ClinicalTrials.gg
CompletedNCT07175064MMSUpdated Sep 16, 2025

Nursing-Led Livelihood Programs and Women's Health

An observational study in Nutrition Disorders, Stress, Psychological and Mental Health Issue, sponsored by Angeles University Foundation. Completed at 1 site in Philippines. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Angeles University Foundation · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
25
Ages
18 Years and older
Sex
Female
01

Study summary

This study aims to evaluate the socioeconomic and health impacts of nursing-led livelihood programs among indigenous women in Sitio Monicayo, Pampanga, Philippines. The programs, initiated in 2016, include bracelet making, rag making, and liquid dishwashing. Using an explanatory sequential mixed methods design, Phase 1 surveys Aeta women to assess changes in household income, employment, and six domains: Program Benefits, Facilitation, Self-Confidence, Resilience, Future Intentions, and Barriers. Nonparametric analyses are used to examine program outcomes. Phase 2 involves semi-structured interviews with a subset of participants to contextualize quantitative results, focusing on nutrition, stress reduction, access to medicines, preventive care, and caregiving. Integration through joint displays is planned to highlight alignment and discordance between survey scores and lived experiences. The study seeks to explore the role of nursing-led livelihood interventions in addressing both economic empowerment and social determinants of health, in alignment with the Sustainable Development Goals on poverty, good health and well-being, and decent work.

Read the detailed description

This study investigates the socioeconomic and health outcomes of nursing-initiated livelihood programs implemented among indigenous Aeta women in Sitio Monicayo, Pampanga, Philippines. The livelihood programs-bracelet making, rag making, and liquid dishwashing-were introduced in 2016 by nursing faculty in partnership with the local community. The research employs an explanatory sequential mixed methods design.

In Phase 1, a nonrandomized cross-sectional survey is conducted with Aeta women who have participated in the livelihood programs for at least six months. Outcomes include household income change, employment shifts, and six composite domains: Program Benefits, Facilitation, Self-Confidence, Resilience, Future Intentions, and Barriers. Nonparametric analyses (Wilcoxon signed-rank, McNemar-Bowker, Kruskal-Wallis, and Spearman's correlations) are performed using SPSS v29.

In Phase 2, semi-structured interviews are conducted with a purposively selected subgroup of participants to contextualize the quantitative findings. Interviews explore barriers and enablers of participation, and their impact on nutrition, stress reduction, preventive care, and caregiving roles. Thematic analysis follows Braun and Clarke's framework, with member checking used to validate findings. Integration is achieved through joint displays to align, complement, or contrast quantitative and qualitative outcomes.

Data quality assurance: Data entry is checked for completeness and internal consistency. Predefined rules for range and coding consistency are applied across variables. A pilot test is conducted before main data collection to ensure reliability and validity of measures. Source data verification is performed by cross-checking survey and interview records with program participation logs.

Sample size: The sample size (N=25 for survey, n=10 for interviews) is based on available program participants and is designed to capture both breadth and depth of experience.

Statistical analysis plan: The primary quantitative outcomes are household income change and employment shifts. Secondary outcomes include composite scores for empowerment and barriers. Qualitative findings are coded inductively and deductively, and integrated with quantitative data to explain mechanisms and identify discordances.

This study was reviewed and approved by the Angeles University Foundation Ethics Review Committee (2024-CON-Faculty-004).

02

Conditions studied

  • Nutrition Disorders
  • Stress, Psychological
  • Mental Health Issue

Keywords

  • Community Health Nursing
  • Women's Health
  • Indigenous Peoples
  • Philippines
  • Empowerment
03

In context

Nutrition Disorders

233 studies on the registry are indexed under Nutrition Disorders; 26 are open to participants now.

This study's enrollment of 25 is below the median of 108 across 57 observational studies indexed under Nutrition Disorders.

Browse Nutrition Disorders studies →

Lead sponsor

Angeles University Foundation is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants were indigenous Aeta women residing in Sitio Monicayo, Pampanga, Philippines, who engaged in nursing-initiated livelihood programs introduced in the community in 2016. The programs were facilitated by nursing faculty in collaboration with local leaders as part of a long-term community health partnership.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older
  • Member of the Aeta community in Sitio Monicayo, Pampanga, Philippines
  • Participation in at least one nursing-initiated livelihood program (bracelet making, rag making, or liquid dishwashing) for a minimum of six months
  • Willing and able to provide

Exclusion criteria

Exclusion Criteria:

  • Not a resident of Sitio Monicayo or not part of the Aeta community
  • Did not participate in the livelihood programs or participated for less than six months
  • Unwilling or unable to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • Livelihood Program Participants

    Adult Aeta women, aged 18 years and older, residing in Sitio Monicayo, Pampanga, who have been active participants in nursing-initiated livelihood programs for at least six months prior to enrollment. Participants were selected based on their involvement in bracelet making, rag making, or liquid dishwashing initiatives facilitated by nursing faculty in partnership with local community leaders.

