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NCT Number: NCT05665049

Social Transfers for Exclusive Breastfeeding

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lao Tropical and Public Health Institute (Lao TPHI)

Vientiane, Laos

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social Transfer

Behavioral

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.

Primary outcomes

  1. Prevalence of Exclusive Breastfeeding at 6-Months Postpartum

    Time frame: 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.

Secondary outcomes

  1. Anthropometric Measurements

    Time frame: 1 month, 6 months, 1 year, 2 years, 3 years

    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.

  2. Mother and Child Anemia Levels

    Time frame: 1 month, 6 months, 1 year, 2 years, 3 years

    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.

  3. Early Childhood Development

    Time frame: 2 years

    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.

  4. Early Childhood Development

    Time frame: 3 years

    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.

  5. Complementary Breastfeeding Duration

    Time frame: 6 months, 1 year, 2 years

    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.

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • Lao Tropical and Public Health Institute
  • Swiss National Science Foundation
  • University of Basel

Registry information

Official study title

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

Acronym: STEB

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Dec 27, 2022
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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