Transform Randomised Control Trial in Uganda

NCT05882097 | Unknown

• 1 other identifier: icmugrct
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Health Behavior; Economic Problems; Values, Social

Keywords

values; livelihood; health; program evaluation; intervention; poverty; poverty reduction; Uganda; randomized control trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 6 and 12 months

Secondary Outcomes (1)

• Change from baseline in duckworth index at 6 and 12 months

  Baseline, 6 and 12 months

Study Arms (2)

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.

Other: Transform program

Control arm receiving no Transform program

NO INTERVENTION

Control: Participants will not receive any intervention during the study period.

Interventions

Transform program OTHER

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.

Also known as: Poverty alleviation program

Treatment arm receiving the Transform program

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Care Ministries, Philippines: lead

Study Sites (1)

ICM Uganda

Kampala, Kibuye, 15100, Uganda

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lincoln L Lau, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not know which group they belong to. Due to procedures to implement the study, it is inevitable that the operations team will know who will belong to the control and treatment arms (control participants will not receive the Transform program). This study will be a single masked study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 31, 2023
• Study Start: August 3, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)