Improving Anemia Status of Female Garment Workers in Bangladesh: An Evaluation of Pilot Intervention in Four Factories

NCT03073590 | Completed

• 1 other identifier: PR-14113
• Study Type: interventional
• Target: 1,310
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is aimed at evaluating nutrition interventions to be implemented for improving health and nutritional status of female garments workers in 4 selected garment factories in Bangladesh. The interventions will attempt to increase either energy intake and or iron intake by female garments workers and expected to implement the interventions as planned:

• Prevalence of anemia
• Nutrition knowledge and practices as per key messages of the BCC program
• Worker satisfaction with the modified lunch and/or iron/folate supplementation, and the BCC program

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline Anemia level at 10 months

  Anemia will be assessed by measuring hemoglobin in capillary blood samples using portable HemoCue machine at baseline after enrolment and at the end of 10 months in female garment workers. Single finger prick method will be used to assess anemia status in field. The cut-off levels of haemoglobin that are considered to define anemia: \<110 g/L for pregnant and \<120 g/L for non-pregnant non-lactating or lactating women as the survey areas are at the sea level.

  up to 12 months

Study Arms (4)

Intervention with lunch

EXPERIMENTAL

Intervention factory with hot lunch program A. Nutritionally enhanced lunch meal program B. Once weekly iron/folate supplement C. Behavior change communications program

Combination Product: Intervention factory with hot lunch

Control with lunch

ACTIVE COMPARATOR

Control factory with lunch program A. Regular lunch meal program B. Behavior change communications program

Combination Product: Control factory with lunch program

Intervention without lunch

EXPERIMENTAL

Intervention factory without lunch program A. Twice weekly provision of iron/folate supplements B. Enhanced behavior change communications program

Combination Product: Intervention factory without lunch program

Control without lunch

ACTIVE COMPARATOR

Control factory without lunch program A. Behavior change communications program

Behavioral: Control factory without lunch program

Interventions

Intervention factory with hot lunch COMBINATION_PRODUCT

A nutritionally enhanced lunch meal program (increased dietary diversity plus inclusion of multi-nutrient fortified rice), provision of once weekly iron/folate supplement to female workers, and a BCC program conducted in the factory setting focused on improving health and nutrition for women and children, with a focus on anemia prevention.The BCC program will be enhanced to include modules on nutrition (balanced diets/dietary diversity, iron/folate rich foods), infant and young child nutrition (IYCN), and an overview module on anemia prevention, hand-washing with soap and dietary diversity at the very beginning of the intervention.

Intervention with lunch

Intervention factory without lunch program COMBINATION_PRODUCT

In a selected garment factory that does not have a lunch program, the intervention will consist of the twice weekly provision of iron/folate supplements to female workers, and the enhanced BCC program, as described above.

Intervention without lunch

Control factory with lunch program COMBINATION_PRODUCT

One control factory who provides regular lunch meal and a nutrition and health behavior change communications (BCC) program.

Also known as: Lunch factory control

Control with lunch

Control factory without lunch program BEHAVIORAL

One control factory was selected where only the standard Behavior change communication (BCC) was implemented.

Also known as: Non-lunch control

Control without lunch

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult Non-pregnant female garment worker between 18-42 years of age from selected factories who are present and give consent for interview

You may not qualify if:

• Eligible participants who decline consent
• Eligible participants suffering from any known chronic illnesses

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Icddr,B

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Muttaquina Hossain, MPH, MBBS

  Research Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To determine the impact of Hot lunch, iron -folate tablet and behaviour change communications program on the main outcome (i.e., prevalence of anemia) we used a quasi-experimental, controlled, pre-post design for both sets of interventions. Intervention Description Two types of interventions was tested against controls in a total of 4 factories. Among factories that already provide a hot lunch to workers, one intervention and one control factory was selected, and among factories that do not provide hot lunches, one intervention and one control factory was selected.

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: March 8, 2017
• Study Start: January 27, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: February 5, 2019

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)