NCT03824756

Brief Summary

Background: To tackle the high burden of undernutrition, the government of Bangladesh has identified growth monitoring and promotion (GMP) as a priority activity in the National Nutrition Services operational plan. Till date, no evidence are available from Bangladeshi studies to identify the effectiveness of GMP in improving the nutritional status of Bangladeshi children under 2 years of age. During 2013-14, two Bangladeshi studies looking at implementation issues of GMP at Community Clinic level and assessing the quality of nutrition services at primary health care facilities. The studies identified that lack of coordination, inadequate training, supervision, and logistic supplies as challenges to GMP implementation. Currently, GMP, (primarily sick child GMP) is being implemented through community clinics, supported by non-governmental organizations (NGOs) or other programs funded by donors. Besides, GMP is also taking place in areas where there are no NGO or donor support activities. However, the quality of nutrition data related to GMP is believed to be unsatisfactory. Hence, it is important to assess the effectiveness of GMP on the growth of under 2-year-old children. Hypothesis: GMP services could improve the growth of children under 2 years of age by 20 percent in the intervention group compared to the control group Objectives:To examine the effectiveness of GMP in improving nutritional status of children under 2 years of age Methods: Study design: Quasi-experimental study using mixed methods Study duration: 24 months Study setting: The study will be conducted in six sub-districts of rural Bangladesh where GMP is operational at the community clinic level. However, those areas will be excluded if there is any ongoing community or household level intervention on nutrition counseling being implemented by an NGO. For smooth implementation of GMP, refresher training on nutrition to health service providers will be provided by the study team. Study participants: children under 2 years of age, mother's/caregiver's of children \<2 and service providers. Intervention group: children under 2 years of age who are exposed to GMP services at community clinics where an NGO funded program is supporting GMP implementation Control group: children under 2 years of age, at community clinics where GMP is not operational

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
3.4 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 31, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

January 17, 2019

Last Update Submit

March 30, 2022

Conditions

Keywords

Growth monitoring and promotionchild growthInfant and young child feeding practicesprogramBangladesh

Outcome Measures

Primary Outcomes (2)

  • Change in length of the children under 2 years of age

    Children who are aged between 6-12 months, their length in centimeter will be measured at baseline and then 3 monthly till end-line using a standard length board. The length for age z-score will be calculated by using a software developed by World Health Organization. The changes in length for age z-score will be detected through comparing the measurements over time by using difference-in-difference method.

    12 months

  • Change in weight of the children under 2 years of age

    Children who are aged between 6-12 months, their weight in kilograms will be measured at baseline and then 3 monthly till end-line using a standard weighing scale. The weight for age z-score will be calculated by using a software developed by World Health Organization. The changes in weight for age z-score will be detected through comparing the measurements over time by using difference-in-difference method.

    12 months

Secondary Outcomes (2)

  • Change in mother's knowledge and attitude on infant and young child feeding (IYCF) practices measured by a standard semi-structured questionnaire

    12 months

  • Changes in service provider's skill and perception on GMP

    12 months

Study Arms (2)

NGO supported GMP program

EXPERIMENTAL

Intervention: NGO supported GMP program Site: Community clinic Duration: 12 months Study participants: 6-12 months aged children living within community clinic catchment area

Other: NGO supported GMP program

Non-supported GMP program

ACTIVE COMPARATOR

Comparison: Non-supported GMP program Site: Community clinic Duration: 12 months Study participants: 6-12 months aged children living within community clinic catchment area

Other: Non-supported GMP program

Interventions

An International NGO has signed a contract with Government to support in implementing the growth Monitoring and Promotion (GMP) program. This program will be implemented at Community clinics. It will ensure the sustainability of community clinics in the selected areas through capacity building and follow up with community groups, community support groups, and Government Health and Family Planning service providers.

Also known as: Intervention arm
NGO supported GMP program

This is control arm of the study. In this arm, there will be Government's usual GMP program implemented at community clinics without any NGO support.

Also known as: Control arm
Non-supported GMP program

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 6-12 months living in community clinic catchment area
  • Free from any acute or chronic illness(es)
  • Not a known case of a congenital anomaly or chromosomal abnormality
  • Not severely stunted (length-for-age Z score, LAZ \<-3) or wasted (weight-for-length Z score, WLZ \<-3) or underweight (weight-for-age Z score, WAZ \<-3)
  • Not enrolled in any other intervention program
  • Caregiver report to have no plans to move out of the catchment area for at least 6 months following enrolment in the study

You may not qualify if:

  • Children's parents who will decline consent will not be enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hossain M, Ferdous TE, Islam Z, Billah SM, Bulbul MMI, Rahman MM, Ahmed T. Protocol for a quasiexperimental study testing the effectiveness of strengthening growth monitoring and promotion in community clinics for improving the nutritional status of under-two children in rural Bangladesh. BMJ Open. 2019 Oct 10;9(10):e032458. doi: 10.1136/bmjopen-2019-032458.

Study Officials

  • Muttaquina Hossain, MPH

    Assistant Scientist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muttaquina Hossain, MPH

CONTACT

Tahmeed Ahmed, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 31, 2019

Study Start

July 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

March 31, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

The privacy, anonymity, and confidentiality of data/information identifying the study participants will be strictly maintained. Personal identifications taken during the survey will be kept under lock and key. None other than the study personnel will have access to information on personal identification and other sensitive information.