Sleep Promotion Intervention in Bangladesh

NCT ID: NCT05763030

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-04-30
• Study Completion Date: 2028-06-30

Brief Summary

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.

Detailed 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.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Adapted Sleep Well, Bee Well (SWBW)

Intervention Type: BEHAVIORAL

The SWBW is a 3-week multilevel behavioral sleep intervention that targets organizational (daycare worker-parent), interpersonal (parent-child, daycare worker-child), and individual (child) levels. It provides parent education supporting parent-child interaction at bedtime, helps to adopt a bedtime routine and early bedtime (Table 4). At the beginning of the 3-week intervention period, the parent and teacher co-develop tailored sleep health goals towards meeting the Bedtime, Environment, and Duration (BED) recommendations139-141 for the child. Parents receive an inexpensive bedtime kit, a storybook, and an informational brochure. The parent and child select four activities from the kit to perform at bedtime every night. The brochure has a section for the parents to write sleep goals. During the intervention, daycare teachers provide daily feedback support to parents at pick-up or drop-off. The program has a manualized structured curriculum suitable for use by paraprofessionals.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adapted Sleep Well, Bee Well (SWBW)

The SWBW is a 3-week multilevel behavioral sleep intervention that targets organizational (daycare worker-parent), interpersonal (parent-child, daycare worker-child), and individual (child) levels. It provides parent education supporting parent-child interaction at bedtime, helps to adopt a bedtime routine and early bedtime (Table 4). At the beginning of the 3-week intervention period, the parent and teacher co-develop tailored sleep health goals towards meeting the Bedtime, Environment, and Duration (BED) recommendations139-141 for the child. Parents receive an inexpensive bedtime kit, a storybook, and an informational brochure. The parent and child select four activities from the kit to perform at bedtime every night. The brochure has a section for the parents to write sleep goals. During the intervention, daycare teachers provide daily feedback support to parents at pick-up or drop-off. The program has a manualized structured curriculum suitable for use by paraprofessionals.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Ayesha Sania

Associate Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayesha Sania, ScD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

International Centre for Diarrhoeal Research, Bangladesh

Dhaka, , Bangladesh

Countries

Bangladesh

Central Contacts

Ayesha Sania, ScD

Role: CONTACT

as4823@cumc.columbia.edu

646-774-6242

William P. Fifer, PhD

Role: CONTACT

wpf1@cumc.columbia.edu

646-774-6248

Facility Contacts

Ayesha Sania, Sc.D.

Role: primary

as4823@cumc.columbia.edu

646-774-6242

Other Identifiers

1K01TW012425-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU7943

Identifier Type: -

Identifier Source: org_study_id