NCT05665049

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Aug 2022Dec 2027

Study Start

First participant enrolled

August 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

October 21, 2022

Last Update Submit

January 9, 2025

Conditions

Keywords

breastfeedingearly childhood developmentsocial transfercash transfer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Anthropometric Measurements

    1 month, 6 months, 1 year, 2 years, 3 years

  • Mother and Child Anemia Levels

    1 month, 6 months, 1 year, 2 years, 3 years

  • Early Childhood Development

    2 years

  • Early Childhood Development

    3 years

  • Complementary Breastfeeding Duration

    6 months, 1 year, 2 years

Study Arms (3)

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.

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.

Behavioral: Social Transfer

Interventions

Social TransferBEHAVIORAL

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.

Intervention Group 1 - Non-Conditional Social TransferIntervention Group 2 - Conditional Social Transfer

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lao Tropical and Public Health Institute (Lao TPHI)

Vientiane, Laos

Location

Related Publications (2)

  • 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.

  • Sonephet 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.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Jordyn T Wallenborn, PhD, MPH

    Swiss Tropical and Public Health Institute, University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2022

First Posted

December 27, 2022

Study Start

August 1, 2022

Primary Completion

October 30, 2023

Study Completion (Estimated)

December 31, 2027

Last Updated

January 13, 2025

Record last verified: 2025-01

Locations