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临床试验/NCT07228130
NCT07228130招募中不适用

Microrandomized Trial to Optimize Use of Burden-reducing Self-monitoring Approaches in Behavioral Obesity Treatment

The Miriam Hospital1 个研究点 分布在 1 个国家目标入组 275 人开始时间: 2026年1月7日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
275
试验地点
1
主要终点
Adherence to Self-Monitoring

研究概览

简要总结

This clinical trial is focused on testing dietary self-monitoring strategies used in behavioral obesity treatment. The goal is to determine which self-monitoring strategies are most useful for whom, at which points in treatment, and under what circumstances.

Researchers will provide a 24-week online behavioral obesity treatment program, and will randomize participants to use one of 5 dietary self-monitoring strategies every two weeks. The five strategies include: recording all food and drink consumed and corresponding energy intake (i.e., "calories") on 7 days per week; recording all food and drink consumed and corresponding energy intake (i.e., "calories") on 3 days per week; self-monitoring of dietary lapses (i.e. any eating/drinking likely to cause weight gain or put weight loss at risk); smartwatch-based monitoring of energy intake (i.e., "calories"); and self-monitoring of body weight only via smart scale.

Participants will:

  • Follow a 24-week online program for weight loss and health improvement
  • Use the assigned self-monitoring strategy every two weeks
  • Meet with the researchers periodically via online video call and provide research data by answering questions via periodic online surveys.

详细描述

This clinical trial is a 24-week micro-randomized trial (MRT) designed to optimize the use of dietary self-monitoring (SM) strategies during behavioral obesity treatment (BOT). Self-monitoring is considered the cornerstone of BOT because it enables individuals to regulate behaviors that influence energy balance and weight loss. However, adherence to traditional full dietary SM (i.e., recording all food and beverages consumed each day) declines rapidly over time due to its burden, leading to poorer weight loss outcomes.

To address this problem, this study evaluates five SM approaches that vary in intensity and burden:

  1. Full dietary SM: Recording all food and drink consumed, with calorie estimates, every day.
  2. Reduced-frequency dietary SM: Recording all food and drink consumed, with calorie estimates, on 3 days per week.
  3. Self-monitoring of dietary lapses only: Recording only episodes of eating or drinking that likely cause weight gain or put weight loss at risk.
  4. Smartwatch-based SM of energy intake: Using a smartwatch that detects eating gestures and estimates energy intake (i.e., "calories") via built-in sensors.
  5. Body weight SM only: Weighing daily using a smart scale that automatically syncs data to the online treatment platform.

All participants (N=275 adults with overweight or obesity, aged 18-70) will receive a 24-week evidence-based, online BOT. This BOT includes interactive multimedia lessons on nutrition, physical activity, and behavioral skills for weight management, with individualized calorie and activity goals, self-regulation training, and automated feedback. The only experimental manipulation is the self-monitoring approach assigned every two weeks.

At the start of treatment and every two weeks thereafter, participants will be randomly assigned to one of the five SM approaches (12 total randomizations per participant). Randomization probabilities favor assignment to full dietary SM at treatment initiation, then gradually equalize across approaches. At each randomization, participants will be notified of their new SM assignment and receive a brief online training for that approach. A member of the research team will conduct a short online video call to confirm comprehension and assist with troubleshooting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English language fluent and literate at the 6th grade level
  • Body mass index (BMI) above 25 kg/m-squared
  • Able to walk 2 city blocks without stopping
  • Not currently participating in another weight loss program
  • Not currently taking weight loss medication
  • Has not lost ≥5% of body weight in the 6 months prior to enrolling
  • Has not been pregnant within the 6 months prior to enrolling
  • Does not plan to become pregnant within 12 months of enrolling
  • Denies having a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
  • Denies any medical condition that would affect the safety of participating in unsupervised physical activity
  • Denies any condition that would result in inability to follow the study protocol, including terminal illness, substance abuse, eating disorder (not including Binge Eating Disorder) and untreated major psychiatric illness
  • Owns a smartphone compatible with study procedures and is willing to use it for study participation

排除标准

  • 未提供

研究组 & 干预措施

Online Behavioral Obesity Treatment with Full Dietary Self-monitoring

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Full Dietary Self-monitoring intervention.

干预措施: Online Behavioral Obesity Treatment (Behavioral)

Online Behavioral Obesity Treatment with Full Dietary Self-monitoring

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Full Dietary Self-monitoring intervention.

干预措施: Full Dietary Self-monitoring (Behavioral)

Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Reduced-frequency Dietary Self-monitoring intervention.

干预措施: Online Behavioral Obesity Treatment (Behavioral)

Online Behavioral Obesity Treatment with Reduced-frequency Dietary Self-monitoring

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Reduced-frequency Dietary Self-monitoring intervention.

干预措施: Reduced-frequency Dietary Self-monitoring (Behavioral)

Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Self-Monitoring of Dietary Lapses Only intervention.

干预措施: Online Behavioral Obesity Treatment (Behavioral)

Online Behavioral Obesity Treatment with Self-Monitoring of Dietary Lapses Only

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Self-Monitoring of Dietary Lapses Only intervention.

干预措施: Self-Monitoring of Dietary Lapses Only (Behavioral)

Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Smartwatch-based Self-monitoring of Energy Intake intervention.

干预措施: Online Behavioral Obesity Treatment (Behavioral)

Online Behavioral Obesity Treatment with Smartwatch-based Self-monitoring of Energy Intake

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Smartwatch-based Self-monitoring of Energy Intake intervention.

干预措施: Smartwatch-based Self-monitoring of Energy Intake (Behavioral)

Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Self-monitoring of Body Weight Only intervention.

干预措施: Online Behavioral Obesity Treatment (Behavioral)

Online Behavioral Obesity Treatment with Self-monitoring of Body Weight Only

Experimental

The Online Behavioral Obesity Treatment intervention combined with the Self-monitoring of Body Weight Only intervention.

干预措施: Self-monitoring of Body Weight Only (Behavioral)

结局指标

主要结局

Adherence to Self-Monitoring

时间窗: 24 weeks

Number of days on which the assigned self-monitoring strategy was used

Weight Change

时间窗: 24 weeks

Weight measured in kg on the provided home scale

次要结局

  • Perceived Burden of Assigned Self-Monitoring Approach(24 weeks)
  • Motivation to Engage in Self-Monitoring(24 weeks)
  • Satisfaction With Assigned Self-Monitoring Approach(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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