Effect of A Theory-based Multicomponent eHealth Intervention Program
2026년 6월 11일 업데이트: Huang, Hui-Chuan, Taipei Medical University
Effect Of A Theory-Based Multicomponent Ehealth Intervention On Weight Self - Stigma, Bodyweight And Quality Of Life Among Overweight And Obese Adults: A Pilot Randomized Controlled Trial
This study is a two-arm pilot randomized controlled trial designed to evaluate the feasibility and preliminary effects of an Acceptance and Commitment Therapy (ACT) theory-based mobile application integrated with a smartphone pedometer plus health education on weight self-stigma and lifestyle behaviors among overweight or obese adults.
A total of 60 participants will be recruited and randomized 1:1 to the intervention (ACT-based app + pedometer + health education) or control condition. Outcomes will be assessed at baseline (T0), immediately after intervention (T1), and at 1 month after intervention (T2) and 3 months after intervention (T3) following intervention initiation. The primary outcomes are body weight (weight loss) and weight self-stigma measured; secondary outcomes include eating behavior, physical activity level, and quality of life.
Analyses will include per-protocol evaluation using linear mixed-effects models to test group, time, and group-by-time effects on primary and secondary outcomes, with intention-to-treat analyses conducted as sensitivity analyses using multiple imputation for missing weight and weight self-stigma data.
Findings will inform the design of a future definitive trial and contribute evidence on eHealth approaches to reducing weight-related stigma and supporting healthier lifestyles.
연구 개요
상세 설명
Participants will be recruited through flyers, physician referrals, and advertisements in local media outlets and on Facebook.
Participants will be screened for eligibility via telephone interviews and in-person conducted by trained researchers, using predefined inclusion and exclusion criteria.
Participants will be randomized to participate in the Mapp-WSSP intervention group or a waitlist.
The MappWSSP intervention group will receive the "mobile app- weight self-stigma program" consisting of 1) a mobile app lifestyle and weight self-stigma intervention 2) a smartphone app to monitor the steps and 3) deliver a total of eight workshops over four weeks, focusing on diet and weight self-stigma reduction practices.
Waitlist control group participants will continue their daily activities until after 3 months, then will be allowed to install the mobile app on their iPhones.
Outcome assessment visits occurred at baseline/randomization, immediately after intervention, 1 month, and 3 months after intervention at the community health center.
at the community health center.
Participants may withdraw from the study at any time without penalty.
To ensure data integrity, all study data will undergo double data entry and verification.
Collected information will be coded (de-identified) and stored securely.
Data quality will be monitored monthly.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Hang T.L. Do, MD
- 전화번호: 84989886742
- 이메일: d432112014@tmu.edu.tw
연구 연락처 백업
- 이름: Hui-Chuan Huang, PhD
- 전화번호: 6349 8869872711878
- 이메일: huichuan@tmu.edu.tw
연구 장소
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Thai Nguyen
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Phan Dinh Phung Ward, Thai Nguyen, 베트남, 250000
- Phan Dinh Phung Ward Health center
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연락하다:
- Le Hang T Do, MD
- 전화번호: 84989886742
- 이메일: d432112014@tmu.edu.tw
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Aged 18 to 55 years
- Body mass index (BMI) ≥23 kg/m²
- Weight self-stigma, defined as a Weight Self-Stigma Questionnaire (WSSQ) score >36
- Owns or has regular access to a smartphone
- Resides in Phan Dinh Phung municipality, Thai Nguyen Province, Vietnam
- Able to read and write in Vietnamese
Exclusion Criteria:
- Type 1 or type 2 diabetes
- Uncontrolled hypertension, defined as blood pressure ≥160/100 mmHg
- Cardiovascular event, such as stroke or myocardial infarction, within the past year
- Weight loss of ≥5% of initial body weight in the past 3 months or ≥10% in the past 2 years
- Participation in a weight-loss program within the past 3 months
- Cognitive impairment, including a diagnosis of dementia
- Psychiatric condition, including major depression or generalized anxiety disorder
- Current use of weight-loss medication
- History of bariatric surgery
- Unable to perform physical activity
- Engages in ≥150 minutes of structured physical activity per week or >75 minutes of high-intensity exercise per week
- Pregnant or planning pregnancy within the next 6 months
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Mapp-WSSP intervention group
The Mapp-WSSP intervention group will receive the "mobile app- weight self-stigma program" consisting of 1) a mobile app lifestyle and weight self-stigma intervention 2) a smartphone app to monitor the steps and 3) deliver a total of eight workshops over four weeks, focusing on diet and weight self-stigma reduction practices.
