Effect of A Theory-based Multicomponent eHealth Intervention Program
11. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Hang T.L. Do, MD
- Telefonní číslo: 84989886742
- E-mail: d432112014@tmu.edu.tw
Studijní záloha kontaktů
- Jméno: Hui-Chuan Huang, PhD
- Telefonní číslo: 6349 8869872711878
- E-mail: huichuan@tmu.edu.tw
Studijní místa
-
-
Thai Nguyen
-
Phan Dinh Phung Ward, Thai Nguyen, Vietnam, 250000
- Phan Dinh Phung Ward Health center
-
Kontakt:
- Le Hang T Do, MD
- Telefonní číslo: 84989886742
- E-mail: d432112014@tmu.edu.tw
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Žádný zásah: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Body weight
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
|
Body weight will be measured using a digital body composition scale (Tanita BC-545N) Unit of measure: kilograms (kg)
|
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
|
|
Body Mass Index
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
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.
|
|
Waist circumference
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
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.
|
|
Body composition - Body fat percentage
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
Body fat 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.
|
|
Body composition - Body water percentage
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
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.
|
|
Body composition - Muscle mass
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
Muscle mass will be assessed using a digital bioelectrical impedance body composition analyzer (Tanita BC-545N) Unit of Measure: kilograms (kg)
|
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
|
Body composition - Visceral fat
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
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.
|
|
Weight Self-Stigma
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
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.
|
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Eating behavior
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
|
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.
|
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
|
|
Physical Activity
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
|
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
|
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
|
|
Health-related quality of life
Časové okno: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
|
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.
|
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Hui-Chuan Huang, Ph.D, School of Nursing, College of Nursing, Taipei Medical University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. července 2026
Primární dokončení (Odhadovaný)
29. listopadu 2026
Dokončení studie (Odhadovaný)
15. prosince 2026
Termíny zápisu do studia
První předloženo
6. června 2026
První předloženo, které splnilo kritéria kontroly kvality
11. června 2026
První zveřejněno (Aktuální)
12. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
11. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- N202604142
- D432112014 (Jiný identifikátor: Taipei Medical University)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Individual participant data will not be shared with other researchers, and there is no approved data-sharing plan at this time.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .