A Livelihood Intervention for Impoverished Women and Children in Rural Uganda

A Livelihood Intervention for Impoverished Women and Children in Rural Uganda: Randomized Controlled Trial

The objective of the study is to determine whether a livelihood intervention can improve health and schooling outcomes of the children of woman participating in a livelihood intervention in rural Uganda.

Study Overview

• Status: Unknown
• Conditions: Indigency
• Intervention / Treatment: Other: Livelihood intervention

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Mbarara, Uganda
    • Recruiting
    • Mbarara University of Science and Technology
    • Contact: Alexander C Tsai, MD, PhD; Phone Number: 617-724-1120; Email: actsai@partners.org
    • Principal Investigator: Alexander C Tsai, MD, PhD
    • Principal Investigator: Bernard Kakuhikire, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All children under 18 years

Exclusion Criteria:

• Adults older than 18 years

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate treatment; Participants' mothers will receive a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises	Other: Livelihood intervention; Participants' mothers will receive a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises.
No Intervention: Delayed treatment; Participants' mothers will receive no intervention but will be placed on a waitlist to receive the intervention after a 12-month delay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stunting based on Anthropometric Measurements	Height-for-age calculated based on child height and child age, measured for children under 5 years of age	12 months
Weight-for-Height based on Anthropometric Measurements	Weight-for-height calculated based on child height and child weight, measured for children under 5 years of age	12 months
Raven's Colored Progressive Matrices test	Raven's Colored Progressive Matrices test score (range, 0-18), measured for children aged 5-8 years	12 months
Mullen Early Learning Scales	Mullen Early Learning Scales: 144 items total, divided across 4 subtests in visual receptive organization, visual expressive organization, language expressive organization, and language receptive organization	12 months
Home Observation of the Measurement of Environment Scale	Home Observation of the Measurement of Environment, modified for the Ugandan context (58 items distributed across the following domains: Responsivity, Encouragement of maturity, Emotional climate, Learning materials and opportunities, Enrichment, Family companionship, Family integration and Physical environment)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Educational Investment Scale	Average time spent on school and schoolwork in the past 7 days (number of hours)	12 months
Child Non-Educational Investment Scale	Average time spent on household chores and playing in the past 7 days (number of hours)	12 months
Mother's Educational Investment Scale	Average time spent on reading to children or helping with homework in past 7 days (number of hours)	12 months
Mother's Aspirations for Child Education Scale	Mother's aspiration for child's educational attainment, ranging from 1 (finish P7 primary school) to 5 (finish graduate school)	12 months
Mother's Aspirations for Child Career Scale	Mother's aspirations for child's adult employment by age 25 (with the option to select one of 33 different blue-collar and white-collar occupational categories)	12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Mbarara University of Science and Technology
• Investigators: Principal Investigator: Alexander C Tsai, MD, PhD, Massachusetts General Hospital; Principal Investigator: Bernard Kakuhikire, MBA, Mbarara University of Science and Technology

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 15, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 2, 2015

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: MH096620-S4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No