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Simplifying Diet Tracking in a Digital Weight Loss Intervention

2026年5月22日 更新者：Michele Patel、Stanford University

Simplifying Dietary Self-Monitoring in a Digital Weight Loss Intervention

The purpose of this study is to compare two approaches for tracking dietary intake in a 12-month fully digital weight loss intervention: (1) Simplified approach: track Red Zone Foods (e.g., foods high in calories and low in nutritional value) vs. (2) Detailed approach: track all foods and their corresponding calories. In essence, this is a head-to-head comparison of two tracking approaches; the investigators are evaluating whether weight loss is comparable over 12 months, or whether one approach will have greater weight loss.

The investigators will recruit 328 adults. Broadly, adults with overweight or obesity who live in the United States will be eligible. The weight loss intervention will last 12 months. All participants will be asked to track their dietary intake + body weight + steps daily as well as 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, 6, 12, and 18 months.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

328

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • Palo Alto、California、美国、94304
        • Stanford University School of Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • adults (ages 18+ years)
  • body mass index (BMI) 25.0 to 45.0 kg/m^2
  • smartphone ownership
  • willing to install a mobile app on personal smartphone
  • access to a personal email account
  • English or Spanish language proficiency
  • interest in losing weight through behavioral strategies
  • living in the United States
  • willing to be randomized

Exclusion Criteria:

  • concurrent enrollment in another weight management intervention
  • loss of ≥5% weight in the past 6 months
  • prior or planned bariatric surgery during the trial period
  • current or planned pregnancy during the trial period, or recent pregnancy in the past 6 months
  • currently breastfeeding or lactating
  • current use of anti-obesity medications
  • 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
  • medical or psychiatric contraindication (e.g., end stage renal disease, cancer, schizophrenia, dementia, use of steroids, use of antipsychotic medication)
  • 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)
  • investigator discretion for safety reasons

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Simplified (Track Red Zone Foods)
Simplified + Core
行为的：Simplified Dietary Self-Monitoring
Participants randomized to receive this intervention are instructed to track their Red Zone Foods (i.e., foods high in calories and low in nutritional value) daily via a web-based checklist. Participants receive a daily Red Zone Food goal.
行为的：Core Behavioral Weight Loss Intervention
All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight & steps; 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.
实验性的：Detailed (Track All Foods/Calories)
Detailed + Core
行为的：Core Behavioral Weight Loss Intervention
All participants receive a 12-month core behavioral weight loss intervention consisting of the following: goal setting; daily self-monitoring of body weight & steps; 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.
行为的：Detailed Dietary Self-Monitoring
Participants randomized to receive this intervention are instructed to track all foods/drinks and their corresponding calories daily via a mobile app. Participants receive a daily calorie goal.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Weight Change from Baseline to 12 Months
大体时间：Baseline, 12 Months
mean change in body weight (kg); assessed objectively via e-scale using standardized procedures (e.g., place the scale on a hard surface; collect weight in the morning, without clothing, prior to eating/drinking)
Baseline, 12 Months

次要结果测量

结果测量
措施说明
大体时间
Weight Change from Baseline to 1 Month
大体时间：Baseline, 1 Month
mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
Baseline, 1 Month
Weight Change from Baseline to 6 Months
大体时间：Baseline, 6 Months
mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
Baseline, 6 Months
Weight Change from Baseline to 18 Months
大体时间：Baseline, 18 Months
mean change in body weight (kg); assessed objectively via e-scale using standardized procedures
Baseline, 18 Months
Caloric Intake Change from Baseline to 12 Months
大体时间：Baseline, 12 Months
mean change in daily caloric intake (kilocalories); assessed via the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24): 2 separate diet recalls per time point: 1 week day, 1 weekend day
Baseline, 12 Months
Diet Quality Change from Baseline to 12 Months
大体时间：Baseline, 12 Months
mean change in diet quality; assessed via the Healthy Eating Index, calculated from ASA24 data; score range: 0 to 100, with higher scores indicating better diet quality
Baseline, 12 Months
Step Count Change from Baseline to 12 Months
大体时间：Baseline, 12 Months
mean change in step count; assessed objectively via activity tracker
Baseline, 12 Months
Health-Related Quality of Life (Physical Health) Change from Baseline to 12 Months
大体时间：Baseline, 12 Months
mean change in health-related quality of life (Physical Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life
Baseline, 12 Months
Health-Related Quality of Life (Mental Health) Change from Baseline to 12 Months
大体时间：Baseline, 12 Months
mean change in health-related quality of life (Mental Component Summary); assessed via the SF-36 survey; score range: 0 to 100, with higher scores indicating better quality of life
Baseline, 12 Months
Engagement in Self-Monitoring Dietary Intake
大体时间：daily during the 12-month intervention
operationalized as average percentage of days in the 12-month intervention of self-monitoring dietary intake (Red Zone Foods for Simplified arm vs. all foods/calories for Detailed arm); assessed via e-checklist for Simplified arm and via app for Detailed arm; will report median (IQR) if data are non-normally distributed
daily during the 12-month intervention
Engagement in Self-Monitoring Weight
大体时间：daily during the 12-month intervention
operationalized as average percentage of days in the 12-month intervention of self-monitoring body weight; assessed via e-scale; will report median (IQR) if data are non-normally distributed
daily during the 12-month intervention
Engagement in Self-Monitoring Steps
大体时间：daily during the 12-month intervention
operationalized as average percentage of days in the 12-month intervention of self-monitoring steps; assessed via activity tracker; will report median (IQR) if data are non-normally distributed
daily during the 12-month intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stanford University

调查人员

  • 首席研究员：Michele L. Patel, PhD、Stanford University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年5月1日

初级完成 (估计的)

2030年4月30日

研究完成 (估计的)

2030年10月31日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月22日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 87051

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The de-identified dataset and metadata will be made available through a public repository. It will include the primary outcome (weight change), secondary outcomes, and participant level characteristics. Data will be available in an Excel spreadsheet, whereby each row corresponds to a unique participant's data, and columns represent the different variables mentioned, by time point.

IPD 共享时间框架

The shared dataset and metadata will be preserved and made publicly available to share for at least 3 years following completion of the project, in accordance with NIH regulations. They will be made available upon publication of the primary outcomes paper in a peer-reviewed journal, or at the end of the grant period (whichever comes first).

IPD 共享访问标准

Publicly available.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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