A Livelihood Intervention for Impoverished Women in Rural Uganda

December 1, 2015 updated by: Alexander Tsai, Massachusetts General Hospital

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

The objective of the study is to determine whether a livelihood intervention can improve economic and psychosocial wellbeing in rural Uganda.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mbarara, Uganda
        • Recruiting
        • Mbarara University of Science and Technology
        • Principal Investigator:
          • Alexander C Tsai, MD, PhD
        • Principal Investigator:
          • Bernard Kakuhikire, MBA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged 18-60 years (or emancipated minors aged 16-17 years) who live with at least one child under the age of 5 in the same household
  • Women aged 18-60 years (or emancipated minors aged 16-17 years) who agree to participate in the livelihood intervention training program
  • Women aged 18-60 years (or emancipated minors aged 16-17 years) who agree to participate in study data collection

Exclusion Criteria:

  • Men
  • Women who do not live in Nyakabare Parish
  • Women under 18 years of age (if not emancipated minors) or older than 60 years of age
  • Women who do not live with at least one child under the age of 5 in the same household
  • Women who decline to participate in the livelihood intervention training program
  • Women who decline to participate in study data collection
  • Women who live in the same household as another study participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate treatment
Participants 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
Participants 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 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
Household Food Insecurity Access Scale
Time Frame: 12 months
Scale items range from 0 (never) to 3 (more than 10 days in the past month)
12 months
Hopkins Symptom Checklist Scale
Time Frame: 12 months
Scale items range from 1 (not at all) to 4 (very much)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intimate Partner Violence Scale
Time Frame: 12 months
Experience (yes/no) of 12 different forms of emotional, sexual, or physical victimization by an intimate partner (range 0-12)
12 months
Norms about Intimate Partner Violence Scale
Time Frame: 12 months
Agreement (yes/no) with 5 different statements about the acceptability of intimate partner violence under 5 different scenarios (range, 0-5)
12 months
Self-Reported Health Scale
Time Frame: 12 months
Scale item ranges from 1 (very bad) to 4 (very good)
12 months
Decision Making Power Scale
Time Frame: 12 months
Primary decision making (yes/no) on household expenditures in 7 different categories: food, livestock, health care, transport, social, educational, other household (range, 0-7)
12 months
Social Integration Scale
Time Frame: 12 months
Frequency of participation in 11 different community groups: vocational, positive living, local council, water, village health, agricultural extension, savings, religious, women's, gardening (range, 0-11)
12 months
Social Capital Scale
Time Frame: 12 months
Agreement (yes/no) with 4 questions about social trust and social cohesion (range, 0-4)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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-S3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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