Women in Action: A Multicomponent Intervention for Older Women (WIA)
October 1, 2026 updated by: Noelia Belando Belando, Universidad de Oviedo
"Women in Action": A Multicomponent Gender-Sensitive Intervention Combining Nutrition, Psychosocial Factors, and Strength Training in Perimenopausal, Menopausal, and Early-Aging Women-A Quasi-Experimental Study Protocol
"Women in Action" is a quasi-experimental, mixed-methods study evaluating a 16-week multicomponent intervention (supervised strength/aerobic/balance training plus psychoeducational and nutrition-focused behavioral workshops) for women aged 55-75 in perimenopause, menopause, and early ageing. The study will assess the feasibility, implementation fidelity, and acceptability of the program, together with its preliminary effects on a single primary outcome (handgrip strength) and secondary physical function, dietary, and psychosocial outcomes, compared with a passive control group receiving no intervention.
Study Overview
Status
Status
Not yet recruiting
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Participants will be allocated to an Intervention or Control group using a non-random, minimization-based procedure balancing key baseline characteristics (age, menopausal status, physical activity level, physical function, gender-related stereotype internalization, socioeconomic status, geographical context). The Intervention group receives supervised strength, aerobic, and balance training (2 sessions/week, 50-60 min, 16 weeks) plus 8 biweekly psychoeducational and nutrition-focused workshops (90 min each). Assessments occur at baseline (T0), mid-intervention (T1, week 8), post-intervention (T2, week 16), and 3-month follow-up (T3). The primary outcome is handgrip strength (T0 to T2 change). Secondary outcomes include the Short Physical Performance Battery, body composition (bioelectrical impedance analysis), Mediterranean diet adherence (MEDAS), a 3-day dietary record (energy and protein intake), and validated psychosocial instruments (personal agency/empowerment, physical self-concept, ageing- and exercise-related stereotypes, exercise self-efficacy). A qualitative strand (focus groups at T2 and T3) is integrated using a convergent parallel mixed-methods design. The primary analysis will use linear mixed-effects models under an intention-to-treat framework.
Study Type
Study Type
Interventional
Enrollment (Estimated)
Enrollment
214
Phase
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
Study Contact
- Name: Noelia Belando, PR (principal research)
- Phone Number: 620514995
- Email: belandonoelia@uniovi.es
Study Locations
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Principality of Asturias
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Oviedo, Principality of Asturias, Spain, 33005
- University of Oviedo, Faculty of Teacher Education and Education, Oviedo, Asturias, Spain
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Contact:
- Noelia Belando, PhD.
- Phone Number: 620514995
- Email: belandonoelia@uniovi.es
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Sub-Investigator:
- Irene Barbero Alcocer
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Sub-Investigator:
- Ángel Ballester Sánchez, Personal trainner
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Sub-Investigator:
- Guillermo Peña García-Orea, PhD.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
55 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Aged 55-75 years
- Residing in the Principality of Asturias, Spain
- Written informed consent
- Medical clearance for supervised moderate-to-vigorous physical activity
- Suboptimal physical activity level (not meeting WHO recommendations of ≥150 min/week moderate or ≥75 min/week vigorous aerobic activity and/or <2 muscle-strengthening sessions/week, and/or low adherence to prior exercise routines), screened via the Global Physical Activity Questionnaire (GPAQ)
- Relevant exposure to gender-related stereotypes associated with physical activity
- Willingness to complete all assessment phases (T0-T3)
Exclusion Criteria:
- Medical conditions contraindicating supervised exercise
- Severe cognitive impairment limiting program participation
- Concurrent involvement in structured resistance-training interventions
- Any physical or functional condition precluding safe execution of physical performance assessments (handgrip strength, SPPB)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
2
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Multicomponent
Participants receive the 16-week "Women in Action" multicomponent program: supervised strength, aerobic, and balance training (2 sessions/week, 50-60 min/session) plus 8 biweekly psychoeducational and nutrition-focused behavioral workshops (90 min each; 4 nutrition-focused, 4 psychoeducational). Optional, separately consented co-educational workshops involving men are offered as an additional module. |
16-week program combining supervised resistance, aerobic, and balance training with psychoeducational and nutrition-focused behavioral workshops, delivered by qualified exercise professionals, psychologists, and nutrition professionals. |
|
No Intervention: No multicomponent
Participants maintain their usual lifestyle habits with no intervention exposure during the study period and receive basic intervention-related information after study completion. |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Lower-Limb Strength
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
|
Standing-up and sitting-down test (number of repetitions of standing up and sitting down from a chair in 30 seconds). |
1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
|
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Change in Handgrip Strength
Time Frame: Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Hand grip strength: Assessed using a manual (hand) dynamometer (kg). |
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Body Composition (Fat, Muscle, and Bone Mass)
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
|
