Nutrition DisordersMMSNCT07175064
Nursing-Led Livelihood Programs and Women's Health
An observational study of Nutrition Disorders and Stress, Psychological, run by Angeles University Foundation at 1 site in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition Disorders, Stress, Psychological, Mental Health Issue
- What is being tested?
- Nursing-Led Livelihood Programs
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Aug 2024to 5 Dec 2024
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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 informed consent
Who cannot join
- 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 informed consent
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Angeles University Foundation
Angeles City, Pampanga, 2010
About this study
Official title: Nursing-Led Livelihood Programs and Women's Health: Advancing Sustainable Development Goals on Poverty, Good Health and Well-Being, and Decent Work Among Indigenous Aeta in the Philippines
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).
- Being tested
- Nursing-Led Livelihood Programs
- Keywords
- Community Health Nursing, Women's Health, Indigenous Peoples, Philippines, Empowerment
- Medical subject headings
- Nutrition Disorders, Stress, Psychological, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing-Led Livelihood ProgramsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nursing-Led Livelihood Programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (pre-program, recalled) and at enrollment (current, 2024)
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.
Measured: From pre-program participation (recalled baseline) to current status at enrollment (2024)
Secondary outcomes (6)
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).
Measured: At enrolment (2024)
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).
Measured: At enrolment (2024)
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).
Measured: At enrolment (2024)
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).
Measured: At enrolment (2024)
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).
Measured: At enrolment (2024).
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).
Measured: At enrolment (2024).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Aug 2024
- Primary completion15 Sep 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nutrition DisordersStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angeles University Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rudena A. Madayag, Angeles University Foundation
- Investigators
- Rudena A Madayag, MAN, Principal investigator, Angeles University Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175064
- Sponsor's protocol ID
- 2024-CON-Faculty-006
- Acronym
- MMS
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 36764315Guliman 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing-Led Livelihood Programs and Women's Health: Advancing Sustainable Development Goals on Poverty, Good Health and Well-Being, and Decent Work Among Indigenous Aeta in the Philippines
- ClinicalTrials.gov ID
- NCT07175064
- Acronym / sponsor ID
- MMS / 2024-CON-Faculty-006
- Keywords
- Community Health Nursing, Women's Health, Indigenous Peoples, Philippines, Empowerment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Angeles University FoundationUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 16 Sep 2025 (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.
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.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Livelihood Program Participants | – | Behavioral: Nursing-Led Livelihood ProgramsAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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 informed consent
Key exclusion criteria (3 listed)
- 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 informed consent
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 |
|---|---|---|
| Nursing-Led Livelihood ProgramsA 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. | Behavioural | Livelihood Program Participants |
Primary outcome
Household Income Change
Time frame: (pre-program, recalled) and at enrollment (current, 2024)
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.
Employment Status Shift
Time frame: From pre-program participation (recalled baseline) to current status at enrollment (2024)
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.
6 secondary outcomes
Program Benefits Score
Time frame: At enrolment (2024)
Self-Confidence and Skill Development Score
Time frame: At enrolment (2024)
Facilitation and Partnerships Score
Time frame: At enrolment (2024)
Basic Needs and Economic Resilience Score
Time frame: At enrolment (2024)
Future Intentions Score
Time frame: At enrolment (2024).
Perceived Barriers Score
Time frame: At enrolment (2024).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- BackgroundBraun V, Clarke V. Thematic analysis: A practical guide. London: Sage Publications; 2022.
- Background: PubMed 36764315Baker 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.
- BackgroundGuliman 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 dataSharing planned: 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.
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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.
Rudena A Madayag, MAN principal investigator
Angeles University Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Disorders and Stress, Psychological, run by Angeles University Foundation at 1 site in Philippines.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 16 Sep 2025. 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 Philippines. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Household Income Change (time frame: (pre-program, recalled) and at enrollment (current, 2024)). 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 NCT07175064, which also lists 3 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 16 Sep 2025.