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Sleep Promotion Intervention in Bangladesh

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Columbia University

Status

Begins enrollment in a year or more

Conditions

Sleep

Treatments

Behavioral: Adapted Sleep Well, Bee Well (SWBW)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05763030
AAAU7943
1K01TW012425-01

Details and patient eligibility

About

Using a pragmatic cluster randomized trial, this study aims to examine the feasibility and acceptability of a 3-week behavioral sleep intervention and to test the preliminary efficacy of the intervention compared to a wait-list control with children ages 2-3 years old at two Early Learning Centers on preschooler's sleep health in Dhaka, Bangladesh.

The investigators will use novel, inexpensive wearable technology to measure sleep health of children at ages 2, 3, and 4 years in a total of 60 families of 2-3 year-old healthy children and teachers from both childcare centers. The program teaches early childhood educators about healthy sleep for young children and will train them to be confident facilitators of educational conversations about sleep with parents.

Parent questionnaires and sleep characteristics of children (actigraphy and parent report) will be collected at three-time points- Time 1, 2, and 3. Time 1 is the first Baseline Data Collection for the Control Group and Intervention Group, and these data will be collected before either group starts the 3-week intervention. Between Time 1 and Time 2, the Intervention Group will receive the 3-week intervention at the childcare center. Time 2 data collection for both groups will occur during the week following the completion of the intervention received by the Intervention Group. Time 2 data will serve as post-intervention data for the Intervention Group.

Full description

Poor sleep in children is a growing public health concern worldwide. Sleep health is a multidimensional construct (sleep-related behaviors, satisfaction, alertness, timing, efficiency, and duration) influenced by a complex interplay of social-ecological factors. Sleep impacts a range of physical health and neurodevelopmental outcomes including children's executive function (EF), growth, and obesity risk, which are public health priorities in low-and-middle-income countries (LMICs). Early EFs are predictive of social competence and academic performance and economic achievement in later life. Childhood obesity is a rapidly growing health issue in LMICs and a leading risk factor of diabetes. Interventions targeting modifiable sleep behavior have the potential to improve long-term physical and neurodevelopmental outcomes for millions of children in LMICs. Most data on children's sleep health are from high-income settings, and the recommendations based on these studies are not directly relevant to LMICs. Emerging evidence shows multiple cross-cultural differences in sleep dimensions in early childhood. Children in Asian countries have a significantly later bedtime and shorter sleep duration compared to children in Western countries. Recent research and our preliminary data suggest that 40% of preschool children in urban Bangladesh sleep less than the recommended duration (10-13 hours) by the World Health Organization (WHO). Evidence from high-income settings links individual (e.g., age, screen time, physical activity), interpersonal (e.g., maternal mood, parenting stress, mother-child interaction), and social (e.g., social socioeconomic condition, household crowding) factors to childhood sleep. We aim to study the determinants of sleep health using a socioecological framework, and the role of sleep health on growth and neurodevelopmental outcomes among 300 preschool children in Bangladesh, a lower-middle-income country in South Asia.

Enrollment

60 estimated patients

Sex

All

Ages

2 to 3 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy children aged 2-3 years
  • Attending early learning centers

Exclusion criteria

  • Diagnosed with cerebral palsy, severe developmental delay, cardiac disease, or autism
  • Known to be born preterm or low birth weight.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Intervention
Experimental group
Description:
Parent questionnaires and sleep characteristics of children (actigraphy and parent report) will be collected at three-time points- Time 1, 2, and 3. Time 1 is the first Baseline Data Collection for the Control Group and Intervention Group, and these data will be collected before the intervention group starts the 3-week intervention. Between Time 1 and Time 2, the Intervention Group will receive the 3-week intervention at the childcare center.
Treatment:
Behavioral: Adapted Sleep Well, Bee Well (SWBW)
Control
No Intervention group
Description:
The control arm will not receive the intervention. They will be assessed at time 1 and again at 2, following the completion of intervention in the intervention arm

Trial contacts and locations

1

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Central trial contact

Ayesha Sania, ScD; William P. Fifer, PhD

Data sourced from clinicaltrials.gov

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