Health BehaviorNCT05882097
Transform Randomised Control Trial in Uganda
A study testing Transform program in people with Health Behavior and Economic Problems, run by International Care Ministries, Philippines at 1 site in Uganda.
Trial summary
In recent decades, the poverty rate in Uganda decreased by more than half, from 56% in 1992/1993 to 21.4% in 2019/2020. However, Uganda remains as one of the poorest countries in the world. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Economic Problems, Values, Social
- What is being tested?
- Transform program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 1 siteUganda
- Study dates
- 3 Aug 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
In recent decades, the poverty rate in Uganda decreased by more than half, from 56% in 1992/1993 to 21.4% in 2019/2020. However, Uganda remains as one of the poorest countries in the world. Recognising that poverty is a multifaceted issue, International Care Ministries (ICM), a non-profit organisation, implements a program called Transform to target households living in poverty from 3 dimensions: values, livelihood and health. ICM first started the Transform program in the Philippines and recently expanded to Uganda and Guatemala. The program includes 15 sessions and delivers them to the participants during the course of a 4-month period. Previously, three randomised control trials found positive impacts of Transform on certain poverty indicators in the Philippines. Although positive impacts were found in the Philippines, the effectiveness of Transform in Uganda is unknown.
Read the detailed description
International Care Ministries (ICM) is a non-governmental organisation with a mission to reduce the burden of extreme poverty. ICM focused its work in the Philippines for more than 30 years and recently expanded to Uganda and Guatemala. The core poverty alleviation program at ICM is called Transform. Transform focuses on improving values, health and livelihood through a 15-week program (1 lesson per week). ICM has conducted three randomized controlled trials (RCT) in the Philippines. This RCT was designed in response to the expansion of ICM's work in Uganda. Realising the poverty issue that was exacerbated by the COVID-19 pandemic, ICM implemented its first Transform program in Uganda in 2020. As of May 2023, more than 210 communities and 5,921 participants received the Transform program in the regions of Kiboga and Kyankwanzi. Despite the fact that previous RCTs found a positive impact of Transform on certain poverty indicators in the Philippines, the effectiveness of Transform is not known in another context. The Philippines and Uganda are vastly different in terms of their economies, cultures and demographics. This study builds on the previous RCTs and aims to evaluate the Transform program on measures of economic outcomes, social capital, health, hope and spiritual well-being in a different context. Whether there will be similar results in Uganda will deepen perspectives in the universal elements of success that can be further adopted and scaled up in other countries. While a key challenge in poverty alleviation initiatives is the lack of high quality evidence to evaluate the effectiveness of programs, this study will use the gold standard of effectiveness research - RCT, to deepen understanding in the causal impact of the Transform program in another context.
- Conditions
- Health Behavior, Economic Problems, Values, Social
- Being tested
- Transform program
- Keywords
- values, livelihood, health, program evaluation, intervention, poverty, poverty reduction, Uganda, randomized control trial
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transform programOther
Also called Poverty alleviation program
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm receiving the Transform program | Experimental | 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. Receives: Other: Transform program |
| Control arm receiving no Transform program | No intervention | Control: Participants will not receive any intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in EuroQol-5 Dimension - 5 levels (EQ-5D-5L) at 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.
Measured: Baseline, 6 and 12 months
Change from baseline in poverty probability index at 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.
Measured: Baseline, 6 and 12 months
Secondary outcomes (1)
Change from baseline in duckworth index at 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.
