Homemade Yogurt Supplementation to Prevent Stunting

NCT ID: NCT04067284

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-03-31

Brief Summary

Stunting contributes substantially to child mortality and disease burden in low-income countries. In Bangladesh the prevalence of stunting among children <5-years of age is high (36%) reaching 50% in slum areas. The pathogenesis of stunting is multifaceted, yet nutritional inadequacy and repeated infections are established risk factors of stunting.

A three-arm randomized controlled trial in Dhaka's slum area is proposed. The children will be recruited from vaccination clinics. Infants at risk of stunting (-1 SD length-for-age z-score, LAZ) aged around 5 months are eligible for the study. Eligible children will be randomized to receive: 1) nutrition education on dietary diversity; 2) a combination of similar education plus daily supplementation of homemade yogurt; 3) a 'usual care' (control) group. The investigators will recruit 120 children (40 per arm). Intervention will be initiated a month before starting of complementary feeding with an educational session and will last 7 months during which a monthly educational session will be delivered at participant's household. The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding. Feeding behaviors will be self-monitored using a pictorial calendar. Primary outcome (LAZ) and secondary outcomes (fecal bio-markers, WAZ, head circumference, and food diversity scores), will be measured at baseline (6 months), 9 months and 12 months of child age. Supplementation with homemade yogurt is a novel approach with the potential to improve infant gut environment, improve food absorption and thus potentially prevent stunting.

Detailed Description

Hypothesis:

The investigators hypothesize that, continued breastfeeding, adequate complimentary feeding and supplementation with homemade yogurt have the potential to reduce stunting.

Primary objective:

The present study is aimed to assess the impact of low-cost nutritional strategies to prevent childhood malnutrition in Bangladesh.

Specific objectives:

1. To compare differences in growth pattern (length-for-age z-score, weight-for age z-score, head circumference) of children at risk of stunting age 6-months between infants receiving educational program only, infants receiving education plus homemade yogurt supplementation and those receiving the "usual-care" (control).

2. To evaluate whether amount of gut microbiota necessary to improve gut health was associated with weight gain and growth in these children to support the casual mechanism behind this approach.

Conditions

Child Malnutrition

Study Design

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

Study Groups

Education

Nutrition education on dietary diversity.

Group Type: ACTIVE_COMPARATOR

Nutrition education

Intervention Type: BEHAVIORAL

Nutrition Education on

• Continued breastfeeding until two years of age
• Food groups
• Balanced diet
• Introduction to locally available nutritious and low-cost foods
• Amount and frequency of complementary feeding
• Safe water, and
• Handwashing with soap before feeding

Yogurt

A combination of similar education plus daily supplementation of homemade yogurt

Group Type: EXPERIMENTAL

Homemade yogurt supplementation

Intervention Type: DIETARY_SUPPLEMENT

The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding.

Control

Control group.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

No intervention/ control group

Interventions

Nutrition education

Nutrition Education on

• Continued breastfeeding until two years of age
• Food groups
• Balanced diet
• Introduction to locally available nutritious and low-cost foods
• Amount and frequency of complementary feeding
• Safe water, and
• Handwashing with soap before feeding

Intervention Type: BEHAVIORAL

Homemade yogurt supplementation

The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding.

Intervention Type: DIETARY_SUPPLEMENT

Usual care

No intervention/ control group

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Infants at risk of developing stunting aged 5 months (-1SD LAZ)

2. All gender, religion, language and ethnicity

3. Infants born through normal delivery or cesarean section

4. Breastfeeding or non-breastfeeding

Exclusion Criteria

1. Stunting or wasting (<-2SD LAZ)

2. Infants with any major congenital abnormality or any chronic conditions (e.g., rheumatic heart disease)

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Western Sydney

OTHER

Sponsor Role: collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dr. Mahbubur Rahman

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

PR-19062

Identifier Type: -

Identifier Source: org_study_id