Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity of Utah
About this trial
Background:
There are an estimated 163 million children worldwide who are under the care of their grandparents or other relatives. In Uganda, social determinants of health (i.e., poverty, wars, and maternal and perinatal conditions) threaten the middle generation (age 15-49) and leave older adults, especially grandmothers (Bajjajja), to become the safety net. Yet, in this region, knowledge about effective interventions that support the health and wellbeing of these GMCs is limited to nonexistent. As such, Dr. Matovu proposes to refine, adapt, and test her BAJJAJJA intervention that she developed.
Specific Aims:
Dr. Matovu will achieve this goal through three Specific Aims:
1. Refine and adapt the BAJJAJJA intervention components through a collaborative and iterative feedback process with a diverse community group of 18 members; 2. Test the feasibility, acceptability and preliminary efficacy of the BAJJAJJA intervention in improving economic and health outcomes among 24 Ugandan GMCs; and 3. Explore the barriers and facilitators to (3a) maintenance of the BAJJAJJA individual intervention benefits and (3b) sustainability of the income generating activity at 6 months post-intervention.
This innovative study will utilize a community-engaged approach that emphasizes the meaningful involvement of community partners to develop an intervention that targets GMCs. Her outcomes will support her future efficacy clinical trial to test a novel multi-component and community-engaged BAJJAJJA intervention to promote the mental, physical, and economic wellbeing of GMCs.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female, aged 50 years or older (reflecting the post-reproductive age range in Uganda)
Luganda-speaking (commonly spoken language).
Primary caregiver of at least one minor grandchild (under 18 years) for more than six months
Able to independently perform activities of daily living (e.g., cooking, bathing)
Disqualifiers
Are cohabitating with their adult children
Are grandmothers under the age of 50
Trial design
Design model
Single group
Treatments tested in this trial
The BAJJAJJA intervention
BehavioralThe BAJJAJJA intervention is composed of: The IGA COMPONENT which is intended to promote economic empowerment by improving household income based on available resources. The component will consist of a series of 1-hour sessions with 3 separate GMC participant groups (8 GMCs per group). Two IGA experts will lead these sessions, weekly for the first two months and later monthly for the remaining 10 months of the 12-month intervention period. The HEALTH COACHING COMPONENT will be informed by theChronic Disease Self-Management Education (CDSME) framework.54 This community-based, person-centered care model will be used to empower GMCs to manage their health through goal-setting, problem-solving, and chronic disease self-monitoring. I (PI) will leverage the community networks that I developed during my preliminary work to (1) recruit interventionists (two nurses) and (2) ensure their adequate training and adherence to the intervention manuals and procedures.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Economic Empowerment and Health PromotionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mental and Physical Health: Short Form Health Survey - 12-Item Version (SF-12)
12 item self-reported outcome measure that assesses the impact of health on an individuals everyday life. It addresses 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role and mental health. Scoring Range: Physical Component Summary (PCS) \& Mental Component Summary (MCS): typically ranges from 0 to 100 Interpretation: Higher scores on both the PCS and MCS indicate better health outcomes (better physical functioning and mental well-being).
Time frame
Baseline, 12-months, and 6- months post-intervention (18- months)2
Caregiver Strain: Zarit Burden Interview (ZBI)
13 questions to measure caregiver strain in at least one of the following domains: Financial, Physical, Psychological, Social, and Personal. Scoring Range: The standard 22-item version of the Zarit Burden Interview has a total score range from 0 to 88. Each item is scored on a scale from 0 (Never) to 4 (Nearly Always). Interpretation: Higher scores indicate a worse outcome, meaning greater caregiver strain or burden. Lower scores suggest less perceived burden.
Time frame
Baseline, 12-months, and 6- months post-intervention (18- months)3
Self-Efficacy: Short Form of General Self-Efficacy Scale (GSE-6)
6-item Short Form of General Self-Efficacy Scale assesses a sense of perceived self-efficacy aimed to predict coping and adaptation with stress Scoring Range: The 6-item short form has a total score range from 6 to 30. Each item is typically rated on a 5-point Likert scale from 1 (Not at all true) to 5 (Exactly true). Interpretation: Higher scores indicate a better outcome, meaning greater self-efficacy. Lower scores suggest less confidence in one's ability to cope with challenges or exert control over life circumstances.
Time frame
Baseline, 12-months, and 6- months post-intervention (18- months)4
Economic Empowerment: Women's Empowerment in Agriculture Index (WEAI)
12 indicators including, autonomy in income, self-efficacy, ownership of land and other assets, access to and decisions on credit, control over use of income, work balance, group membership, etc. Scoring Range: The Women's Empowerment in Agriculture Index score ranges from 0 to 1. Interpretation: Higher scores indicate a better outcome, meaning greater empowerment in agriculture-related domains. A score of 1.0 represents full empowerment, while a score closer to 0 indicates low empowerment.
Time frame
Baseline, 12-months, and 6- months post-intervention (18- months)Secondary outcomes
1
Feasibility & Acceptability: Demographic and Clinical Data Form
Assess items which may contribute to health disparity, stress, and participation in healthy lifestyle behaviors (income, marital status, grandchildren, education level attained, etc.).
Time frame
Baseline, 12-months, and 6- months post-intervention (18- months)2
Sustainability & Maintenance: Semi-structured & structured questionnaires
To explore barriers and facilitators to maintenance and sustainability of targeted individual health and IGA outcomes.
Time frame
Baseline, 12-months, and 6- months post-intervention (18- months)3
Fidelity Monitoring
\# of participants: screened for eligibility; assessed at timepoints, participated in intervention sessions.
Time frame
Baseline, 12-months, and 6- months post-intervention (18- months)Other outcomes
1
Weight
* Measurement Method: Participants' weight will be measured using a calibrated digital scale. * Units: Kilograms (kg) * Procedure: Participants will be asked to remove shoes and any heavy clothing. The weight will be recorded to the nearest 0.1 kg.
Time frame
Baseline, 12-months, and 6- months post-intervention (18- months)2
Height
* Measurement Method: Height will be measured using a stadiometer. * Units: Meters (m) * Procedure: Participants will stand upright without shoes, with their back against the stadiometer, and height will be recorded to the nearest 0.1 cm (then converted to meters).
Time frame
Time Frame: Baseline, 12-months, and 6- months post-intervention (18- months)3
Body Mass Index (BMI)
o Calculation Method: BMI will be calculated using the formula: BMI = Weight (kg) / \[Height (m)\]² * Units: kg/m² * Interpretation: BMI values will be categorized according to WHO guidelines (e.g., underweight, normal, overweight, obese).
Time frame
Time Frame: Baseline, 12-months, and 6- months post-intervention (18- months)4
Blood Pressure
* Measurement Method: Blood pressure will be measured using an automated digital sphygmomanometer. * Units: Millimeters of mercury (mmHg) * Procedure: Measurements will be taken on the participant's upper arm after 5 minutes of rest, in a seated position. Two readings will be taken at 1-minute intervals, and the average of the two readings will be used for analysis. * Reported Values: Systolic and diastolic blood pressure (e.g., 120/80 mmHg)
Time frame
Time Frame: Baseline, 12-months, and 6- months post-intervention (18- months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
Makerere University
Collaborator
Source ClinicalTrials.gov
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