- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ayla Rezvan Reha, PhD
- Telefonnummer: +905340571233
- E-mail: aylarezvanreha@aydin.edu.tr
Studiesteder
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Avcilar
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Istanbul, Avcilar, Tyrkiet (Türkiye)
- Rekruttering
- Online
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Kontakt:
- Navid Reha, PhD
- Telefonnummer: +905350223304
- E-mail: navidrha@yahoo.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Ventelistekontrol
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change From Baseline in Physical Literacy Scale for Adults (PLAS) Total Score
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change From Baseline in PERMA-Profiler Overall Well-Being Score
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026/08
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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