RINEW Randomized Controlled Trial 7-year Follow-up

NCT ID: NCT06802250

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-02-28

Brief Summary

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This study is designed to evaluate the impact of the RINEW multicomponent early child development intervention on child development and risk factors for poor child development in middle childhood. This study is a follow-up assessment of the children and primary caregivers enrolled in the RINEW cluster randomized controlled trial approximately 6 years following intervention completion.

Detailed Description

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Conditions

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Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessment team is separate from the implementation team, and are not aware of intervention components. Materials provided in the intervention (books, toys) may be visible in the participants homes, but the outcome assessment team was not aware that these are related to the intervention.

Study Groups

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Control arm

No intervention administered

Group Type NO_INTERVENTION

No interventions assigned to this group

Group only arm

Participants were encouraged to attend fortnightly courtyard group meetings

Group Type EXPERIMENTAL

RINEW intervention

Intervention Type BEHAVIORAL

The intervention included behavioral recommendations and guidance on the topics of Nutrition, WASH, Lead exposure prevention, Mental Health, and child stimulation. The intervention also included the provision of nutritional supplements based on age and nutritional status, low-cost picture books and toys, and soapy water bottles.

Combined delivery arm

Participants were visited by community health promoters once a month in their home as well as receive encouragement to attend monthly courtyard group meetings in between the monthly home visits.

Group Type EXPERIMENTAL

RINEW intervention

Intervention Type BEHAVIORAL

The intervention included behavioral recommendations and guidance on the topics of Nutrition, WASH, Lead exposure prevention, Mental Health, and child stimulation. The intervention also included the provision of nutritional supplements based on age and nutritional status, low-cost picture books and toys, and soapy water bottles.

Interventions

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RINEW intervention

The intervention included behavioral recommendations and guidance on the topics of Nutrition, WASH, Lead exposure prevention, Mental Health, and child stimulation. The intervention also included the provision of nutritional supplements based on age and nutritional status, low-cost picture books and toys, and soapy water bottles.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Child's primary caregiver was enrolled in the RINEW cluster randomized trial
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lia Fernald, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

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International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, , Bangladesh

Site Status RECRUITING

Countries

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Bangladesh

Central Contacts

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Lia Fernald, PhD

Role: CONTACT

(510) 643-9113

Facility Contacts

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Jesmin Sultana, MBBS

Role: primary

+88 02 2222 77 001-1 ext. 4028

Other Identifiers

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2024-02-17211

Identifier Type: -

Identifier Source: org_study_id

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