跳至主要内容
临床试验/NCT06244888
NCT06244888招募中2 期

Control Systems Engineering to Address the Problem of Weight Loss Maintenance: A System Identification Experiment to Model Behavioral & Psychosocial Factors Measured by Ecological Momentary Assessment

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年2月26日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
入组人数
180
试验地点
2
主要终点
Weight change

研究概览

简要总结

This project capitalizes on principles of control systems engineering to build a dynamical model that predicts weight change during weight loss maintenance using behavioral, psychosocial, and environmental indicators evaluated in a system identification experiment. A 6-month behavioral obesity treatment will be administered to produce weight loss. Participants losing at least 3% of initial body weight will be followed for an additional 12 months via daily smartphone surveys that incorporates passive sensing to objectively monitor key behaviors. Survey data pertaining to behavioral, psychosocial, and environmental indicators will be used to develop a controller algorithm that can predict when an individual is entering a heightened period of risk for regain and why risk is elevated. Interventions targeting key risk indicators will be randomly administered during the system ID experiment. Survey and passive sensing data documenting the effects of the interventions will likewise drive development of the controller algorithm, allowing it to determine which interventions are most likely to counter risk of regain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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) between 25 and 50 kg/m-squared
  • Able to walk 2 city blocks without stopping
  • Owns a smartphone

排除标准

  • Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling.
  • Currently participating in another weight loss program
  • Currently taking weight loss medication
  • Has lost ≥5% of body weight in the 6 months prior to enrolling
  • Has been pregnant within the 6 months prior to enrolling
  • Plans to become pregnant within 18 months of enrolling
  • Any medical condition that would affect the safety of participating in unsupervised physical activity
  • Any condition that would result in inability to follow the study protocol, including terminal illness and untreated major psychiatric illness

结局指标

主要结局

Weight change

时间窗: Every day during the 52-week system identification experiment

This will be measured throughout the system identification experiment using a consumer scale with internet connectivity.

次要结局

  • Weight Locus of Control(Every day during the 52-week system identification experiment)
  • Affect(Every day during the 52-week system identification experiment)
  • Self-efficacy(Every day during the 52-week system identification experiment)
  • Intervention engagement(Every day during the 52-week system identification experiment)
  • Weight Control Strategies Intentions and Implementation(Every day during the 52-week system identification experiment)
  • Dysregulated Eating(Every day during the 52-week system identification experiment)
  • Sleep(Every day during the 52-week system identification experiment)
  • Perceived Benefit of Weight Control(Every day during the 52-week system identification experiment)
  • Hunger and Cravings(Every day during the 52-week system identification experiment)
  • Stress(Every day during the 52-week system identification experiment)
  • Social Support(Every day during the 52-week system identification experiment)
  • Physical Activity(Every day during the 52-week system identification experiment)
  • Dietary Lapse(Every day during the 52-week system identification experiment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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