Effect of Soaking Complementary Foods Flour on Hemoglobin Concentration, Anthropometric Deficits and Episode of Diarrheal, Cough and Fever Morbidities

NCT ID: NCT05254717

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-05-15

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.

Detailed Description

Objectives of the intervention

• To determine prevalence and associated factors of nutritional status and anemia among children aged 6-23 months in agrarian community of Bale zone
• To Explore the complementary feeding practice knowledge perception of mother with children aged 6-23 months in agrarian community of Bale zone
• To determine effect of soaking complementary foods flour on nutritional status of children aged 6-23 months in agrarian community of Bale Zone
• To determine effect of soaking complementary foods flour on hemoglobin level of children aged 6-23 months in agrarian community of Bale Zone
• To determine effect of soaking complementary foods flour on frequency of morbidity of children aged 6-23 months in agrarian community of Bale Zone

Target groups The target groups for the intervention will be mothers with their children aged 6-23 months in selected Districts of Bale zone and participated in the baseline study.

Following baseline study, the two districts were assigned to be either an intervention or comparison group randomly. While the intervention community received the Nutrition counselling on promotion of complementary flour soaking, the comparison community was monitored for presence of any other intervention that might have a potential to mask the effect of the current intervention in the target. The intervention will be carried out for a period of six months.

End-line data collection included the following major components:

• Dietary Diversity practice
• Anthropometric measurements
• Hemoglobin test

Conditions

Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Interventional arm

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

Group Type: EXPERIMENTAL

counselling

Intervention Type: OTHER

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

control arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

counselling

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• • If the child is seriously ill at the time of data collection

• Children with severe anemia hemoglobin level <= 7mg/dl will be excluded

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Madda walabu university

OTHER

Sponsor Role: lead

Responsible Party

Mekonnen Tegegne

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tefera Proff. Belachew, PHD

Role: STUDY_DIRECTOR

Dean of School of Graduate Studies, Jimma University

Locations

Jimma University

Jimma, Oromiya, Ethiopia

Countries

Ethiopia

References

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.

Reference Type: DERIVED

PMID: 39864523 (View on PubMed)

Other Identifiers

MWU

Identifier Type: -

Identifier Source: org_study_id