Effect of A Theory-based Multicomponent eHealth Intervention Program
11 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Hang T.L. Do, MD
- Telefonnummer: 84989886742
- E-post: d432112014@tmu.edu.tw
Studera Kontakt Backup
- Namn: Hui-Chuan Huang, PhD
- Telefonnummer: 6349 8869872711878
- E-post: huichuan@tmu.edu.tw
Studieorter
-
-
Thai Nguyen
-
Phan Dinh Phung Ward, Thai Nguyen, Vietnam, 250000
- Phan Dinh Phung Ward Health center
-
Kontakt:
- Le Hang T Do, MD
- Telefonnummer: 84989886742
- E-post: d432112014@tmu.edu.tw
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Body weight
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
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Body composition - Body water percentage
Tidsram: 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
Tidsram: 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.
|
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Body composition - Visceral fat
Tidsram: 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.
|
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Weight Self-Stigma
Tidsram: 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.
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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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Eating behavior
Tidsram: 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.
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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
Tidsram: 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
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Health-related quality of life
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Hui-Chuan Huang, Ph.D, School of Nursing, College of Nursing, Taipei Medical University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
29 november 2026
Avslutad studie (Beräknad)
15 december 2026
Studieregistreringsdatum
Först inskickad
6 juni 2026
Först inskickad som uppfyllde QC-kriterierna
11 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- N202604142
- D432112014 (Annan identifierare: Taipei Medical University)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will not be shared with other researchers, and there is no approved data-sharing plan at this time.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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