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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Noelia Belando, PR (principal research)
- 전화번호: 620514995
- 이메일: belandonoelia@uniovi.es
연구 장소
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Principality of Asturias
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Oviedo, Principality of Asturias, 스페인, 33005
- University of Oviedo, Faculty of Teacher Education and Education, Oviedo, Asturias, Spain
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연락하다:
- Noelia Belando, PhD.
- 전화번호: 620514995
- 이메일: belandonoelia@uniovi.es
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부수사관:
- Irene Barbero Alcocer
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부수사관:
- Ángel Ballester Sánchez, Personal trainner
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부수사관:
- Guillermo Peña García-Orea, PhD.
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Lower-Limb Strength
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Body Composition (Fat, Muscle, and Bone Mass)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Number of Exercise Sessions Attended
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Noelia Belando, PhD., Universidad de Oviedo
간행물 및 유용한 링크
일반 간행물
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연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- WIA-2026-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .