- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07817849
Online Acceptance and Commitment Therapy-Based Physical Literacy Program for Socioeconomically Disadvantaged Women Living With Overweight
Effects of a Brief Online Acceptance and Commitment Therapy-Based Physical Literacy Program in Socioeconomically Disadvantaged Women Living With Overweight: A Randomized Controlled Trial
This two-group, parallel, individually randomized controlled trial will evaluate a brief, live, online Acceptance and Commitment Therapy (ACT)-based physical literacy program among 60 socioeconomically disadvantaged adult women living with overweight. Participants will be randomized in a 1:1 ratio to either the intervention group or a waitlist control group.
The intervention consists of six weekly approximately 60-minute online group sessions integrating the six ACT processes with adult physical literacy education, guided movement, and graded home-based exercise snacks, followed by an independent-practice week and an approximately 60-minute booster session. Assessments will be conducted at baseline, immediately before the booster following completion of the six core sessions, and at post-booster follow-up. The study will compare changes between the intervention and waitlist control groups over the study period.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ayla Rezvan Reha, PhD
- Numéro de téléphone: +905340571233
- E-mail: aylarezvanreha@aydin.edu.tr
Lieux d'étude
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Avcilar
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Istanbul, Avcilar, Turquie (Türkiye)
- Recrutement
- Online
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Contact:
- Navid Reha, PhD
- Numéro de téléphone: +905350223304
- E-mail: navidrha@yahoo.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Eligibility required: (a) age 18 to 64 years old; (b) residence in Gümüşpala, Avcılar, Istanbul; (c) BMI of 25.0-29.9 kg/m²; (d) annual equivalized net disposable household income below TRY 144,690, the 60%-of-median threshold in the 2025 Turkish Statistical Institute poverty statistics, based on the 2024 income reference period (Turkish Statistical Institute, 2025); (e) no completion of high school (ISCED Levels 0-2; UNESCO Institute for Statistics, 2012); (f) ability to read and understand Turkish; (g) access to a smartphone, WhatsApp, and the internet; (h) willingness to complete all assessments; and (i) written informed consent.
Exclusion Criteria:
- pregnancy or childbirth within the previous six months; a medical or musculoskeletal condition, or professional advice, precluding or substantially restricting physical activity; concurrent participation in another structured weight-management, physical-activity, or psychological intervention; a cognitive or psychiatric condition substantially limiting comprehension or informed consent; or inability to complete study assessments.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Contrôle des listes d'attente
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Expérimental: ACT-Based Physical Literacy Program
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Participants receive the live online ACT-based physical literacy program consisting of six weekly approximately 60-minute group sessions, an independent-practice week, and an approximately 60-minute booster session.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Change From Baseline in Physical Literacy Scale for Adults (PLAS) Total Score
Délai: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Change From Baseline in PERMA-Profiler Overall Well-Being Score
Délai: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Change From Baseline in Psy-Flex Scale Score
Délai: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Change From Baseline in Total Physical Activity Measured by the Global Physical Activity Questionnaire (GPAQ)
Délai: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Change From Baseline in Body Mass Index (BMI)
Délai: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Change From Baseline in Waist Circumference
Délai: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026/08
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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