NCT04758169

Brief Summary

Child marriage leads to pregnancy in adolescence, a root cause of both malnutrition and the intergenerational cycle of malnutrition. Two-thirds of Bangladeshi girls are married before 18 years, nearly half become pregnant before 19, and the rates of stunting and underweight are 26% and 36%, respectively. There are well-established risks of adolescent pregnancy for both mother (impaired growth and development due to nutrient reallocation for pregnancy and lactation), and infants (increased risk of low birth weight and small-for-gestational-age). Poor sexual and reproductive health (SRH), infant and young child feeding (IYCF), and water, sanitation, and hygiene (WASH) knowledge could impair the nutritional and health status of the whole family, sparking intergenerational issues. The investigators propose to investigate the efficacy of a gender-transformative enhanced homestead food production (EHFP) program to prevent child marriage, and in turn, adolescent pregnancy-induced malnutrition among girls aged 13-15 years in a high-risk area for child marriage, Khulna Division, southern Bangladesh. The investigators will conduct a cluster-randomized controlled trial in which n=1200 girls in after-school Adolescent Clubs will participate in a 24-month program teaching women's empowerment through hands-on workshops. All participants (control and EHFP groups) will be exposed to SRH, WASH, and IYCF, while those in the EHFP group will also receive EFHP training and inputs intended to improve nutrient intake and provide an income source for the adolescent girls' family. Investigators hypothesize that girls in the EHFP group will have lower rates of marriage and pregnancy, and improved food security, dietary diversity, nutritional status, IYCF, WASH, and SRH knowledge/practices.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

February 10, 2021

Last Update Submit

August 24, 2021

Conditions

Adolescent BehaviorHealth BehaviorMarriage Age

Keywords

Homestead Food ProductionSexual and Reproductive HealthDietary DiversityHousehold Food Security

Outcome Measures

Primary Outcomes (4)

  • Prevalence of child marriage

    This is a continuous variable and the goal is to delay the marriage of the adolescent girl until after 16th birthday.

    Baseline to twenty four months of the intervention

  • Adolescent nutrition status-Anemia

    Anemia will be measured by hemoglobin concentration in the blood and, for this particular indicator, will be collected among adolescent girls (13-15 years). Non-pregnant adolescent girls with a hemoglobin concentration less than 12g/dl will be classified as anemic. The numerator for this indicator is the sample-weighted number of anemic adolescent girls 13-15 years in the sample. The denominator is the sample-weighted number of adolescent girls 13-15 years in the sample with hemoglobin data.

    Baseline to twenty four months of the intervention

  • Household income

    Monthly household income will be measured in US$ by observing changes from baseline to endline

    Baseline to twenty four months of the intervention

  • Adolescent nutrition status-Underweight

    BMI is an anthropometric index of weight and height that is defined as body weight in kilograms divided by height in meters squared. BMI is used to assess underweight status of adult and adolescents.

    Baseline to twenty four months of the intervention

Secondary Outcomes (3)

  • Food security status of the household

    Through study completion, an average of 4 months

  • Adolescent empowerment and participation in household decision-making

    Through study completion, an average of 4 months

  • Adolescent nutrition status-Dietary diversity

    Through study completion, an average of 4 months

Study Arms (2)

Enhanced Homestead Food Production

EXPERIMENTAL

Participant in this arm will receive the Helen Keller's EHFP model which involves homestead food production, nutrition and WASH education and gender transformative sessions (intervention group). Participants will also receive interventions related to parental awareness sessions, community awareness-raising activities, adolescent group sessions involving awareness on the benefit of delayed marriage and empowerment, SRH and basic life-skill trainings.

Other: Enhanced Homestead Food Production

Control

EXPERIMENTAL

Participants in this arm will only receive parental awareness sessions, community awareness-raising activities, adolescent group sessions involving awareness on the benefit of delayed marriage and empowerment, SRH, and basic life-skill trainings. This particular arm will not receive any homestead food production intervention over the course of the implementation.

Other: Control

Interventions

Enhanced Homestead Food ProductionOTHER

Enhanced Homestead Food Production program will provide increased production and consumption of nutrient rich foods, increased income of the households through the sale of surplus produce, and increased self-efficacy and decision making by adolescents due to increased knowledge and skills- resulting increased food security and nutrition and ultimately delay of child marriage.

Enhanced Homestead Food Production
ControlOTHER

Control group will only receive parental awareness sessions, community awareness-raising activities, adolescent group sessions involving awareness on the benefit of delayed marriage and empowerment, SRH, and basic life-skill trainings.

Control

Eligibility Criteria

Age13 Years - 15 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdolescent girls age between 13 to 15 years
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Not be married,
  • Are not sick
  • Have never been pregnant,
  • Be aged 13-15 years,
  • Be willing to attend monthly workshops at their local Adolescent Club,
  • Provide written assent to participate from adolescent, and have their primary caregiver (e.g. father/mother) provide written consent for participation,
  • Have access to a minimum of about 60 sq.m (1.5 decimal) of homestead land available for EHFP activities at their home.