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Participants assigned to the Mapp-WSSP group will receive a mobile app-based lifestyle and weight self-stigma reduction program.
The intervention includes: 1) a mobile app providing lifestyle and weight self-stigma intervention content; 2) a smartphone app for step monitoring; and 3) eight workshops delivered over four weeks focusing on diet-related practices and strategies to reduce weight self-stigma.
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간섭 없음: Waitlist control group
Participants will continue their daily activities until after 3 months, then will be allowed to install the mobile app on their smart phones
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body weight
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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Body weight will be measured using a digital body composition scale (Tanita BC-545N) Unit of measure: kilograms (kg)
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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Body Mass Index
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Height will be measured using the height measurement. Body weight will be measured using a digital scale (Tanita BC 545N). Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared. Unit of measure: kg/m² |
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Waist circumference
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Waist circumference will be measured in duplicate to the nearest 0.1 cm using a Gulick tape measure, with participants wearing lightweight clothing. Measurements will be taken horizontally at the level of the iliac crest, and the average of the two measurements will be used. Unit of measure: centimeters (cm) |
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Body composition - Body fat percentage
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Body fat percentage will be assessed using a digital bioelectrical impedance body composition analyzer (Tanita BC-545N) Unit of Measure: Percentage (%)
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Body composition - Body water percentage
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Body water percentage will be assessed using a digital bioelectrical impedance body composition analyzer (Tanita BC-545N). Unit of Measure: percentage (%) |
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Body composition - Muscle mass
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Muscle mass will be assessed using a digital bioelectrical impedance body composition analyzer (Tanita BC-545N) Unit of Measure: kilograms (kg)
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Body composition - Visceral fat
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Visceral fat rating will be measured using a digital bioelectrical impedance body composition analyzer (Tanita BC-545N). Unit of Measure: Tanita visceral fat rating score |
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Weight Self-Stigma
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Weight Self-Stigma Questionnaire (WSSQ) developed by Lillis et al. (2010) will be used to measure weight self-stigma.
This questionnaire consists of two factors: self-devaluation and fear of enacted stigma, with a total of 12 items.
A Likert 5-point scale was employed, where 1 to 5 represent "strongly disagree" to "strongly agree."
Higher total scores indicate higher levels of weight self-stigma among participants.
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Eating behavior
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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The Mini-EAT (Mini Eating Assessment Tool) is a validated, 9-item dietary screener (Lara-Breitinger et al. 2023) will be used to measure eating behavior.
The total score is obtained by summing the individual item scores, with higher scores indicating better adherence to healthy dietary patterns.
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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Physical Activity
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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The International Physical Activity Questionnaire-Short Form (IPAQ-SF) is an 8-item scale (Tran et al. 2013) will be used to measure physical activity
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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Health-related quality of life
기간: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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Health-related quality of life will be measured using the 36-item Short Form Health Survey (SF-36).
The SF-36 assesses eight domains: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
Higher scores indicate better health-related quality of life.
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Hui-Chuan Huang, Ph.D, School of Nursing, College of Nursing, Taipei Medical University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2026년 11월 29일
연구 완료 (추정된)
2026년 12월 15일
연구 등록 날짜
최초 제출
2026년 6월 6일
QC 기준을 충족하는 최초 제출
2026년 6월 11일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 11일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- N202604142
- D432112014 (기타 식별자: Taipei Medical University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared with other researchers, and there is no approved data-sharing plan at this time.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .