- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Ayla Rezvan Reha, PhD
- Telefonnummer: +905340571233
- E-post: aylarezvanreha@aydin.edu.tr
Studiesteder
-
-
Avcilar
-
Istanbul, Avcilar, Tyrkia (Türkiye)
- Rekruttering
- Online
-
Ta kontakt med:
- Navid Reha, PhD
- Telefonnummer: +905350223304
- E-post: navidrha@yahoo.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Ventelistekontroll
|
|
|
Eksperimentell: ACT-Based Physical Literacy Program
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
|
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)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
|
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)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
|
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)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
|
Change From Baseline in Waist Circumference
Tidsramme: Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Baseline, Week 7 (post-core/pre-booster), and Week 11 (4-week post-booster follow-up)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026/08
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .