- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04023318
The BMI Project (Body, Mind, Inflammation)
A Novel Integrated Lifestyle Intervention to Reduce Obesity and Inflammation Among Emerging Adults
Obesity and chronic inflammation influence the development and progression of many types of cancer. These conditions share several of the same causes, including physical inactivity, poor nutrition, stress, and insufficient sleep. Emerging adulthood (ages 18-25) represents an important developmental period in which to address behaviors and psychological variables that affect both weight status and inflammation. At least 40% of emerging adults have overweight/obesity, and this transition from adolescence to early adulthood is associated with significant increases in fast food consumption, decreases in physical activity, unpredictable sleep schedules, and alarmingly high rates of depression and perceived stress.
Despite this high risk for obesity, very few weight loss interventions are designed specifically for emerging adults. Preliminary findings from weight loss interventions targeting this population have shown some promise, but generally produce modest outcomes with less consistent effects than programs in older adults. Depression and stress have been found to interfere with weight loss among emerging adults, and may be in part responsible for poorer outcomes. This proposal will develop and test an Integrated Lifestyle Intervention (ILI) that comprehensively addresses both psychological distress and traditional weight management targets. This novel approach has not been tested before and has the potential not only to enhance weight loss outcomes in this high risk population, but also to produce reductions in markers of inflammation beyond those achievable by weight loss alone.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Virginia
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Richmond, Virginia, États-Unis, 23219
- Virginia Commonwealth University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age between 18 and 25 years
- Body Mass Index between 25 and 45 kg/m2
Exclusion Criteria:
- Currently pregnant or lactating; pregnancy in the last 6 months or plans to become pregnant in the next 6 months
- Type 1 or type 2 diabetes
- Any uncontrolled medical conditions that could make it unsafe to participate in unsupervised exercise
- Medical conditions associated with chronic inflammation
- Inability to read, understand and speak English
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Integrated Lifestyle Intervention
|
This program is grounded in data demonstrating the dysregulation across multiple domains and considerable life stressors experienced by this population.
The central hypothesis is that by simultaneously ameliorating psychological dysregulation and directly targeting proinflammatory behaviors, ILI operates on multiple proposed mediators of poor treatment outcomes in this population, thereby enhancing treatment outcomes.
As such, the overall framework emphasizes integration of self-regulation as it applies to both psychological functioning and weight control.
Content will highlight the interconnectedness of mood, stress, eating and exercise behaviors, and risk for inflammation and disease.
Each treatment session will present a combination of behavioral and psychological content, representing a truly integrated approach.
Participants will meet for 75-minute group sessions weekly for months 1-2, followed by bi-weekly groups in months 3-4, for a total of 12 groups.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of sessions attended throughout the intervention period
Délai: 4 months
|
Attendance at in-person treatment sessions is one critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
|
4 months
|
Number of days self-monitoring weight in LoseIt
Délai: 4 months
|
Self-monitoring of weight is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
|
4 months
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Number of days self-monitoring weight-related behaviors in LoseIt
Délai: 4 months
|
Self-monitoring of weight-related behaviors (e.g., diet and physical activity) is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
|
4 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in diet
Délai: Baseline and 4 months
|
Dietary change will be assessed using the Diet History Questionnaire III (DHQ-III), a 166-item adaptive questionnaire developed by NCI which maps on to dietary intervention targets (e.g., saturated fat, alcohol, sugar, fiber, sodium), as well as a measure of overall diet.
|
Baseline and 4 months
|
Change in physical activity
Délai: Baseline and 4 months
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Participants will report their physical activity using the 6-item Paffenbarger Physical Activity Questionnaire, which yields estimates of minutes spent in moderate-to-vigorous physical activity.
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Baseline and 4 months
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Change in sleep
Délai: Baseline and 4 months
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The EARLY Trials Common Elements Sleep Questionnaire (8 items) will be administered that asks about duration of sleep and problems encountered during sleep (e.g.
snoring).
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Baseline and 4 months
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Percent Weight Change
Délai: Baseline and 4 months
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Weight will be measured in light clothes, without shoes, on calibrated Tanita BWB-800S scales.
Percent change of initial body weight will be calculated using baseline and 4 month weights.
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Baseline and 4 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jessica LaRose, PhD, Virginia Commonwealth University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MCC-18-14509
- HM20015075 (Autre identifiant: Virginia Commonwealth University IRB)
- NCI-2019-04792 (Autre identifiant: National Cancer Institute)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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