Women in Action: A Multicomponent Intervention for Older Women

ConditionsSarcopenia Physical Inactivity Menopause Healthy Aging

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age55-75

SponsorUniversidad de Oviedo

About this trial

"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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 55-75 years

Residing in the Principality of Asturias, Spain

Written informed consent

Medical clearance for supervised moderate-to-vigorous physical activity

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Multicomponent exercise, nutrition, and psychoeducational program
Behavioral
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.

Treatment groups

214 Participants

are divided into 2 treatment groups

Group A: MulticomponentExperimental treatment 1 intervention

Group B: No multicomponentNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in Lower-Limb Strength

Standing-up and sitting-down test (number of repetitions of standing up and sitting down from a chair in 30 seconds).

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).

Change in Handgrip Strength

Hand grip strength: Assessed using a manual (hand) dynamometer (kg).

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).

Secondary outcomes

Change in Body Composition (Fat, Muscle, and Bone Mass)

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)

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).

Change in Basal Metabolic Rate

Basal metabolic rate in kcal.

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).

Change in Body Mass Index (BMI)

BMI in kg/m²

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).

Change in Mediterranean Diet Adherence Score

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).

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).

Other outcomes

Change in Number of Exercise Sessions Attended

Number of weekly exercise sessions attended by each participant out of the total sessions offered, self-reported via a Microsoft Forms questionnaire.

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).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Oviedo

Lead sponsor

Instituto Politécnico de Castelo Branco

Collaborator

Source ClinicalTrials.gov

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