You may not qualify if:

  • Not ill or in unhealthy condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen Keller International

Sātkhira, Khulna Division, 9430, Bangladesh

Location

Related Publications (22)

  • Helen Keller International (HKI), James P Grant School of Public Health (JPGSPH). State of Food Security and Nutrition in Bangladesh: 2013. Dhaka; 2014.

    BACKGROUND

  • BDHS. Bangladesh Demographic and Health Survey 2014. 2014. 1-354 p.

    BACKGROUND

  • Ainul S, Bajrachrya A, Reichenbach L. Adolescents in Bangladesh: A Situation Analysis of Programmatic Approaches to Sexual and Reproductive Health Education and Services. Popul Counc Evid Proj. 2017;(January):62.

    BACKGROUND

  • NIPORT. Bangladesh Demographic Health Survey 2007. Natl Inst Popul Res Train. 2007;1-381.

    BACKGROUND

  • NIPORT. Bangladesh Demographic and Health Survey 2014. Dhaka, Bangladesh, and Rockville, Maryland, USA. 2015.

    BACKGROUND

  • Dixon-Mueller R. How young is "too young"? Comparative perspectives on adolescent sexual, marital, and reproductive transitions. Stud Fam Plann. 2008 Dec;39(4):247-62. doi: 10.1111/j.1728-4465.2008.00173.x.

    PMID: 19248713BACKGROUND

  • Dick B, Ferguson BJ. Health for the world's adolescents: a second chance in the second decade. J Adolesc Health. 2015 Jan;56(1):3-6. doi: 10.1016/j.jadohealth.2014.10.260.

    PMID: 25530601BACKGROUND

  • MoWCA. কিশোর-কিশোরী ক্লাব - Adolescent Program of Bangladesh [Internet]. 2017. Available from: https://mowca.gov.bd/site/notices/f64412aa-e606-47ae-ab7c-63848d74f8ec/Kishore-Kishori-club-project-review-meeting

    BACKGROUND

  • Amin S, Ahmed J, Saha J, Eashita H, Haque F. Delaying child marriage through community-based skills-development programs for girls: Results from a randomized controlled study in rural Bangladesh.

    BACKGROUND

  • Coates J, Swindale A, Bilinsky P. Household Food Insecurity Access Scale (HFIAS) for Measurement of Food Access: Indicator Guide. Washington, D.C.; 2007.

    BACKGROUND

  • FANTA, FAO. Introducing the Minimum Dietary Diversity - Women (MDD-W) Global Dietary Diversity Indicator for Women. 2014;2014-5. Available from: http://www.fantaproject.org/monitoring-and-evaluation/minimum-dietary-diversity-women-indicator-mddw

    BACKGROUND

  • World Food Programme. Food consumption analysis: Calculation and use of the food consumption score in food security analysis [Internet]. Rome, Italy; 2008. Available from: http://library1.nida.ac.th/termpaper6/sd/2554/19755.pdf

    BACKGROUND

  • Home - Equity Tool [Internet]. [cited 2021 Jan 3]. Available from: https://www.equitytool.org/

    BACKGROUND

  • Schwarzer, R., & Jerusalem M (1995). General Self-Efficacy Scale (GSE). 1995.

    BACKGROUND

  • Bangladesh Multiple Indicator Cluster Survey 2012-2013. Progotir Pathey: Final Report. Dhaka, Bangladesh.: Bangladesh Bureau of Statistics (BBS) and UNICEF Bangladesh.; 2013.

    BACKGROUND

  • HKI. State of food security and nutrition in Bangladesh: 2013. 2014

    BACKGROUND

  • Human Rights Watch. Marry Before Your House is Swept Away. 2015.

    BACKGROUND

  • JPGSPH. The state of the world's children. 2016. 1-63 p.

    BACKGROUND

  • NIPORT. BANGLADESH DEMOGRAPHIC AND HEALTH SURVEY 2016. 2016.

    BACKGROUND

  • Karim N, Greene M, Picard M. The cultural context of child marriage in Nepal and Bangladesh: findings from CARE's tipping point project community participatory analysis: research report. 2016

    BACKGROUND

  • Bangladesh Bureau of Statistics and UNICEF Bangladesh. A Scoping Analysis of Budget Allocations for Ending Child Marriage in Bangladesh 2017. 2018.

    BACKGROUND

  • ICRW, Plan. Asia Child Marriage Initiative : Summary of Research in Bangladesh, India and Nepal. UNICEF Glob database. 2013

    BACKGROUND

Related Links

MeSH Terms

Conditions

Adolescent BehaviorHealth BehaviorCoitus

Condition Hierarchy (Ancestors)

BehaviorSexual Behavior

Study Officials

  • Aminuzzaman Talukder, MPH

    Helen Keller International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Monitoring, Evaluation and Research

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 17, 2021

Study Start

February 1, 2021

Primary Completion

March 30, 2021

Study Completion

March 15, 2023

Last Updated

August 25, 2021

Record last verified: 2021-08

Locations

BA(1)