Condition category
Nutritional, Metabolic, Endocrine
Date applied
31/10/2016
Date assigned
08/05/2017
Last edited
07/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
More than 200 million children under age 5 years are failing to reach their full potential of cognitive development (development of thinking, learning and memory skills). Traditional vertical programs typically only focus on only one area, such as maternal nutrition, child nutrition, water, sanitation, hygiene, community stimulation or reducing environmental lead exposure. Integrating these programs together however could be the most effective way of helping high risk mothers' to facilitate their childrens' development. The aim of this study is to develop a program which combines maternal nutrition, early childhood stimulation, water, sanitation, hygiene, infant and young child nutrition and lead exposure prevention delivered by local community promoters.

Who can participate?
Pregnant mothers and mothers of children under two years of age in select villages in Khishoreganj district (Bangladesh)

What does the study involve?
This study consists of two phases. In the development phase, community members who consent to participate are involved in group discussions, interviews, and participate in test versions of the main intervention in order to assess how feasible and acceptable it is. The resulting programme has four main components: water, hygiene and sanitation, nutrition, lead poisoning prevention and child stimulation. A different sample of community members who consent to participate are allocated to one of three groups. Those in the first group are encouraged to attend courtyard group meetings twice a month. Those in the second group receive a visit from community health promoters once a month in their home and are also encouraged to attend the monthly courtyard meetings in betwen their monthly home visits. The meetings/home visits are conducted by community health promoters and discuss the four intervention components. Those in the last group continue as normal and do not not attend any meetings or have home visits. Participants are followed up by community promoters at the beginning and end of the study to assess the feasibility, acceptability and uptake of this integrated interventions.

What are the possible benefits and risks of participating?
Participants may benefit from improved health. There are no notable risks with participating.

Where is the study run from?
The study is run from International Centre for Diarrhoeal Disease Research (Bangladesh) and takes place in villages in Khishoreganj district (Bangladesh)

When is the study starting and how long is it expected to run for?
July 2016 to August 2018

Who is funding the study?
Bill and Melinda Gates Foundation (USA)

Who is the main contact?
Professor Steve Luby

Trial website

Contact information

Type

Scientific

Primary contact

Prof Steve Luby

ORCID ID

http://orcid.org/0000-0001-5385-899X

Contact details

Stanford University
Y2E2
MC 4205
473 Via Ortega
Stanford
94305
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PR-16037

Study information

Scientific title

Piloting scalable nutritional, psychosocial and environmental interventions for child growth and development

Acronym

RINEW Pilot

Study hypothesis

The aim of this study is to develop and pilot an intervention package integrating maternal nutrition, early childhood stimulation, water, sanitation, hygiene, infant and young child nutrition and lead exposure prevention delivered by local community promoters.

Ethics approval

International Centre for Diarrhoeal Disease Research ICDDR, B Ethical Review Committee, 15/06/2016, ref: PR-16037

Study design

Stage one: Formative study
Stage two: Pilot community randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sub-optimal child development

Intervention

Formative Research stage:
This study includes an initial period of formative research on each of the intervention components to make sure that the interventions are evidence based, feasible and acceptable within the community. During this phase the integrated WASH, nutrition, lead poisoning and stimulation curriculum is developed. Community members are involved in focus group discussions, interviews, and participate in initial versions of group and home sessions to gather feedback and asses areas for improvement.

Pilot study:
Following the formative research phase, eligible community members who consent to participate are enrolled in the nine month pilot study, with interventions based on the initial formative research period. The interventions are conducted by community health promoters. This includes promoting maternal nutrition (i.e. promoting a diverse diet of nutrient-dense food), child nutrition (i.e. encouraging breastfeeding and high nutrient diets), increasing psychosocial stimulation (i.e. providing coaching to mothers on how to engage with their children), reducing lead exposure (i.e. teaching about pathways to exposure) and improving water, sanitation and hygiene (i.e. encourage handwashing, improving latrines, improving cooking methods).

Participants are randomly allocated to three different groups. Those in the first group (one-third of the mothers) are encouraged to attend fortnightly courtyard group meetings, those in the second group (one-third of the mothers) are 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. The last group act as the control group and they do not receive any intervention.

Mothers are visited at baseline and endline by study evaluators to assess the feasibility, acceptability and uptake of the integrated intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Feasibility and acceptability of the interventions as assessed by qualitative feedback from the study population and study implementers occurs continuously throughout the study (both formative stage and pilot intervention)
2. Adoption of behavior change recommendations as assessed by surveys (through use of the Family Care Indicators (FCIs) as well as additional items from the Home Observation Measurement of the Environment (HOME) scale), spot checks, and structured observations at baseline and endline of the pilot intervention.

Secondary outcome measures

Child development is measured using the Ages and Stages Questionnaire (ASQ) at baseline and endline of the pilot intervention.

Overall trial start date

01/07/2016

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant mothers and mothers of children <2 years of age in select villages in Khishoreganj district.

Participant type

All

Age group

Mixed

Gender

Both

Target number of participants

360

Participant exclusion criteria

Families planning to move.

Recruitment start date

01/06/2017

Recruitment end date

01/08/2017

Locations

Countries of recruitment

Bangladesh

Trial participating centre

International Centre for Diarrhoeal Disease Research
68, Shaheed Tajuddin Ahmed Sarani Mohakhali
Dhaka
1000
Bangladesh

Sponsor information

Organisation

Bill and Melinda Gates Foundation

Sponsor details

500 Fifth Avenue North
Seattle
98109
United States of America

Sponsor type

Charity

Website

www.gatesfoundation.org

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the outcomes of the study in one or more manuscripts in peer-reviewed journals within 24 months of conclusion of data collection.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes