Reset: Enhancing Weight Loss in a Digital Intervention

Официальное название

Enhancing Weight Loss in a Digital Intervention Among Adults With Overweight or Obesity

Обзор

The goal of the Reset trial is to learn about the optimal combination of dietary behavior strategies in a fully digital weight loss intervention. The intervention is designed for adults with overweight or obesity. The investigators will examine the impact on weight loss of four dietary strategies: 1) limiting Red Zone Foods (i.e., foods that are high in calories and low in nutrition), 2) limiting eating windows, 3) increasing protein intake, and 4) increasing fiber intake. Each of these strategies will include goal setting, daily self-monitoring, and tailored feedback. The investigators will recruit 208 participants. Broadly, adults with overweight or obesity who live in the U.S. will be eligible. The weight loss intervention will last 12 weeks. All participants will be asked to track their body weight daily and complete weekly behavioral lessons and action plans to promote healthy eating and physical activity. All study tasks will occur remotely. Assessment of body weight and survey measures will occur at the beginning of the trial ("baseline"), and at 1 month and 3 months. The Multiphase Optimization Strategy (MOST) framework will be used to identify which combination of the dietary behavior strategies results in the greatest weight loss. In total, there will be 16 treatment conditions.

Вмешательства

• Поведенческое Core Behavioral Weight Loss Intervention
  All participants receive a 12-week core behavioral weight loss intervention consisting of the following: daily self-monitoring of weight; weekly behavioral lessons and action plans to promote healthy eating and physical activity; and tailored feedback. The intervention will be delivered remotely via email and/or text message.
• Поведенческое Limit Red Zone Foods
  Participants randomized to receive this component are given a goal to limit their Red Zone Foods (i.e., foods high in calories and low in nutrition) and are instructed to self-monitor them daily.
• Поведенческое Limit Eating Window
  Participants randomized to receive this component are given a goal to limit their eating windows (i.e., follow time-restricted eating) and are instructed to self-monitor them daily.
• Поведенческое Increase Protein
  Participants randomized to receive this component are given a goal to increase their protein intake and are instructed to self-monitor it daily.
• Поведенческое Increase Fiber Intake
  Participants randomized to receive this component are given a goal to increase their fiber intake and are instructed to self-monitor it daily.

Первичные конечные точки

• Weight Change from Baseline to 3 Months [Срок оценки: Baseline and 3 Months]

Вторичные конечные точки (4)

• Weight Change from Baseline to 1 Month [Срок оценки: Baseline and 1 Month]
• Clinically Significant Weight Loss at 3 Months [Срок оценки: 3 Months]
• Moderate-to-Vigorous Physical Activity (MVPA) Change from Baseline to 3 Months [Срок оценки: Baseline and 3 Months]
• Caloric Intake Change from Baseline to 3 Months [Срок оценки: Baseline and 3 Months]

Критерии участия

Критерии включения

• adults (ages 18+ years)
• body mass index (BMI) 25.0 to 45.0 kg/m\^2
• cellphone ownership with a texting plan
• daily access to a personal scale
• daily access to a personal email account
• English language proficiency
• interest in losing weight through behavioral strategies
• living in the United States

Критерии исключения

• concurrent enrollment in another weight management intervention
• loss of ≥5% body weight in the past 6 months
• current use of a weight loss or anti-obesity medication
• prior or planned bariatric surgery in the next 3 months
• current pregnancy, planned pregnancy in the next 3 months, or recent pregnancy in the past 6 months
• current breastfeeding or lactating
• living with someone else participating in the study
• hospitalization for a mental health condition in the past 12 months
• inability to engage in moderate forms of physical activity akin to brisk walking
• if weight loss is contraindicated or might be impacted by a condition (e.g., end stage renal disease, cancer, schizophrenia, dementia) or medication (e.g., steroids, antipsychotics)
• if an individual would be better suited for a more intensive or different type of intervention based on a health condition (e.g., individuals with history of an eating disorder or cardiovascular event, uncontrolled hypertension, or uncontrolled diabetes mellitus)
• participation in another weight loss study conducted in Dr. Patel's lab in the past 6 months
• investigator discretion for safety reasons

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stanford University School of Medicine — Palo Alto

Идентификаторы

NCT: NCT07032571 · 81144

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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