Breast Feeding, ExclusiveSTEBNCT05665049
Social Transfers for Exclusive Breastfeeding
A study testing Social Transfer in people with Breast Feeding, Exclusive and Breastfeeding, run by Swiss Tropical & Public Health Institute at 1 site in Laos.
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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Exclusive, Breastfeeding, Development, Child
- What is being tested?
- Social Transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteLaos
- Study dates
- 1 Aug 2022to 30 Jun 2026
- Phase
- Interventional
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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Plans to move permanently outside study area
- Has a medical, intellectual or psychological disability
- Contraindication for breastfeeding
- Preterm births
- Children born with < 2500 grams
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- Are social transfers effective at increasing exclusive breastfeeding rates at 6-months
- Are social transfers cost-effective
- What are the long-term impacts of social transfers for breastfeeding on child development
Read more
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.
- Being tested
- Social Transfer
- Keywords
- breastfeeding, early childhood development, social transfer, cash transfer
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social TransferBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Only educational materials focused on the benefits of exclusive breastfeeding and the current international recommendations are provided. |
| Intervention Group 1 - Non-Conditional Social Transfer | Experimental | 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. Receives: Behavioral: Social Transfer |
| Intervention Group 2 - Conditional Social Transfer | Experimental | 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. Receives: Behavioral: Social Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months Postpartum
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start1 Aug 2022
- Primary completion30 Oct 2023
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Feeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Lao Tropical and Public Health Institute, University of Basel, Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Jordyn T Wallenborn, PhD, MPH, Principal investigator, Swiss Tropical and Public Health Institute, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665049
- Sponsor's protocol ID
- steb1
- Acronym
- STEB
- Status last verified
- Jan 2025
- First submitted
- 21 Oct 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wallenborn JT, Sonephet S, Sayasone S, Siengsounthone L, Kounnavong S, Fink G. Conditional and Unconditional Social Transfers, Early-Life Nutrition, and Child Growth: A Randomized Clinical Trial. JAMA Pediatr. 2025 Feb 1;179(2):129-136. doi: 10.1001/jamapediatrics.2024.5079.
PubMed 39680397Sonephet S, Kounnavong S, Zinsstag L, Vonaesch P, Sayasone S, Siengsounthone L, Odermatt P, Fink G, Wallenborn JT. Social Transfers for Exclusive Breastfeeding (STEB) Intervention in Lao People's Democratic Republic: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 May 3;13:e54768. doi: 10.2196/54768.
PubMed 38700928