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Nutritional StatusGMPNCT03824756

Assessing the Effectiveness of Strengthening the Growth Monitoring and Promotional Activities in Rural Bangladesh

A study testing NGO supported GMP program and Non-supported GMP program in people with Nutritional Status, run by International Centre for Diarrhoeal Disease Research, Bangladesh.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 monthsHealthy volunteers can take part
Conditions the study is for
Nutritional Status
What is being tested?
NGO supported GMP program and Non-supported GMP program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
No sites listed yet
Study dates
1 Jul 2022to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Muttaquina Hossain, MPH contact

02-01923758956

muttaquina@icddrb.org

Tahmeed Ahmed, PhD contact

02-01713044799

tahmeed@icddrb.org

About this study

Official title: Assessing the Effectiveness of Strengthening the Growth Monitoring and Promotional Activities in Improving the Nutritional Status of Children Under 2 Years of Age in Rural Bangladesh

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

Read more

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

Read the detailed description

Introduction and objective:

Bangladesh has partly achieved the millennium development goal targets for nutrition and is committed to achieving the Sustainable development goals targets. Between 1997 and 2014, childhood stunting reduced from 60% to 36% nationally, and wasting has declined from 21% to 14%. However, 6.4 million children remain stunted, leaving them unable to develop to their full physical and mental potential. To tackle the high burden of under-nutrition, the government of Bangladesh has identified growth monitoring and promotion (GMP) as a priority activity in the National Nutrition Services operational plan. GMP is to be implemented from all primary health care facilities of the government health system. Growth Monitoring and Promotion (GMP) is a preventive activity comprised of growth monitoring linked with promotion (usually counseling) that increases awareness about child growth and improves caring practices. Ideally, in GMP, the weight of children usually under 2 years of age is measured periodically (for example, on a monthly or bi-monthly basis). The measurement can start at birth, accurately recorded on a growth chart, interpreted and explained to the caregivers. Additionally, the health workers give information through counseling, facilitating communication, and interacting with mothers in a way that aims to generate adequate maternal action to promote child growth. Recent systematic reviews question the effectiveness and relevance of GMP programs in general. Currently, GMP, which is primarily focused on sick child GMP is being implemented through community clinics (CCs), supported by NGOs or other programs funded by donors. Besides, GMP is also taking place in areas where there are no non-governmental organization (NGO) or donor support activities. However, the quality of nutrition data related to GMP is believed to be unsatisfactory. On this backdrop, it is important to assess the GMP implementation and its effect on the growth of under 2-year-old children. Hence, this study will offer a useful opportunity to examine the effectiveness of strengthening the GMP activities in improving growth and infant and young child feeding (IYCF) practices among children under 2 years of age in rural Bangladesh.

Selection of study site:

From the discussion and list of sub-districts shared by the NGO program, the investigators have selected 3 sub-districts where the program will be implemented from January 2018. The investigators have selected these 3 sub-districts based on (a) time of implementation of the program which matches with the project timeline; (b) available staff and logistics support by the NGO program in these sub-districts; and (c) large number of Community Clinics in these sub-districts to satisfy the required number of study participants and their caregivers. Additionally, the investigators have also selected 3 sub-districts as control keeping an adequate buffer zone to avoid intervention spill-over effect. The investigators will select 30 community clinics from these sub-districts through a community scoring system to have the maximum impact of the program.

Selection of study participants: The community clinics (CCs) and its catchment area will be considered as clusters. From the list of community clinics, required numbers of clusters will be randomly selected through a proportionate sampling. From the randomly selected CCs, the required number of study participants will be enrolled after conducting household listing.

Data collection procedures: The children will be enrolled from the catchment area of community clinics and be followed up for 12 months. During the follow-up period, the children will be visited periodically to assess their exposure to GMP service and also their feeding practice. Anthropometric measurements will be taken at baseline and then tri-monthly till the end of the 12 months follow-up period. Mother's knowledge and attitude about IYCF issues will be assessed at baseline and at an endpoint survey. Service provider's skills and perception about GMP will be assessed at baseline and at end-line. Quality of GMP implementation will be at baseline and periodically during the follow-up period.

Data collection tools: Household surveys, key informant interviews (KII), and observation.

Data analysis The survey data will be analyzed using STATA software (version 13). The summary statistics would be expressed as means with standard deviations, medians or percentages, with 95% confidence intervals (CI) where appropriate. To assess differences in mean among the factories, ANOVA and for categorical outcomes, chi-square statistical comparisons of proportions with 95% confidence intervals, will be calculated. A difference-of-difference (DID) analysis of quantitative outcome data will be done. To identify significant predictors associated with the main outcome indicators, bi-variate and multiple regression analyses will be employed.

Thematic analysis will be followed for qualitative information collected through participant's caregiver interview, key informant interview, and observation. Following preparation of the transcript, responses will be coded according to themes (a priori), sub-themes and emergent issues, if any. Triangulation of data derived from different methods will be carried out to validate qualitative information.

Being tested
NGO supported GMP program, Non-supported GMP program
Keywords
Growth monitoring and promotion, child growth, Infant and young child feeding practices, program, Bangladesh

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NGO supported GMP programOther

    Also called Intervention arm

    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.

  • Non-supported GMP programOther

    Also called Control arm

    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.

Study groups in NCT03824756
Study groupRoleWhat they receive
NGO supported GMP programExperimentalIntervention: NGO supported GMP program Site: Community clinic Duration: 12 months Study participants: 6-12 months aged children living within community clinic catchment area
Receives: Other: NGO supported GMP program
Non-supported GMP programActive comparatorComparison: Non-supported GMP program Site: Community clinic Duration: 12 months Study participants: 6-12 months aged children living within community clinic catchment area
Receives: Other: Non-supported GMP program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

Secondary outcomes (2)
  1. Change in mother's knowledge and attitude on infant and young child feeding (IYCF) practices measured by a standard semi-structured questionnaire

    The change in IYCF practice will be reported in percentages through baseline and end-line differences through following indicators (either combined or separately):

    1. Early initiation of breastfeeding
    2. Introduction of solid, semi-solid or soft foods
    3. Minimum dietary diversity
    4. Minimum meal frequency
    5. Minimum acceptable diet: It summed the results of Minimum dietary diversity and Minimum meal frequency.

    Measured: 12 months

  2. Changes in service provider's skill and perception on GMP

    The community clinic service provider's skill and perception on GMP will be measured by using observation checklist and key informant interviews at baseline and end-line. The responses gathered from this 2 time points will be compared at the end of the study.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2019
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03824756
Sponsor's protocol ID
PR-17123
Acronym
GMP
Status last verified
Feb 2022
First submitted
17 Jan 2019
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 31601604

Questions about this trial

What is this clinical trial studying?

A study testing NGO supported GMP program and Non-supported GMP program in people with Nutritional Status, run by International Centre for Diarrhoeal Disease Research, Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Muttaquina Hossain, MPH (02-01923758956, muttaquina@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in length of the children under 2 years of age (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03824756, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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