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NCT Number: NCT07644143

Effect of A Theory-based Multicomponent eHealth Intervention Program

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.

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Key information

Conditions

Overweight , Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phan Dinh Phung Ward Health center

Phan Dinh Phung Ward, Thai Nguyen, 250000, Vietnam

Location contact

Le Hang T Do, MD

CONTACT

[email protected]

84989886742

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Body weight

    Time frame: 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)

  2. Body Mass Index

    Time frame: 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

  3. Waist circumference

    Time frame: 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)

  4. Body composition - Body fat percentage

    Time frame: 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 (%)

  5. Body composition - Body water percentage

    Time frame: 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 (%)

  6. Body composition - Muscle mass

    Time frame: 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)

  7. Body composition - Visceral fat

    Time frame: 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

  8. Weight Self-Stigma

    Time frame: 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.

Secondary outcomes

  1. Eating behavior

    Time frame: 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.

  2. Physical Activity

    Time frame: 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

  3. Health-related quality of life

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hang T.L. Do, MD

CONTACT

[email protected]

84989886742

Hui-Chuan Huang, PhD

CONTACT

[email protected]

8869872711878 ext. 6349

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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