    Behavioral: Nursing-Led Livelihood Programs

Interventions

  • BehavioralNursing-Led Livelihood Programs

    A set of community-based livelihood initiatives introduced in 2016 and facilitated by nursing faculty in partnership with local leaders. Activities included bracelet making, rag making, and liquid dishwashing. The programs aimed to provide sustainable income, build women's confidence and skills, and indirectly improve health outcomes by addressing poverty-related social determinants of health.

06

What researchers measure

Primary outcomes

  1. Household Income Change

    Change in reported monthly household income before and after participation in livelihood programs, measured using self-reported survey data. Analyzed using Wilcoxon signed-rank test.

    Time frame: (pre-program, recalled) and at enrollment (current, 2024)

  2. Employment Status Shift

    Change in primary employment status (self-employment, wage work, farming/fishing, or unemployed) before and after program participation, measured using categorical survey data. Analyzed using McNemar-Bowker test.

    Time frame: From pre-program participation (recalled baseline) to current status at enrollment (2024)

Secondary outcomes

  1. Program Benefits Score

    Composite score based on a 5-item questionnaire developed for this study, using a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree), Range: 1-5. Interpretation: Higher scores indicate greater perceived program benefits (better outcome).

    Time frame: At enrolment (2024)

  2. Self-Confidence and Skill Development Score

    Composite score based on a 6-item questionnaire developed for this study, using a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Range: 1-5. Interpretation: Higher scores indicate greater self-confidence and skill development (better outcome).

    Time frame: At enrolment (2024)

  3. Facilitation and Partnerships Score

    Composite score based on a 4-item questionnaire developed for this study, using a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Range: 1-5. Interpretation: Higher scores indicate stronger program facilitation and organizational support (better outcome).

    Time frame: At enrolment (2024)

  4. Basic Needs and Economic Resilience Score

    Composite score based on a 5-item questionnaire developed for this study, using a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Range: 1-5. Interpretation: Higher scores indicate greater ability to meet household needs and manage financial shocks (better outcome).

    Time frame: At enrolment (2024)

  5. Future Intentions Score

    Composite score based on a 3-item questionnaire developed for this study, using a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Range: 1-5. Interpretation: Higher scores indicate stronger plans for sustaining or expanding program participation and work opportunities (better outcome).

    Time frame: At enrolment (2024).

  6. Perceived Barriers Score

    Composite score based on a 6-item questionnaire developed for this study, using a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree). Range: 1-5. Interpretation: Higher scores indicate greater perceived barriers (worse outcome).

    Time frame: At enrolment (2024).

Other outcomes

  1. Qualitative Themes on Health and Wellness Description: Semi-structured interviews with 10 participants exploring perceived effects of program participation on nutrition, stress reduction, preventive care, and psychosoc

    Semi-structured interviews with 10 participants exploring perceived effects of program participation on nutrition, stress reduction, preventive care, and psychosocial well-being. Thematic analysis used to identify and interpret themes.

    Time frame: At enrolment (2024).

07

Study locations

1 site
  • Angeles University Foundation
    Angeles City, Pampanga 2010, Philippines
08

References and documents

Publications

  • Braun V, Clarke V. Thematic analysis: A practical guide. London: Sage Publications; 2022.
  • Baker P, Smith JP, Garde A, Grummer-Strawn LM, Wood B, Sen G, Hastings G, Perez-Escamilla R, Ling CY, Rollins N, McCoy D; 2023 Lancet Breastfeeding Series Group. The political economy of infant and young child feeding: confronting corporate power, overcoming structural barriers, and accelerating progress. Lancet. 2023 Feb 11;401(10375):503-524. doi: 10.1016/S0140-6736(22)01933-X. Epub 2023 Feb 7. PubMed 36764315 ↗
  • Guliman EA, Uy JH. Financial decision-making and women's empowerment: Evidence from rural livelihood programs in the Philippines. Asian Women. 2021;37(3):67-88. doi:10.14431/aw.2021.09.37.3.67.

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared publicly due to the small sample size and the potential risk of re-identification of indigenous Aeta participants. Only aggregate data used in the results publication will be available. De-identified datasets may be shared upon reasonable request to the principal investigator, subject to institutional and ethical approval.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2024 to primary completion in Sep 2024, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2025
First posted
Sep 16, 2025
StartActual
Aug 1, 2024
Primary completionActual
Sep 15, 2024
CompletionActual
Dec 5, 2024
Last update
Sep 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07175064
Lead sponsor
Angeles University Foundation
Responsible party
Rudena A. Madayag (Assistant Professor, Angeles University Foundation) — Principal investigator
First posted
Sep 16, 2025
Start date
Aug 1, 2024
Primary completion
Sep 15, 2024
Completion
Dec 5, 2024
Last update
Sep 16, 2025

Study contacts

Rudena A Madayag, MAN
principal investigator · Angeles University Foundation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion