- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02619227
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
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
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-
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Mbarara, Uganda
- Recruiting
- Mbarara University of Science and Technology
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Principal Investigator:
- Alexander C Tsai, MD, PhD
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Principal Investigator:
- Bernard Kakuhikire, MBA
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Contact:
- Alexander Tsai, MD, PhD
- Phone Number: 617-724-1120
- Email: actsai@partners.org
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-
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
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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.
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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.
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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)
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12 months
|
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Hopkins Symptom Checklist Scale
Time Frame: 12 months
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Scale items range from 1 (not at all) to 4 (very much)
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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)
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12 months
|
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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)
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12 months
|
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Self-Reported Health Scale
Time Frame: 12 months
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Scale item ranges from 1 (very bad) to 4 (very good)
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12 months
|
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Decision Making Power Scale
Time Frame: 12 months
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Primary decision making (yes/no) on household expenditures in 7 different categories: food, livestock, health care, transport, social, educational, other household (range, 0-7)
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12 months
|
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Social Integration Scale
Time Frame: 12 months
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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)
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12 months
|
|
Social Capital Scale
Time Frame: 12 months
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Agreement (yes/no) with 4 questions about social trust and social cohesion (range, 0-4)
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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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