Effect of A Theory-based Multicomponent eHealth Intervention Program

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Mobile 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.

Первичные конечные точки

• Body weight [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention]
• Body Mass Index [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.]
• Waist circumference [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.]
• Body composition - Body fat percentage [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.]
• Body composition - Body water percentage [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.]
• Body composition - Muscle mass [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.]
• Body composition - Visceral fat [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.]
• Weight Self-Stigma [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.]

Вторичные конечные точки (3)

• Eating behavior [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention]
• Physical Activity [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention]
• Health-related quality of life [Срок оценки: T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• Phan Dinh Phung Ward Health center — Phan Dinh Phung Ward

Идентификаторы

NCT: NCT07644143 · N202604142 · D432112014

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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