Overweight , ObesityNCT07644143
Effect of A Theory-based Multicomponent eHealth Intervention Program
A study testing Mobile app weight self-stigma program in people with Overweight , Obesity, run by Taipei Medical University at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Overweight , Obesity
- What is being tested?
- Mobile app weight self-stigma program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jul 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site
Phan Dinh Phung Ward Health center
Phan Dinh Phung Ward, Thai Nguyen, 250000
Le Hang T Do, MD, 84989886742, d432112014@tmu.edu.tw
About this study
Official 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
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.
Read more
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.
- Conditions
- Overweight , Obesity
- Being tested
- Mobile app weight self-stigma program
- Keywords
- eHealth, Weight Self-Stigma, Obesity, Overweight, Quality of Life
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app weight self-stigma programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mapp-WSSP intervention group | Experimental | 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. Receives: Behavioral: Mobile app weight self-stigma program |
| Waitlist control group | No intervention | Participants will continue their daily activities until after 3 months, then will be allowed to install the mobile app on their smart phones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight will be measured using a digital body composition scale (Tanita BC-545N) Unit of measure: kilograms (kg)
Measured: 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
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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)
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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 (%)
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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 (%)
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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)
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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.
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
Secondary outcomes (3)
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.
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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.
Measured: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion29 Nov 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight , ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to participate in the Mapp-WSSP intervention group or a waitlist.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang, Hui-Chuan, Taipei Medical University
- Investigators
- Hui-Chuan Huang, Ph.D, Principal investigator, School of Nursing, College of Nursing, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644143
- Sponsor's protocol ID
- N202604142
- Other IDs
- D432112014
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers, and there is no approved data-sharing plan at this time.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07644143
- Acronym / sponsor ID
- N202604142
- Conditions
- Overweight , Obesity
- Keywords
- eHealth, Weight Self-Stigma, Obesity, Overweight, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 29 Nov 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to participate in the Mapp-WSSP intervention group or a waitlist.
| Arm | Type | Receives |
|---|---|---|
| Mapp-WSSP intervention group | Experimental | Behavioral: Mobile app weight self-stigma programThe 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. |
| Waitlist control group | No intervention | –Participants will continue their daily activities until after 3 months, then will be allowed to install the mobile app on their smart phones |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile app weight self-stigma programParticipants 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. | Behavioural | Mapp-WSSP intervention group |
Primary outcome
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)
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
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)
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 (%)
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 (%)
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)
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
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.
3 secondary outcomes
Eating behavior
Time frame: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
Physical Activity
Time frame: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
Health-related quality of life
Time frame: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers, and there is no approved data-sharing plan at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui-Chuan Huang, Ph.D principal investigator
School of Nursing, College of Nursing, Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app weight self-stigma program in people with Overweight , Obesity, run by Taipei Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hang T.L. Do, MD (84989886742, d432112014@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.