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L'essai clinique NCT06151145 pour 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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Université Johns-HopkinsStepped Care for Weight Loss Maintenance
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L'étude clinique NCT06151145 est un essai interventionnel pour Obésité. Son statut actuel est : en recrutement. L'étude a débuté le 1 février 2024 et vise à recruter 180 participants. Dirigé par l'Université Johns-Hopkins, l'essai devrait être terminé d'ici le 1 juin 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 8 mai 2025.
Résumé succinct
This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss.
16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet.
52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups:
- Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss.
- Participants in the SELF group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance.
- Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step.
Titre officiel
Stepped Care for Weight Loss Maintenance
Conditions
ObésitéAutres identifiants de l'essai
- IRB00404188
- R01NR020197 (Subvention/contrat NIH (É.-U.))
Numéro NCT
Date de début (réel)
2024-02-01
Dernière mise à jour publiée
2025-05-08
Date de fin (estimée)
2028-06
Inscription (estimée)
180
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
obesity
weight loss
weight loss
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifUsual care Usual care | Soins habituels Participants in usual care will be emailed monthly educational modules with information on maintaining weight loss. |
ExpérimentalText-message intervention with digital tools (SELF) Text-message intervention | SELF The SELF group will receive a wireless "smart" body weight scale and wearable physical activity tracker, and text messages. |
ExpérimentalStepped Care (STEP) Stepped care | STEP The STEP intervention consists of 4 steps that are progressive and based on response to treatment. Step 1: Digital health intervention. The first step will be the digital health intervention as described under SELF. Step 2: Monthly, in-person counseling. Participants who move to Step 2 will be provided with monthly, in-person counseling. Step 3: Twice per month counseling. Step 3 will be twice-monthly counseling, spaced at every other week. Step 4: Meal replacements. Participants will be prescribed a partial meal replacement program. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Weight (kg) change for STEP versus usual care | Weight change (kg) for STEP versus usual care | Baseline, 52 weeks |
Weight (kg) change for SELF versus usual care | Weight change (kg) for SELF versus usual care | Baseline, 52 weeks |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in self-weighing frequency (days) for STEP and SELF versus usual care | Change in number of days of self-weighing for STEP and SELF versus usual care | Baseline, 52 weeks |
Change in daily calorie intake for STEP and SELF vs usual care | Change in daily calorie intake measured using 24-hour dietary recalls for STEP and SELF versus usual care | Baseline, 52 weeks |
Change in physical activity (minutes) for STEP and SELF versus usual care | Change in self-reported minutes of physical activity for STEP and SELF versus usual care | Baseline, 52 weeks |
Weight (kg) change for STEP versus SELF | Weight change (kg) for STEP versus SELF | Baseline, 52 weeks |
Change in days of self-weighing for STEP versus SELF | Self-weighing frequency for STEP versus SELF | Baseline, 52 weeks |
Change in daily calorie intake for STEP versus SELF | Change in daily calorie intake measured using 24-hour dietary recalls for STEP versus SELF | Baseline, 52 weeks |
Change in self-reported minutes of Physical activity for STEP versus SELF | Change in self-reported minutes of physical activity for STEP versus SELF | Baseline, 52 weeks |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- BMI>/=30 kg/m2 or >/=27 kg/m2 with an obesity-related complication
- Age 18-70 years
- Completion of baseline assessment tasks
- Ability to engage in physical activity
- Own a smartphone capable of receiving text-messages and syncing to weight scales and physical activity trackers
- Home wireless access
- Serious medical condition or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the behavioral recommendations of the program
- Pregnant or planning pregnancy in the next 1.5 years
- Weight>440 lbs
- Planned move out of the area in the next 1.5 years
- Recently began a course of or changed the dosage of medication that can cause significant change in weight
- History of bariatric surgery
- Weight loss of >5% in the previous 6 months
- Household member already participating in study
Université Johns-Hopkins587 essais cliniques actifs à explorerNational Institute of Nursing Research (NINR)Contact central de l'essai
Contact: Ariana M Chao, PhD, CRNP, 4432876223, [email protected]
1 Centres de l'essai dans 1 pays
Maryland
Johns Hopkins University, Baltimore, Maryland, 21205, United States
Camille Siberine, Contact, 667-306-9366, [email protected]
En recrutement