Assessed via bioelectrical impedance analysis (BIA), using a validated, standardized, field-applicable device. Measures: body mass (body fat, muscle mass, and bone mass in kg) |
1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Change in Basal Metabolic Rate
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Basal metabolic rate in kcal. |
1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Change in Body Mass Index (BMI)
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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BMI in kg/m² |
1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Change in Mediterranean Diet Adherence Score
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Measured by the Mediterranean Diet Adherence Screener (MEDAS): score from 1 to 14. Scoring method: Some items are scored as "more than once a day" (equivalent to 1 point), and other items are scored as "three or more times a day/week" (equivalent to 1 point). |
1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
|
|
Change in Personal Agency and Empowerment Score
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
|
Measured by the Spanish Validated Scale of Personal Agency and Empowerment (ESAGE-Sp-19). Responses are collected using a Likert-type scale. A Likert scale consisting of 19 items organized into the following factors: Personal Agency, Self-Confidence, Internal Control, and Empowerment. There are 5 response options ranging from 0 (never) to 4 (always). The total score is the arithmetic mean. |
1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Change in Physical Self-Concept Score
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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CAF-MAY score. 30-item Physical Self-Concept Questionnaire for Older Adults (CAF-MAY), which measures the subject's perception of the following dimensions of the personal self: physical ability (6 items), physical appearance (6 items), health/illness (6 items), functional ability (6 items), and general physical self-concept (6 items). The test is formatted as a Likert scale with 5 response options: strongly disagree (1) to strongly agree (5). The total score is the arithmetic mean. |
1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Change in Ageing- and Exercise-Related Stereotypes Score
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Measured by the Ageing Stereotypes and Exercise Scale (ASES). The ASES is a self-report measure assessing stereotypes about aging in the context of exercise and physical activity. The questionnaire consists of 15 items scored on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores are obtained by summing item responses and range from 15 to 75, with higher scores indicating more positive stereotypes regarding aging and exercise (more favorable beliefs about older adults' ability to engage in and benefit from exercise) and lower scores indicating more negative stereotypes and greater perceived barriers to exercise among older adults. |
1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Change in Exercise Self-Efficacy Score
Time Frame: 1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Self-Efficacy for Exercise Scale, SEE score. The Self-Efficacy for Exercise Scale is a self-report measure of an individual's confidence in their ability to engage in regular exercise under a variety of challenging conditions. The scale consists of 9 items, each rated on an 11-point scale ranging from 0 (Not Confident) to 10 (Very Confident). Total scores are calculated by summing all item responses and range from 0 to 90, with higher scores indicating greater self-efficacy for exercise (better outcome) and lower scores indicating lower confidence in the ability to maintain regular exercise (worse outcome). |
1) baseline assessment (pre-intervention): week 0; 2) intermediate assessment: week 8; 3) post-intervention assessment: week 16; 4) follow-up evaluation (3 months after the intervention ended).
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Number of Exercise Sessions Attended
Time Frame: 1) intermediate assessment: week 8 and 2) post-intervention assessment: week 16; 3) follow-up evaluation (3 months after the intervention ended: Participants will be asked, via a Microsoft Forms questionnaire, how many weekly exercise session).
|
Number of weekly exercise sessions attended by each participant out of the total sessions offered, self-reported via a Microsoft Forms questionnaire. |
1) intermediate assessment: week 8 and 2) post-intervention assessment: week 16; 3) follow-up evaluation (3 months after the intervention ended: Participants will be asked, via a Microsoft Forms questionnaire, how many weekly exercise session).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Noelia Belando, PhD., Universidad de Oviedo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
Study Start
November 1, 2026
Primary Completion (Estimated)
Primary Completion
December 1, 2027
Study Completion (Estimated)
Study Completion
June 1, 2028
Study Registration Dates
First Submitted
First Submitted
August 27, 2026
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
October 1, 2026
First Posted (Actual)
First Posted
October 6, 2026
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
October 6, 2026
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
October 1, 2026
Last Verified
Last Verified
October 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Sarcopenia
- Sedentary Behavior
- Health Behavior
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Population Characteristics
- Health Status
- Demography
- Nutritional Status
Other Study ID Numbers
Other Study ID Numbers
- WIA-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
If individual-level data will not be shared beyond aggregate results, consistent with GDPR-compliant handling of participant data); confirm this choice with the University of Oviedo's data protection officer before submission.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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