to one of three groups: 1) control, no social transfer 2) non-conditional social transfer at 6-months postpartum, and 3) conditional social transfer at six months postpartum; conditional upon the mothers exclusive breastfeeding status.

All participants receive education about the benefits of exclusive breastfeeding and current international recommendations.

Researchers will compare the intervention groups to the control group to see if social transfers are effective at increasing exclusive breastfeeding rates at six months postpartum.

Study Overview

• Status: Active, not recruiting
• Conditions: Development, Infant; Breastfeeding; Development, Child; Breast Feeding, Exclusive
• Intervention / Treatment: Behavioral: Social Transfer

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordyn T Wallenborn, PhD, MPH; Phone Number: +41 76 525 0183; Email: jordyn.wallenborn@swisstph.ch

Study Locations

• Lao People's Democratic Republic
  • Vientiane, Lao People's Democratic Republic
    • Lao Tropical and Public Health Institute (Lao TPHI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Given birth in the last four weeks
• Exclusively breastfeeding at time of recruitment
• Lives in Vientiane in one of the following districts: Chanthabury, Sikhottabong, Sangthong, or Parkngum and is included in the VITERBI cohort

Exclusion criteria:

• Plans to move permanently outside study area
• Has a medical, intellectual or psychological disability
• Contraindication for breastfeeding
• Preterm births
• Children born with < 2500 grams

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Only educational materials focused on the benefits of exclusive breastfeeding and the current international recommendations are provided.
Experimental: Intervention Group 1 - Non-Conditional Social Transfer; Educational materials focused on the benefits of exclusive breastfeeding and the current international recommendations are provided. At the baseline visit, participants are told that at the 6-month visit, they will receive a gift of their choice - which is meant to show our appreciation and support for their efforts in breastfeeding.	Behavioral: Social Transfer; Social transfers are defined as a cash or in-kind transfer. Using results from a qualitative study, we identified the following culturally grounded social transfer options that is responsive to the identified needs of new mothers. Based on the monthly Lao PDR minimum wage and an estimated 15 full working days needed to exclusively breastfeed over a 6-month period, a social transfer of approximately $75 would fairly subsidize women's breastfeeding efforts. Therefore all social transfer options equate to approximately 75 USD. The options include: diapers, child developmental toys, cash, or a combination of these.
Experimental: Intervention Group 2 - Conditional Social Transfer; Educational materials focused on the benefits of exclusive breastfeeding and the current international recommendations are provided. At the baseline visit, participants are told that at the 6-month visit, they will receive a gift of their choice if they are still exclusively breastfeeding.	Behavioral: Social Transfer; Social transfers are defined as a cash or in-kind transfer. Using results from a qualitative study, we identified the following culturally grounded social transfer options that is responsive to the identified needs of new mothers. Based on the monthly Lao PDR minimum wage and an estimated 15 full working days needed to exclusively breastfeed over a 6-month period, a social transfer of approximately $75 would fairly subsidize women's breastfeeding efforts. Therefore all social transfer options equate to approximately 75 USD. The options include: diapers, child developmental toys, cash, or a combination of these.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Exclusive Breastfeeding at 6-Months Postpartum	The primary endpoint is the proportion of women exclusively breastfeeding at 6-months postpartum assessed using a questionnaire. Exclusive breastfeeding is defined as receipt of only human milk - which is consistent with the World Health Organization guidelines. At six months postpartum, mothers are asked if they are still currently breastfeeding. If they answer yes, a follow-up question on if they provided any other liquids, solids, or supplements to their child to determine the exclusive breastfeeding status.	6 Months Postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric Measurements	Infants will be measured for length, weight, head circumference, skinfold thickness. Height was measured in centimeters by using a Height Measuring Device, stadiometer, 20-205cm. Weight was measured in kilograms by a mobile weighing scale. Skin fold measurements were collected using a skin fold caliper. Head, waist, and hip measurements and MUAC were measured using non-stretchable measuring tape. All measurements will be analyzed as age standardized z-scores.	1 month, 6 months, 1 year, 2 years, 3 years
Mother and Child Anemia Levels	We will assess the mother and child anemia levels. The HemoCue Hb 301 will be used to give an instant measurement of the Haemoglobin (Hb) level of the patient. Capillary blood will be collected through a finger prick. Blood samples drawn for the haemoglobin assessment will be discarded after the test. Iron levels will be analyzed as a continuous outcome.	1 month, 6 months, 1 year, 2 years, 3 years
Early Childhood Development	When the child is two years of age, a comprehensive end line assessment will be conducted to evaluate early childhood development indicators (e.g. The Global Scale for Early Development (GSED). This indicator will be normalized to a mean of 0 and SD of 1 to facilitate interpretation of estimated group differences.	2 years
Early Childhood Development	When the child is three years of age, the IDELA will assess children's cognitive, social and language skills, and lifelong capacity for learning. This indicator will be normalized to a mean of 0 and SD of 1 to facilitate interpretation of estimated group differences.	3 years
Complementary Breastfeeding Duration	The proportion of women complementary breastfeeding at 6-months, 1-year, and 2-years postpartum assessed using a questionnaire. Complementary breastfeeding is defined as receipt of human milk in combination with complementary foods and liquid. At each time point postpartum, mothers are asked if they are still currently breastfeeding. If they answer yes, a follow-up question on if they provided any other liquids, solids, or supplements to their child to determine the complementary breastfeeding status.	6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Swiss National Science Foundation; University of Basel; Lao Tropical and Public Health Institute (Lao TPHI)
• Investigators: Principal Investigator: Jordyn T Wallenborn, PhD, MPH, Swiss Tropical and Public Health Institute, University of Basel

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 30, 2023
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: breastfeeding; early childhood development; social transfer; cash transfer
• Other Study ID Numbers: steb1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No