Women in Action: A Multicomponent Intervention for Older Women (WIA)
"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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Noelia Belando, PR (principal research)
- Telefonní číslo: 620514995
- E-mail: belandonoelia@uniovi.es
Studijní místa
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Principality of Asturias
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Oviedo, Principality of Asturias, Španělsko, 33005
- University of Oviedo, Faculty of Teacher Education and Education, Oviedo, Asturias, Spain
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Kontakt:
- Noelia Belando, PhD.
- Telefonní číslo: 620514995
- E-mail: belandonoelia@uniovi.es
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Dílčí vyšetřovatel:
- Irene Barbero Alcocer
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Dílčí vyšetřovatel:
- Ángel Ballester Sánchez, Personal trainner
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Dílčí vyšetřovatel:
- Guillermo Peña García-Orea, PhD.
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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. |
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Žádný zásah: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Lower-Limb Strength
Časové okno: 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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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
Časové okno: 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).
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Body Composition (Fat, Muscle, and Bone Mass)
Časové okno: 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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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
Časové okno: 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)
Časové okno: 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
Časové okno: 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).
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Change in Personal Agency and Empowerment Score
Časové okno: 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 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Number of Exercise Sessions Attended
Časové okno: 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).
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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).
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Noelia Belando, PhD., Universidad de Oviedo
Publikace a užitečné odkazy
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Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Nemoci nervového systému
- Neuromuskulární projevy
- Patologické stavy, anatomické
- Svalová atrofie
- Atrofie
- Patologické stavy, příznaky a symptomy
- Chování
- Příznaky a symptomy
- Sarkopenie
- Sedavé chování
- Zdravotní chování
- Strava, jídlo a výživa
- Fyziologické jevy
- Nutriční fyziologické jevy
- Charakteristiky populace
- Zdravotní stav
- Demografie
- Nutriční stav
Další identifikační čísla studie
- WIA-2026-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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