NCT07541742

Brief Summary

This study aims to examine how societal and climate changes influence the nutritional status and fish consumption of young women over a 10 year period in southern Bangladesh, and how these factors affect their children's health. A cohort of 240 adolescents first studied in 2017 will be followed to assess changes in their dietary patterns, nutritional status, climate perceptions and mitigation practices, as well as the nutritional status of their children aged 6 months to 5 years. The study in 2017 sampled 60 adolescent girls in each of four rural communities, plus a semi-rural community around a fish processing plant, representing in total 5 communities. Of these 60 X 5 = 300 girls, the current study follows up the individuals in the rural communities representing a cohort of 240. Bangladesh faces high rates of adolescent malnutrition, with many girls married before 18 and suffering from chronic nutrient deficiencies. These issues have long-term impacts on health, productivity, and intergenerational well-being. By linking the fisheries and aquaculture sector, a key to Bangladesh's economy with public health and nutrition, this research aims to guide targeted policies for vulnerable coastal communities.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

March 27, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2026

Last Updated

May 6, 2026

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

March 27, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

Aquatic foodsadolescent nutritionfish intake assessmentdietary biomarkersclimate adaptationintergenerational nutritionBangladesh

Outcome Measures

Primary Outcomes (7)

  • Omega-3 status

    Eicosapentaenoic acid (EPA) in whole blood (% of total fatty acid)

    One sampling point between April and August 2026

  • Omega-3 status

    Docosahexaenoic acid (DHA) in whole blood (% of total fatty acid)

    One sampling point between April and August 2026

  • Micronutrient status

    Vitamin D (total 25-hydroxyvitamin D) concentration in blood, nmol/L

    One sampling point between April and August 2026

  • Micronutrient status

    Hemoglobin concentration in blood (g/dL)

    One sampling point between April and August 2026

  • Micronutrient status

    Ferritin concentration in blood (µg/L)

    One sampling point between April and August 2026

  • Inflammation status

    C-reactive protein concentration in blood (mg/L)

    One sampling point between April and August 2026

  • Inflammation status

    Alpha-1-acid glycoprotein concentration in blood (g/L)

    One sampling point between April and August 2026

Secondary Outcomes (6)

  • Nutritional status

    One measurement between April and August 2026

  • Nutritional status

    One measurement between April and August 2026

  • Nutritional status

    One measurement between April and August 2026

  • Nutritional status

    Between April and August 2026

  • Hair stable isotopes ratio

    Between April 2026 to August 2026

  • +1 more secondary outcomes

Other Outcomes (13)

  • Climate change perception and mitigation practice

    Between April and August 2026

  • Women empowerment

    Between April and August 2026

  • Dietary pattern, food frequency

    Between April 2026 to August 2026

  • +10 more other outcomes

Study Arms (1)

Follow-up of adolescent girls from 2017 to 2026

The cohort of adolescent girls enrolled in 2017 at ages 12-16 will be followed up in 2026 to assess changes in their socioeconomic status, nutritional status, dietary intake, and women empowerment, and to examine how these factors are associated with the nutritional status of their children aged 6 months-5 years.

Other: The follow-up aims to evaluate natural changes occurring from adolescence to young adulthood with respect to the study objectives due to lifestyle and environmental factors, without any intervention.

Interventions

Eligibility Criteria

Age5 Months - 27 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population is 240 young women who were studied as adolescents in 2017, now young women aged 22-26 years. If they have child aged 6 months to 5 years, the youngest child is included.

You may qualify if:

  • Young women aged 22-27 years who previously participated in the 2017 study. See study description.
  • If the women has a child age between 6 months to 5 years, the child child is included to be assessed

You may not qualify if:

  • Participants with serious health conditions that may interfere with study procedures or data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr, b)

Dhaka, Capital Region, 1000, Bangladesh

Location

Related Publications (2)

  • Ara, G., Little, DC, Mamun, AA, De Roos, B., Grieve, E., Khanam, M., ... & Roos, N. (2023). Factors affecting the micronutrient status of adolescent girls living in complex agro-aquatic ecological zones of Bangladesh. Scientific Reports , 13 (1), 6631.

    BACKGROUND
  • Grieve, E., Mamun, A. A., De Roos, B., Barman, B. K., Ara, G., Roos, N., ... & Little, D. C. (2023). Adolescent girls in aquaculture ecozones at risk of nutrient deficiency in Bangladesh development and validation of an integrated metric. BMC Public Health, 23(1), 405.

    BACKGROUND

Related Links

Central Study Contacts

Nanna Roos, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 21, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

August 5, 2026

Study Completion (Estimated)

December 10, 2026

Last Updated

May 6, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

According to the ethical approval, individual participant data cannot be shared with external parties and may only be obtained from the study coordinators upon reasonable request.

Locations