Clinical trial

Effect of A Theory-based Multicomponent eHealth Intervention Program

Opening soon · Not applicable · 1 countries · Registry ID NCT07644143

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight , Obesity

Full registry criteria

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

Treatments and study arms

Mobile app weight self-stigma program

Behavioral

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.

Primary outcomes

Body weightT0: 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)

Body Mass IndexT0: 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

Waist circumferenceT0: 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)

Body composition - Body fat percentageT0: 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 (%)

Body composition - Body water percentageT0: 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 (%)

Body composition - Muscle massT0: 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)

Body composition - Visceral fatT0: 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

Weight Self-StigmaT0: 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.

Study locations

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Phan Dinh Phung Ward Health center🌐 Phan Dinh Phung Ward, Thai Nguyen, Vietnam

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Le Hang T Do, MDContact

Email · Call 84989886742