- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05882097
Transform Randomised Control Trial in Uganda
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonah Mugabi
- Phone Number: +256783457253
- Email: jonah.mugabi@caremin.com
Study Contact Backup
- Name: Henry Kizza
- Phone Number: +256-705520719
- Email: henry.kizza@caremin.com
Study Locations
-
-
Kibuye
-
Kampala, Kibuye, Uganda, 15100
- ICM Uganda
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Poverty score of 50 and above in the Philippine Poverty Score Card Survey qualifies the person into Transform. Higher score indicates poorer households.
- Only the top 30 poorest household will be selected once the community gets approve to host the Transform program.
Exclusion Criteria:
- Participants who are above the threshold using the poverty score card (less than 50) will be excluded from the study.
- Households also cannot participate in the study if they have previously received the Transform program, unless the implementation team overrides the score due to specific circumstances that only affect a minority of participants.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment arm receiving the Transform program
Transform: Participants will receive ICM's Transform program. In the treatment arm, the full 15-session Transform program will be delivered once a week for 15 consecutive weeks in a venue located within the community. In each session, there will be 90 minutes lessons on livelihood and health delivered by trained ICM staff. Separately, a voluntary values lesson will be delivered by the host community leader. |
International Care Ministries' (ICM) Transform is a 15-lesson, 15-week long values, health, and livelihood program that targets some of the poorest households in Uganda.
The health dimension focuses on increasing health knowledge and behaviours on a range of health topics such as malnutrition, respiratory infection, lifestyle, sanitations, family planning and infant care.
The livelihood dimension focuses on increasing the amount and sources of household income.
Participants will learn about business ideas and farming techniques to diversify their income sources.
Additionally, a savings group will be formed at the end of Transform to promote a sustainable strategy to reduce poverty among the participants.
The values dimension will focus on relationships, personal character and decision making aspects of an individual.
Other Names:
|
No Intervention: Control arm receiving no Transform program
Control: Participants will not receive any intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in EuroQol-5 Dimension - 5 levels (EQ-5D-5L) at 6 and 12 months
Time Frame: Baseline, 6 and 12 months
|
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire.
The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Values are anchored at 1 (full health) and 0 (a state as bad as being dead).
Values less than 0 represent health states regarded as worse than a state that is as bad as being dead.
Higher value indicate better health state.
|
Baseline, 6 and 12 months
|
Change from baseline in poverty probability index at 6 and 12 months
Time Frame: Baseline, 6 and 12 months
|
The Poverty Probability Index (PPI®) is a poverty measurement tool for organizations and businesses with a mission to serve the poor.
The answers to 10 questions about a household's characteristics and asset ownership are scored to compute the likelihood ranged from 0 to 1 to indicate how likely the household is living below the poverty line.
The higher the probability means that more likely the household is poor.
|
Baseline, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in duckworth index at 6 and 12 months
Time Frame: Baseline, 6 and 12 months
|
Duckworth index measures grit scale on trait-level perseverance and passion for long term goals.
This will explore participants characteristic on grit in relations to changes in other variables.
The index score ranged from 0 to 5. Higher score indicates greater level of grit.
|
Baseline, 6 and 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lincoln L Lau, PhD, University of Toronto
Publications and helpful links
General Publications
- Owori M. Poverty in Uganda: National and regional data and trends. Development Initiatives. https://devinit. org/resources/poverty-uganda-national-and-regional-data-and-trends. 2020 Oct.
- Bryan G, Choi JJ, Karlan D. Randomizing religion: the impact of Protestant evangelism on economic outcomes. The Quarterly Journal of Economics. 2021 Feb;136(1):293-380.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- icmugrct
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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