Enhancing Weight Loss in a Digital Intervention Among Adults With Overweight or Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Weight Change from Baseline to 3 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes will be analyzed in a blinded fashion such that treatment allocation is not revealed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Condition 7
Core + Limit Eating Window + Increase Protein
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 8
Core + Limit Eating Window + Increase Protein + Increase Fiber
干预措施: Increase Protein (Behavioral)
Condition 10
Core + Limit Red Zone Foods + Increase Fiber
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 10
Core + Limit Red Zone Foods + Increase Fiber
干预措施: Limit Red Zone Foods (Behavioral)
Condition 14
Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber
干预措施: Limit Red Zone Foods (Behavioral)
Condition 1
Core Only
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 2
Core + Increase Fiber
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 3
Core + Increase Protein
干预措施: Increase Protein (Behavioral)
Condition 4
Core + Increase Protein + Increase Fiber
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 4
Core + Increase Protein + Increase Fiber
干预措施: Increase Protein (Behavioral)
Condition 4
Core + Increase Protein + Increase Fiber
干预措施: Increase Fiber Intake (Behavioral)
Condition 5
Core + Limit Eating Window
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 5
Core + Limit Eating Window
干预措施: Limit Eating Window (Behavioral)
Condition 15
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein
干预措施: Increase Protein (Behavioral)
Condition 15
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein
干预措施: Limit Eating Window (Behavioral)
Condition 2
Core + Increase Fiber
干预措施: Increase Fiber Intake (Behavioral)
Condition 3
Core + Increase Protein
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 6
Core + Limit Eating Window + Increase Fiber
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 7
Core + Limit Eating Window + Increase Protein
干预措施: Limit Eating Window (Behavioral)
Condition 7
Core + Limit Eating Window + Increase Protein
干预措施: Increase Protein (Behavioral)
Condition 11
Core + Limit Red Zone Foods + Increase Protein
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 8
Core + Limit Eating Window + Increase Protein + Increase Fiber
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 8
Core + Limit Eating Window + Increase Protein + Increase Fiber
干预措施: Limit Eating Window (Behavioral)
Condition 8
Core + Limit Eating Window + Increase Protein + Increase Fiber
干预措施: Increase Fiber Intake (Behavioral)
Condition 9
Core + Limit Red Zone Foods
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 11
Core + Limit Red Zone Foods + Increase Protein
干预措施: Limit Red Zone Foods (Behavioral)
Condition 9
Core + Limit Red Zone Foods
干预措施: Limit Red Zone Foods (Behavioral)
Condition 11
Core + Limit Red Zone Foods + Increase Protein
干预措施: Increase Protein (Behavioral)
Condition 12
Core + Limit Red Zone Foods + Increase Protein + Increase Fiber
干预措施: Increase Protein (Behavioral)
Condition 12
Core + Limit Red Zone Foods + Increase Protein + Increase Fiber
干预措施: Increase Fiber Intake (Behavioral)
Condition 12
Core + Limit Red Zone Foods + Increase Protein + Increase Fiber
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 12
Core + Limit Red Zone Foods + Increase Protein + Increase Fiber
干预措施: Limit Red Zone Foods (Behavioral)
Condition 13
Core + Limit Red Zone Foods + Limit Eating Window
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 13
Core + Limit Red Zone Foods + Limit Eating Window
干预措施: Limit Red Zone Foods (Behavioral)
Condition 13
Core + Limit Red Zone Foods + Limit Eating Window
干预措施: Limit Eating Window (Behavioral)
Condition 14
Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 14
Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber
干预措施: Limit Eating Window (Behavioral)
Condition 14
Core + Limit Red Zone Foods + Limit Eating Window + Increase Fiber
干预措施: Increase Fiber Intake (Behavioral)
Condition 15
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 15
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein
干预措施: Limit Red Zone Foods (Behavioral)
Condition 16
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber
干预措施: Core Behavioral Weight Loss Intervention (Behavioral)
Condition 16
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber
干预措施: Limit Red Zone Foods (Behavioral)
Condition 16
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber
干预措施: Limit Eating Window (Behavioral)
Condition 16
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber
干预措施: Increase Protein (Behavioral)
Condition 16
Core + Limit Red Zone Foods + Limit Eating Window + Increase Protein + Increase Fiber
干预措施: Increase Fiber Intake (Behavioral)
Condition 10
Core + Limit Red Zone Foods + Increase Fiber
干预措施: Increase Fiber Intake (Behavioral)
Condition 6
Core + Limit Eating Window + Increase Fiber
干预措施: Limit Eating Window (Behavioral)
Condition 6
Core + Limit Eating Window + Increase Fiber
干预措施: Increase Fiber Intake (Behavioral)
结局指标
主要结局
Weight Change from Baseline to 3 Months
时间窗: Baseline and 3 Months
mean change in kg; assessed via participants' personal scales
次要结局
- Weight Change from Baseline to 1 Month(Baseline and 1 Month)
- Clinically Significant Weight Loss at 3 Months(3 Months)
- Moderate-to-Vigorous Physical Activity (MVPA) Change from Baseline to 3 Months(Baseline and 3 Months)
- Caloric Intake Change from Baseline to 3 Months(Baseline and 3 Months)
研究者
Michele Patel
Principal Investigator
Stanford University