Effect of A Theory-based Multicomponent eHealth Intervention Program
2026年6月11日 更新者：Huang, Hui-Chuan、Taipei Medical University
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.
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hang T.L. Do, MD
- 電話番号：84989886742
- メール：d432112014@tmu.edu.tw
研究連絡先のバックアップ
- 名前：Hui-Chuan Huang, PhD
- 電話番号：6349 8869872711878
- メール：huichuan@tmu.edu.tw
研究場所
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Thai Nguyen
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Phan Dinh Phung Ward、Thai Nguyen、ベトナム、250000
- Phan Dinh Phung Ward Health center
-
コンタクト：
- Le Hang T Do, MD
- 電話番号：84989886742
- メール：d432112014@tmu.edu.tw
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
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介入なし：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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body weight
時間枠：T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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Body weight will be measured using a digital body composition scale (Tanita BC-545N) Unit of measure: kilograms (kg)
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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|
Body Mass Index
時間枠：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 |
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
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Waist circumference
時間枠：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) |
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Body composition - Body fat percentage
時間枠：T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Body fat percentage will be assessed using a digital bioelectrical impedance body composition analyzer (Tanita BC-545N) Unit of Measure: Percentage (%)
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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Body composition - Body water percentage
時間枠：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 (%) |
T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
|
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Body composition - Muscle mass
時間枠：T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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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.
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Body composition - Visceral fat
時間枠：T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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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.
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Weight Self-Stigma
時間枠：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.
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Eating behavior
時間枠：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.
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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Physical Activity
時間枠：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
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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Health-related quality of life
時間枠：T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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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.
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T0: baseline/randomization; T1: immediately post-intervention; T2: 1 month post-intervention; T3: 3 months post-intervention
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Hui-Chuan Huang, Ph.D、School of Nursing, College of Nursing, Taipei Medical University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2026年11月29日
研究の完了 (推定)
2026年12月15日
試験登録日
最初に提出
2026年6月6日
QC基準を満たした最初の提出物
2026年6月11日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12日
QC基準を満たした最後の更新が送信されました
2026年6月11日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- N202604142
- D432112014 (その他の識別子：Taipei Medical University)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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