Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program" (GLBOMEX)
20 mai 2016 mis à jour par: Rolando Giovanni Díaz Zavala, Universidad de Sonora
Translational Study for Overweight and Obesity Management in Adults Using the "Group Lifestyle Balance Program" in Primary Care Clinics and Public Hospitals From Sonora, México
Obesity is the main modifiable risk factor for the development of chronic diseases in Mexico.
Several randomized controlled trials have shown that intensive lifestyle programs are efficacious for the management of obesity.
These programs include frequent sessions (14 or more contacts in the first 6 months) focused on diet and physical activity and use a behavior change protocol.
In Mexico most primary care clinics and public hospitals apply traditional treatments for obesity management, which have limited effect on weight loss.
This study would provide scientific evidence for an effective model for obesity management.
Objective.
The purpose of this study is to evaluate the effectiveness of the "Group Lifestyle Balance Program" for overweight and obesity management in adults, in primary care clinics and public hospitals from Sonora.
This is a translational clinical study.
Healthcare providers from the participating clinics will be trained with the Group Lifestyle Balance Program before its implementation.
The primary outcome measurement is the change in body weight from baseline to 6 months and 12 months.
Changes in body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life and stress scales will be measured in patients receiving the program before and 6 and 12 months after starting the program.
Additionally, biochemical parameters (fasting glucose, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, fasting insulin, Homeostatic Model Assessment- Insulin Resistance (HOMA-IR) and liver enzymes [Aspartate transaminase (AST), Alanine Aminotransferase (ALT)] will be evaluated from baseline to 12 months.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
258
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Sonora
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Hermosillo, Sonora, Mexique, 83000
- Centro de Promoción de Salud Nutricional (CPSN)
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Hermosillo, Sonora, Mexique, 83000
- Centro de Salud Urbano Dr. Domingo Olivares
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Hermosillo, Sonora, Mexique, 83000
- Hospital General del Estado de Sonora
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Hermosillo, Sonora, Mexique, 83000
- Hospital Ignacio Chávez
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Hermosillo, Sonora, Mexique, 83180
- Centro Avanzado de Atención a la Salud (CAAPS)
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Adults (>18 years of age and <65)
- Overweight or Obese (BMI >25 kg/m2 y <50 kg/m2)
- Availability and motivation to attend the intervention program
- Patients who would benefit from participating in the program according to the health providers
- Signing an informed consent
Exclusion Criteria:
- Medical conditions affecting body weight significantly
- Pregnancy or nursing
- Bariatric surgery
- Being unable to participate in regular moderate physical activity
- Blood pressure >160 mm/Hg
- HbA1c>9
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
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: Group Lifestyle Balance Program
Participants will be assigned to an adaptation of the "Group Lifestyle Balance Program", a behavioral curriculum implemented in the Diabetes Prevention Program Study. The Group Lifestyle Balance Program will be provided weekly for the first 3.5 months, bi-weekly from 3.5 to 6 months and then monthly until 12 months. Health care providers will be trained for the implementation of the intervention. Additionally, participants will attend at least one monthly visit with a nutritionist (individually). The lifestyle objectives for participants will be as follows:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change in body weight
Délai: Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
|
Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change in waist circumference
Délai: Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
|
Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
|
|
Change in body fat percentage
Délai: Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
|
Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
|
|
Change in the Beck Depression Inventory score
Délai: Change in the Beck Depression Inventory score from baseline to 6 months and change in in the Beck Depression Inventory score from baseline to 12 months
|
Change in the Beck Depression Inventory score from baseline to 6 months and change in in the Beck Depression Inventory score from baseline to 12 months
|
|
Change in the Short Form-36 Health Survey score
Délai: Change in the Short Form-36 Health Survey score from baseline to 6 months and change in the SF-36 Health Survey score from baseline to 12 months
|
Change in the Short Form-36 Health Survey score from baseline to 6 months and change in the SF-36 Health Survey score from baseline to 12 months
|
|
Change in the Perceived Stress Scale (PSS) -14 score
Délai: Change in the Perceived Stress Scale (PSS) -14 score from baseline to 6 months and change in the Perceived Stress Scale PSS-14 score from baseline to 12 months
|
Change in the Perceived Stress Scale (PSS) -14 score from baseline to 6 months and change in the Perceived Stress Scale PSS-14 score from baseline to 12 months
|
|
Change in systolic and diastolic blood pressure
Délai: Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
|
Change in systolic and diastolic blood pressure from baseline to 6 months and change in systolic and diastolic blood pressure from baseline to 12 months
|
|
Change in fasting glucose
Délai: Change in fasting glucose from baseline to 12 months
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Change in fasting glucose from baseline to 12 months
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|
Change in total cholesterol
Délai: Change in total colesterol from baseline to 12 months
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Change in total colesterol from baseline to 12 months
|
|
Change in LDL-cholesterol
Délai: Change in LDL-cholesterol from baseline to 12 months
|
Change in LDL-cholesterol from baseline to 12 months
|
|
Change in HDL-cholesterol
Délai: Change in HDL-cholesterol from baseline to 12 months
|
Change in HDL-cholesterol from baseline to 12 months
|
|
Change in triglycerides
Délai: Change in triglycerides from baseline to 12 months
|
Change in triglycerides from baseline to 12 months
|
|
Change in fasting insulin
Délai: Change in fasting insulin from baseline to 12 months
|
Change in fasting insulin from baseline to 12 months
|
|
Change in HOMA-IR
Délai: Change in HOMA-IR from baseline to 12 months
|
Change in HOMA-IR from baseline to 12 months
|
|
Change in liver enzymes [AST and ALT]
Délai: Change in liver enzymes [AST and ALT] from baseline to 12 months
|
Change in liver enzymes [AST and ALT] from baseline to 12 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Rolando G Díaz, Ph.D., Universidad de Sonora
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2015
Achèvement primaire (Anticipé)
1 avril 2017
Achèvement de l'étude (Anticipé)
1 avril 2017
Dates d'inscription aux études
Première soumission
25 août 2015
Première soumission répondant aux critères de contrôle qualité
28 août 2015
Première publication (Estimation)
2 septembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
23 mai 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 mai 2016
Dernière vérification
1 mai 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DPPMEX-077
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 .