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Not yet recruitingNCT07644143Updated Jun 12, 2026

Effect of A Theory-based Multicomponent eHealth Intervention Program

An interventional study of Mobile app weight self-stigma program in Overweight , Obesity, sponsored by Taipei Medical University. Not yet recruiting at 1 site in Vietnam. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Overweight , Obesity

Keywords

  • eHealth
  • Weight Self-Stigma
  • Obesity
  • Overweight
  • Quality of Life
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 60 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Mobile app weight self-stigma program

  • No 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

Interventions

  • BehavioralMobile 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

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

  3. Waist circumference

    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)

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

  4. Body composition - Body fat percentage

    Body fat percentage will be assessed using a digital bioelectrical impedance body composition analyzer (Tanita BC-545N) Unit of Measure: Percentage (%)

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

  5. Body composition - Body water percentage

    Body water percentage will be assessed using a digital bioelectrical impedance body composition analyzer (Tanita BC-545N). Unit of Measure: percentage (%)

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

  6. Body composition - Muscle mass

    Muscle mass will be assessed using a digital bioelectrical impedance body composition analyzer (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.

  7. Body composition - Visceral fat

    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

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

  8. Weight Self-Stigma

    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.

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

Secondary outcomes

  1. Eating behavior

    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.

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

  2. Physical Activity

    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

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

  3. Health-related quality of life

    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.

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

07

Study locations

1 site
  • Phan Dinh Phung Ward Health center
    Phan Dinh Phung Ward, Thai Nguyen 250000, Vietnam
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared with other researchers, and there is no approved data-sharing plan at this time.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07644143
Lead sponsor
Taipei Medical University
Responsible party
Huang, Hui-Chuan (Professor, School of Nursing, Taipei Medical University) — Principal investigator
First posted
Jun 12, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Nov 29, 2026 (estimated)
Completion
Dec 15, 2026 (estimated)
Last update
Jun 12, 2026

Study contacts

Hang T.L. Do, MD
Contact
d432112014@tmu.edu.tw
84989886742
Hui-Chuan Huang, PhD
Contact
huichuan@tmu.edu.tw
8869872711878 ext. 6349
Hui-Chuan Huang, Ph.D
principal investigator · School of Nursing, College of Nursing, Taipei Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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