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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Noelia Belando, PR (principal research)
- 電話番号：620514995
- メール：belandonoelia@uniovi.es
研究場所
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Principality of Asturias
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Oviedo、Principality of Asturias、スペイン、33005
- University of Oviedo, Faculty of Teacher Education and Education, Oviedo, Asturias, Spain
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コンタクト：
- Noelia Belando, PhD.
- 電話番号：620514995
- メール：belandonoelia@uniovi.es
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副調査官：
- Irene Barbero Alcocer
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副調査官：
- Ángel Ballester Sánchez, Personal trainner
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副調査官：
- Guillermo Peña García-Orea, PhD.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Lower-Limb Strength
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in Body Composition (Fat, Muscle, and Bone Mass)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Number of Exercise Sessions Attended
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Noelia Belando, PhD.、Universidad de Oviedo
出版物と役立つリンク
一般刊行物
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研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- WIA-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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