Effect of A Theory-based Multicomponent eHealth Intervention Program

NCT07644143 | Not Yet Recruiting

• 2 other identifiers: N202604142D432112014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight , Obesity

Keywords

eHealth; Weight Self-Stigma; Obesity; Overweight; Quality of Life

Outcome Measures

Primary Outcomes (8)

• Body weight

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

  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

  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)

  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 (%)

  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 (%)

  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)

  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

  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.

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

Secondary Outcomes (3)

• Eating behavior

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

• Physical Activity

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

• Health-related quality of life

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

Study Arms (2)

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.

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

Interventions

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.

Mapp-WSSP intervention group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Phan Dinh Phung Ward Health center

Phan Dinh Phung Ward, Thai Nguyen, 250000, Vietnam

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Hui-Chuan Huang, Ph.D

  School of Nursing, College of Nursing, Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hang T.L. Do, MD

CONTACT

84989886742; d432112014@tmu.edu.tw

Hui-Chuan Huang, PhD

CONTACT

8869872711878; huichuan@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None / Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Nursing

Model Details: Participants will be randomized to participate in the Mapp-WSSP intervention group or a waitlist.

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 29, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)