Control Systems Engineering for Weight Loss Maintenance

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Intervention Targeting Stress and Emotion Regulation
  This intervention involves learning and practicing relaxation exercises and setting aside time for pleasurable activities.
• Поведенческое Intervention Targeting Motivation and Self-efficacy for Weight Management
  This intervention involves identifying values related to weight, lifestyle, and health; identifying barriers to value-consistent living; exploring the consequences of letting barriers drive behavior; and 4) setting goals that are small, specific, attainable, and values-consistent.
• Поведенческое Intervention for Normalization of Eating
  This intervention involves dietary self-monitoring with the goal of staying within a calorie goal ranging from 1,200 kcal/day to 1,800 kcal/day. Participants are also provided with meal planning tools and encouraged to addresses hunger and cravings by promoting feelings of satiety via consumption of foods that are high in volume but low in calories.
• Поведенческое Intervention Targeting Physical Activity and Sleep
  This simple intervention prompts participants at the start of the day to schedule up to 30 minutes of moderate-to-vigorous intensity physical activity; brisk walking is encouraged. Participants also set a bedtime and wake time and are encouraged to set a reminder alarm to ensure at least 8 hours of sleep.

Первичные конечные точки

• Weight change [Срок оценки: Every day during the 52-week system identification experiment]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Miriam Hospital Weight Control and Diabetes Resarch Center — Providence

Идентификаторы

NCT: NCT06244888 · 422620 · 1R01DK137423

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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