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start3 Aug 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a cluster-randomised controlled trial. A total of 4,800 participants from 160 communities will be randomly assigned to one of the two treatment arms: Transform and Control. The treatment will be assigned at the community level, so all participating households in a community will be in the same treatment arm. This will prevent dissemination of information and mixing of control and treatment groups among the participants. The RCT will be rolled out in two batches. For each batch (i.e. 40 communities), a list of eligible communities will be drawn up and randomised into one of the treatment arms. To reduce the risk of bias, communities and participants will be recruited before the clusters have been randomly allocated.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Care Ministries, Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lincoln Lau, International Care Ministries, Philippines
- Investigators
- Lincoln L Lau, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882097
- Sponsor's protocol ID
- icmugrct
- Status last verified
- Aug 2023
- First submitted
- 11 May 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transform Randomised Control Trial in Uganda
- ClinicalTrials.gov ID
- NCT05882097
- Acronym / sponsor ID
- icmugrct
- Conditions
- Health Behavior, Economic Problems, Values, Social
- Keywords
- values, livelihood, health, program evaluation, intervention, poverty, poverty reduction, Uganda
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- International Care Ministries, PhilippinesUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent decades, the poverty rate in Uganda decreased by more than half, from 56% in 1992/1993 to 21.4% in 2019/2020. However, Uganda remains as one of the poorest countries in the world. Recognising that poverty is a multifaceted issue, International Care Ministries (ICM), a non-profit organisation, implements a program called Transform to target households living in poverty from 3 dimensions: values, livelihood and health. ICM first started the Transform program in the Philippines and recently expanded to Uganda and Guatemala. The program includes 15 sessions and delivers them to the participants during the course of a 4-month period. Previously, three randomised control trials found positive impacts of Transform on certain poverty indicators in the Philippines. Although positive impacts were found in the Philippines, the effectiveness of Transform in Uganda is unknown.
Detailed description
International Care Ministries (ICM) is a non-governmental organisation with a mission to reduce the burden of extreme poverty. ICM focused its work in the Philippines for more than 30 years and recently expanded to Uganda and Guatemala. The core poverty alleviation program at ICM is called Transform. Transform focuses on improving values, health and livelihood through a 15-week program (1 lesson per week). ICM has conducted three randomized controlled trials (RCT) in the Philippines. This RCT was designed in response to the expansion of ICM's work in Uganda. Realising the poverty issue that was exacerbated by the COVID-19 pandemic, ICM implemented its first Transform program in Uganda in 2020. As of May 2023, more than 210 communities and 5,921 participants received the Transform program in the regions of Kiboga and Kyankwanzi. Despite the fact that previous RCTs found a positive impact of Transform on certain poverty indicators in the Philippines, the effectiveness of Transform is not known in another context. The Philippines and Uganda are vastly different in terms of their economies, cultures and demographics. This study builds on the previous RCTs and aims to evaluate the Transform program on measures of economic outcomes, social capital, health, hope and spiritual well-being in a different context. Whether there will be similar results in Uganda will deepen perspectives in the universal elements of success that can be further adopted and scaled up in other countries. While a key challenge in poverty alleviation initiatives is the lack of high quality evidence to evaluate the effectiveness of programs, this study will use the gold standard of effectiveness research - RCT, to deepen understanding in the causal impact of the Transform program in another context.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a cluster-randomised controlled trial. A total of 4,800 participants from 160 communities will be randomly assigned to one of the two treatment arms: Transform and Control. The treatment will be assigned at the community level, so all participating households in a community will be in the same treatment arm. This will prevent dissemination of information and mixing of control and treatment groups among the participants. The RCT will be rolled out in two batches. For each batch (i.e. 40 communities), a list of eligible communities will be drawn up and randomised into one of the treatment arms. To reduce the risk of bias, communities and participants will be recruited before the clusters have been randomly allocated.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm receiving the Transform program | Experimental | Other: Transform programTransform: 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. |
| Control arm receiving no Transform program | No intervention | –Control: Participants will not receive any intervention during the study period. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transform programAlso: Poverty alleviation programInternational 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 | Treatment arm receiving the Transform program |
Primary outcome
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.
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.
1 secondary outcome
Change from baseline in duckworth index at 6 and 12 months
Time frame: Baseline, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- BackgroundOwori 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.
- BackgroundBryan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lincoln L Lau, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transform program in people with Health Behavior and Economic Problems, run by International Care Ministries, Philippines at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882097, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.