Cognitive Strategies for Weight Loss

Официальное название

Adapting Episodic Future Thinking for Behavioral Weight Loss: Comparing Strategies and Characterizing Treatment Response

Обзор

The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are: * Which of the three Internet-delivered weight loss programs results in the greatest weight loss? * How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms? * What individual characteristics predict success in each arm? * What are the underlying mechanisms of each approach? * Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns). Participants will: * signed informed consent * complete a baseline assessment * be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE * complete a training workshop to learn arm-specific cognitive strategies * complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons * complete an assessment at 3 months (during treatment) * complete a refresher workshop on arm-specific cognitive strategies at 3 months * complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment

Вмешательства

• Поведенческое Standard Behavioral Weight Loss Intervention
  12-month online behavioral weight loss intervention
• Поведенческое PREVENT Behavioral Weight Loss Intervention
  12-month online behavioral weight loss intervention focused on preventing future negative consequences of obesity
• Поведенческое PROMOTE Behavioral Weight Loss Intervention
  12-month online behavioral weight loss intervention focused on promoting future benefits of maintaining a healthy weight

Первичные конечные точки

• Percent Weight Change at 3 months [Срок оценки: 3 months after randomization]
• Percent Weight Change at 6 months [Срок оценки: 6 months after randomization]
• Percent Weight Change at 12 months [Срок оценки: 12 months after randomization]
• Percent Weight Change Post-Treatment [Срок оценки: 18 months after randomization]

Вторичные конечные точки (4)

• Change in Actigraph-measured Physical Activity (PA) [Срок оценки: 12 months after randomization]
• Change in Dietary Recall [Срок оценки: 12 months after randomization]
• Intervention Adherence - lessons viewed [Срок оценки: 12 months after randomization]
• Intervention Adherence - self-monitoring [Срок оценки: 12 months after randomization]

Критерии участия

Критерии включения

• Participants will be between the ages of 18 and 70, have a BMI between 25 and 45 kg/m2, and have regular (i.e., weekly) access to the Internet, defined as owning a smart phone with Internet capabilities, and/or having a broadband or Wi-Fi connection at home or work.

Критерии исключения

• Exclusionary criteria include: 1) current enrollment in a weight loss program, 2) currently taking weight loss medications, 3) history of bariatric surgery or planned bariatric surgery in the next 18 months, 4) individuals who are pregnant, nursing, or have plans to become pregnant within the next 18 months, 5) individuals planning to relocate outside the area in the next 18 months, 6) any medical condition for which weight loss would be contraindicated, 7) neurological or psychiatric conditions including but not limited to schizophrenia and bipolar disorder, 8) inability to attend assessments at the Weight Control and Diabetes Research Center in Providence, RI.

Individuals with mobility issues, dizziness, or history of heart disease, diabetes, or cancer will be required to provide physician consent prior to enrolling.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weight Control & Diabetes Research Center — Providence

Идентификаторы

NCT: NCT05799846 · 1809657-4 · R01DK128412

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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