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Effect of A Theory-based Multicomponent eHealth Intervention Program

11 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Hui-Chuan Huang, PhD
  • Numéro de téléphone: 6349 8869872711878
  • E-mail: huichuan@tmu.edu.tw

Lieux d'étude

  • Viêt Nam
    • Thai Nguyen
      • Phan Dinh Phung Ward, Thai Nguyen, Viêt Nam, 250000
        • Phan Dinh Phung Ward Health center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: Mobile app weight self-stigma program
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.
Aucune intervention: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Body weight
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Eating behavior
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Taipei Medical University

Les enquêteurs

  • Chercheur principal: Hui-Chuan Huang, Ph.D, School of Nursing, College of Nursing, Taipei Medical University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

29 novembre 2026

Achèvement de l'étude (Estimé)

15 décembre 2026

Dates d'inscription aux études

Première soumission

6 juin 2026

Première soumission répondant aux critères de contrôle qualité

11 juin 2026

Première publication (Réel)

12 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • N202604142
  • D432112014 (Autre identifiant: Taipei Medical University)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared with other researchers, and there is no approved data-sharing plan at this time.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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