Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.

NCT07011264 | Not Yet Recruiting DMC

• 2 other identifiers: UUtah1K01TW012427-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Refine and adapt the BAJJAJJA intervention components through a collaborative and iterative feedback process with a diverse community group of 18 members;
2. 2.Test the feasibility, acceptability and preliminary efficacy of the BAJJAJJA intervention in improving economic and health outcomes among 24 Ugandan GMCs; and
3. 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.

Conditions

Financial Burden; Health Behavior; Social Support

Keywords

NIH Stage Model; intervention testing; intervention development; physical challenges; mental challenges; financial stress; Ugandan grandmother-caregivers

Outcome Measures

Primary Outcomes (7)

• 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).

  Baseline, 12-months, and 6- months post-intervention (18- months)

• 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.

  Baseline, 12-months, and 6- months post-intervention (18- months)

• 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.

  Baseline, 12-months, and 6- months post-intervention (18- months)

• 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.

  Baseline, 12-months, and 6- months post-intervention (18- months)

• Social Support: Duke-University of North Carolina Functional Social Support Questionnaire (Duke-UNC FSSQ)

  The Duke-University of North Carolina Functional Social Support Questionnaire measures a person's satisfaction with the functional aspects of social support. Scoring Range: The Duke-University of North Carolina Functional Social Support Questionnaire is scored on a 5-point Likert scale ranging from 1 (Much less than I would like) to 5 (As much as I would like). The total score ranges from 8 to 40. Interpretation: Higher scores indicate a better outcome, meaning greater perceived functional social support. Lower scores suggest less perceived support.

  Baseline, 12-months, and 6- months post-intervention (18- months)

• Food Insecurity & Household Income: Household Food Insecurity Access Scale (HFIAS)

  9-item instrument that addresses 3 domains of core experiences: uncertainty or anxiety about food supply; insufficient food quality; and insufficient food intake and its physical consequences Scoring Range: The Household Food Insecurity Access Scale is scored from 0 to 3 based on frequency of occurrence: 0 = Never 1. = Rarely (once or twice in the past four weeks) 2. = Sometimes (three to ten times) 3. = Often (more than ten times) Total score range: 0 to 27 Interpretation: Higher scores indicate a worse outcome, meaning greater household food insecurity. Lower scores reflect better food access and food security.

  Baseline, 12-months, and 6- months post-intervention (18- months)

• Readiness to Change: Readiness to Change Questionnaire (RCQ)

  2-item to assess where individuals are in the cycle of change to inform goal setting, actions, and determine the best strategies. Scoring Range: The Readiness to Change Questionnaire is divided into three response subscales: Precontemplation, Contemplation. Action. Each item is scored from 1 (Strongly disagree) to 5 Scoring Range: The Readiness to Change Questionnaire is divided into three response subscales: Precontemplation, Contemplation. Action. Each item is scored from 1 (Strongly disagree) to 5 (Strongly agree). Interpretation: There is no single total score for the Readiness to Change Questionnaire; rather, the highest subscale score indicates the participant's current stage of readiness to change. Higher scores in the "Action" subscale suggest a better outcome, reflecting greater readiness to change. Higher scores in the Precontemplation stage indicate lower readiness (worse outcome in terms of behavior change).Contemplation is a middle stage of ambivalence or consideration.

  Baseline, 12-months, and 6- months post-intervention (18- months)

Secondary Outcomes (3)

• Feasibility & Acceptability: Demographic and Clinical Data Form

  Baseline, 12-months, and 6- months post-intervention (18- months)

• Sustainability & Maintenance: Semi-structured & structured questionnaires

  Baseline, 12-months, and 6- months post-intervention (18- months)

• Fidelity Monitoring

  Baseline, 12-months, and 6- months post-intervention (18- months)

Other Outcomes (5)

• Weight

  Baseline, 12-months, and 6- months post-intervention (18- months)

• Height

  Time Frame: Baseline, 12-months, and 6- months post-intervention (18- months)

• Body Mass Index (BMI)

  Time Frame: Baseline, 12-months, and 6- months post-intervention (18- months)

Study Arms (1)

Economic Empowerment and Health Promotion

EXPERIMENTAL

In this study, all 24 participants will engage in two intervention components constituting of an income generating activity (e.g. poultry farming) and health coaching (facilitated by visiting nurses).

Behavioral: The BAJJAJJA intervention

Interventions

The BAJJAJJA intervention BEHAVIORAL

The 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.

Economic Empowerment and Health Promotion

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• 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)

You may not qualify if:

• Participants will be excluded if they:
• Are cohabitating with their adult children
• Are grandmothers under the age of 50

Sponsors & Collaborators

• University of Utah: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Makerere University: collaborator

Study Sites (1)

University of Utah College of Nursing

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Matovu S, Dawson-Rose C, Weiss S, Wallhagen M. "Thoughts Can Kill You": Characterization of Mental Health Symptoms by Ugandan Grandparent-Caregivers in the HIV/AIDS Era. Issues Ment Health Nurs. 2019 May;40(5):391-398. doi: 10.1080/01612840.2018.1553001. Epub 2019 Mar 27.

  PMID: 30917054 BACKGROUND

MeSH Terms

Conditions

Financial Stress; Health Behavior

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Schola N Matovu, PhD

CONTACT

18015879196; schola.matovu@nurs.utah.edu

Lee Ellington, PhD

CONTACT

lee.ellington@nurs.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study will use the NIH Stage Model of behavioral intervention development following these stages: Stage IA: Intervention development (our preliminary work), Stage IB: Intervention refinement, modification, and adaptation and pilot testing (proposed/current study), Stage II: efficacy testing (future/subsequent study),

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: June 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2029
• Last Updated: August 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)