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L'essai clinique NCT06244888 pour Surpoids et obésité est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Control Systems Engineering for Weight Loss Maintenance
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'essai' pour voir et discuter des informations sur l'essai dans la langue sélectionnée.
L'essai clinique NCT06244888 est conçu pour étudier le treatment de Surpoids et obésité. Il s'agit d'un essai interventionnel en Phase II. Son statut actuel est : en recrutement. L'essai a débuté le 26 février 2024 et vise à recruter 180 participants. Dirigé par The Miriam Hospital, l'essai devrait être terminé d'ici le 31 décembre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 avril 2024.
Résumé succinct
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.
Titre officiel
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
Conditions
Surpoids et obésitéAutres identifiants de l'essai
Numéro NCT
Date de début (réel)
2024-02-26
Dernière mise à jour publiée
2024-04-02
Date de fin (estimée)
2027-12-31
Inscription (estimée)
180
Type d'essai
Interventionnel
PHASE
Phase II
Statut
En recrutement
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalSystem Identification All participants who lose at least 3% of their initial body weight will be asked to participate in a system identification experiment every day for 52 weeks. | Intervention Targeting Stress and Emotion Regulation This intervention involves learning and practicing relaxation exercises and setting aside time for pleasurable activities. 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. 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. 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. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Weight change | This will be measured throughout the system identification experiment using a consumer scale with internet connectivity. | Every day during the 52-week system identification experiment |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Intervention engagement | Intervention engagement will be measured by the smartphone application that delivers intervention. Engagement is defined as the count of clicks to open intervention resources. | Every day during the 52-week system identification experiment |
Weight Locus of Control | Mean scale score of questionnaire items adapted from the Multidimensional Health Locus of Control scale for smartphone administration. | Every day during the 52-week system identification experiment |
Perceived Benefit of Weight Control | Mean scale score of questionnaire items adapted from the Beliefs about Dietary Compliance Scale and the Exercise Benefits/Barriers scale for smartphone administration. | Every day during the 52-week system identification experiment |
Weight Control Strategies Intentions and Implementation | Mean scale score of questionnaire items adapted from the Weight Control Strategies scale for smartphone administration. | Every day during the 52-week system identification experiment |
Hunger and Cravings | Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration. | Every day during the 52-week system identification experiment |
Affect | Mean scale score of questionnaire items adapted from the Profile of Mood States and Positive and Negative Affect States for smartphone administration. | Every day during the 52-week system identification experiment |
Stress | Mean scale score of questionnaire items adapted from Cohen's Stress Scale for smartphone administration. | Every day during the 52-week system identification experiment |
Self-efficacy | Mean scale score of questionnaire items adapted from the short-form Weight Efficacy Lifestyle Questionnaire for smartphone administration. | Every day during the 52-week system identification experiment |
Sleep | Wrist-worn accelerometer-measured sleep timing, duration \& quality. | Every day during the 52-week system identification experiment |
Social Support | Mean scale score of questionnaire items adapted from the short-form Multidimensional Scale of Perceived Social Support for smartphone administration. | Every day during the 52-week system identification experiment |
Physical Activity | Wrist-worn accelerometer-measured minutes per day of physical activity. | Every day during the 52-week system identification experiment |
Dysregulated Eating | Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration. | Every day during the 52-week system identification experiment |
Dietary Lapse | Count of self-reported instances of unintended eating, eating larger portions than one intended, and eating foods that one intended to avoid | Every day during the 52-week system identification experiment |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- 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
- 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
The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Contact central de l'essai
Contact: Sharon O'Toole, M.A.T., 401 793-8992, [email protected]
1 Centres de l'essai dans 1 pays
Rhode Island
Miriam Hospital Weight Control and Diabetes Resarch Center, Providence, Rhode Island, 02903, United States
Sharon O'Toole, M.A.T., Contact, 401-793-8992, [email protected]
En recrutement