Social Transfers for Exclusive Breastfeeding

Breastfeeding Clinical Trial

— STEB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05665049
• Other study ID #: steb1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2027
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Feeding, Exclusive
• Breastfeeding
• Development, Child
• Development, Infant

Intervention

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.

Locations

Country	Name	City	State
Lao People's Democratic Republic	Lao Tropical and Public Health Institute (Lao TPHI)	Vientiane

Sponsors (4)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Lao Tropical and Public Health Institute (Lao TPHI), Swiss National Science Foundation, University of Basel

Country where clinical trial is conducted

Lao People's Democratic Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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