NCT05254717

Brief Summary

Removing anti nutrient factors using simple cost-effective and sustainable household methods to improve nutritional status of children in communities were plant based complementary foods are the main source of Nutrients is highly recommended. Therefore, the aim of this study is to determine effect of soaking complementary foods on hemoglobin, nutritional and health status of children 6-23 months in agrarian community of bale zone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

6 months

First QC Date

February 2, 2022

Last Update Submit

September 13, 2022

Conditions

Keywords

Complementary feedingsoaking FloursUndernutritionAnemia

Outcome Measures

Primary Outcomes (3)

  • children's blood hemoglobin concentration level

    15 days post intervention

  • children's Anthropometric deficits; Wasting (low-weight-for-length), stunting (low-Length-for-age) and underweight (low-weight-for-age)

    15 days post intervention

  • children's Episode of Diarrheal, cough and fever Morbidities

    15 days post intervention

Study Arms (2)

Interventional arm

EXPERIMENTAL

Following baseline study, the interventional arm assigned to receive counselling intervention on complementary food flour soaking

Other: counselling

control arm

NO INTERVENTION

The control group will be monitored for presence of any other intervention that might have a potential to mask the effect of the current intervention.

Interventions

intervention groups will receive counselling on improving quality of complementary feeding by soaking complementary foods flours and basic methods of soaking complementary flours.

Interventional arm

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Voluntarily agreed mothers with children aged 6-23 month
  • Mothers with children aged 6-23 month who lived at least six months in the selected communities
  • Mothers who have no plan to leave the area within 6 months period

You may not qualify if:

  • If the child is seriously ill at the time of data collection
  • Children with severe anemia hemoglobin level \<= 7mg/dl will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jimma University

Jimma, Oromiya, 378, Ethiopia

Location

Related Publications (1)

  • Tegegne M, Abate KH, Belechew T. Effect of counselling about complementary food flour soaking on nutritional and health status of children 6-23 months, a quasi-experimental study. Clin Nutr ESPEN. 2025 Apr;66:281-289. doi: 10.1016/j.clnesp.2025.01.038. Epub 2025 Jan 27.

MeSH Terms

Conditions

AnemiaMalnutrition

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Tefera Proff. Belachew, PHD

    Dean of School of Graduate Studies, Jimma University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 24, 2022

Study Start

November 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 15, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations