Effect of A Theory-based Multicomponent eHealth Intervention Program

N/ANot Yet RecruitingNCT07644143

Taipei Medical University60 enrolled

Overview

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.

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.

Study Type

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Body weight

Body weight will be measured using a digital body composition scale (Tanita BC-545N) Unit of measure: kilograms (kg)

Time frame: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention

Body Mass Index

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