- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ayla Rezvan Reha, PhD
- 전화번호: +905340571233
- 이메일: aylarezvanreha@aydin.edu.tr
연구 장소
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Avcilar
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Istanbul, Avcilar, 터키 (Türkiye)
- 모병
- Online
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연락하다:
- Navid Reha, PhD
- 전화번호: +905350223304
- 이메일: navidrha@yahoo.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 대기자 명단 제어
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Change From Baseline in Physical Literacy Scale for Adults (PLAS) Total Score
기간: 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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2차 결과 측정
결과 측정 |
기간 |
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Change From Baseline in PERMA-Profiler Overall Well-Being Score
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .