Enhancing Growth Monitoring Visits in Joshipur Rural Municipality, Kailai, Nepal

December 16, 2024 updated by: Amrita Ghimire, Kathmandu University School of Medical Sciences

Enhancing Growth Monitoring Visits Through Health Workers Training on Growth Monitoring and Promotion, GMP Guideline a Community Health Volunteer Mobilization for Increasing Demand of GMP Through GMP Day in Joshipur Rural Municipality, Kailai, Nepal

The goal of this clinical trial is to learn if health workers training on growth promotion and monitoring guideline and Female Community Health Volunteers mobilization for increasing demand for growth monitoring and promotion, GMP through growth monitoring and promotion day, GMP day) can enhance the growth monitoring and promotion practices in mothers and caretaker having under two years children. The main questions it aims to answer are:

  • Does health workers training on GMP guideline enhances the growth monitoring and promotion practices in mothers and caretakers having under two years children?
  • Does FCHV mobilization enhances growth monitoring and promotion practices in mothers and caretakers having under two years children? Participants will
  • Health workers of the Joshipur rural municipality will have to attend Training session on GMP guideline,
  • Mothers and caretakers having under two years children will have to visit to the nearest health facility for GMP visits for their children

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For addressing the problem of malnutrition in the municipality, determinants of the problem have been identified through CFIR framework. Based on the identified facilitator and barriers, two strategies have been developed for solving the problem of the municipality- (a) health workers training on latest GMP guideline to update the knowledge and skills of the service providers (b) For increasing demand generation, inviting mothers and caretakers having under two years children

  1. Health workers Training on GMP guideline: Mr. Ashish Timalsina will be responsible for one day training on GMP guideline to the health workers of all six health facilities who are primarily engaged in nutrition in Joshipur rural municipality.
  2. FCHV mobilization for increasing demand of growth monitoring and promotion through GMP day: Particular days of the month will be specified as GMP day in the municipality. Mothers and caretakers having under two years children. Health coordinator of the Joshipur rural municipality will be responsible for monitoring and supervision of this strategy.

Objectives General Objective

● To assess the implementation outcomes of Health workers Training on GMP guidelines and FCHV mobilization for increasing demand of Growth monitoring and Promotion through GMP day.

Specific Objectives

  • To assess acceptability, appropriateness, feasibility, fidelity of (a) Health workers Training on GMP guideline; and acceptability, appropriateness, feasibility of (b)FCHV mobilization for increasing demand of Growth monitoring and Promotion through GMP day by using PROCTOR's framework.

  • To assess the effectiveness of interventions- Health workers Training on GMP guideline and FCHV mobilization for increasing demand of Growth monitoring and Promotion through GMP day by average number of GMP visits.

    6. Methodology

Study site and its justification:

The study site will be Joshipur rural municipality, Kailali. There are seven wards in Joshipur Rural Municipality, in which a total of six health facilities are providing services in the Municipality. Average growth monitoring visit of the municipality was only 8 visits per child out of 24 visits per child (who have completed two years) in the fiscal year 2079/80 BS (2022 AD). The practice of growth monitoring was only 43% in the fiscal year 2079/80 BS (2022 AD). (HMIS)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Nepal
    • Far western
      • Joshipur, Far western, Nepal, 10909
        • Joshipur rural Municipality
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

For Health Workers:

  1. Nutrition focal person of the health facility having primary engagement in growth monitoring and promotion.
  2. Trained on growth monitoring and promotion guideline.

For Female Community Health Volunteers 1. Active for inviting mothers and caretakers of the municipality

For Mothers and caretakers having under two years children

1. Any mothers and caretakers having under two years children residing in Joshipur Rural Municipality during intervention.

Exclusion Criteria:

Who not available during the time of data collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health workers of Joshipur rural municipality and Female community health volunteers
Health workers will receive Training on GMP guideline, while FCHV will be mobilized for inviting mothers and caretakers having under two years children.
Other: Health workers training on GMP guideline
One day training will be conducted to health workers on updated GMP guideline for the health workers primarily engaged in Growth monitoring and promotion of the children.
Other: Female community health volunteers' mobilization for inviting mothers and caretakers
Female community health volunteers will be mobilized for inviting mothers and caretakers for two consecutive months for enhancing GMP practices in the municipality

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of Health Workers Training using key informant interview
Time Frame: At three months
Acceptability includes the attitude and perception of health workers regarding Health workers training and satisfaction level of health workers attending Health workers training on GMP guidelines. For which, a qualitative method (KII) with health workers using KII guideline will be employed for information collection among the health workers attending the health worker's Training
At three months
Appropriateness of Health workers Training using Key informant interview
Time Frame: At three months
Appropriateness is defined as Health workers training suitable for the cultural, social and economic context of Joshipur rural municipality and alignment of Health workers training to the needs and preferences of the health workers. For which, Key Informant Interview using KII guideline will be employed for information collection
At three months
Feasibility of Health workers Training
Time Frame: At three months
Feasibility includes practicality and ease of attending health workers training and availability of resources. For which information will be collected from health workers through Key Informant Interview using KII guideline.
At three months
Fidelity to GMP steps assed through observing HMIS register
Time Frame: At three months
Fidelity to GMP steps refers to evaluating the extent to which health workers adhere to the steps of GMP. It will be assessed by observing at the nutrition register by health workers as recoded of the steps conducted for growth monitoring and Promotion.
At three months
Acceptability of GMP day
Time Frame: At three months
Acceptability includes the attitude and perception of mothers and caretakers regarding Growth monitoring and Promotion Day . For which, qualitative method (Focus group discussion, FGD using FGD guideline, In-depth Interview, IDI using IDI guideline) will be employed for information collection.
At three months
Appropriateness of GMP day
Time Frame: At three months
Appropriateness includes the alignment of the Growth monitoring and Promotion Day with the needs and preferences of the target population. For which Qualitative method will be employed for information collection.
At three months
Feasibility of GMP day to health workers using key informant interview
Time Frame: At three months
Feasibility includes practicality and ease of implementing GMP day from health workers in the health facility which will be assessed using Key informant interview with health workers using KII guideline.
At three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kathmandu University School of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amrita Ghimire, MPH, Kathmandu University School of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GMP2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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