Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program" (GLBOMEX)
20. Mai 2016 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
258
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
Sonora
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Hermosillo, Sonora, Mexiko, 83000
- Centro de Promoción de Salud Nutricional (CPSN)
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Hermosillo, Sonora, Mexiko, 83000
- Centro de Salud Urbano Dr. Domingo Olivares
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Hermosillo, Sonora, Mexiko, 83000
- Hospital General del Estado de Sonora
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Hermosillo, Sonora, Mexiko, 83000
- Hospital Ignacio Chávez
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Hermosillo, Sonora, Mexiko, 83180
- Centro Avanzado de Atención a la Salud (CAAPS)
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Change in body weight
Zeitfenster: Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
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Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Change in waist circumference
Zeitfenster: Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
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Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
|
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Change in body fat percentage
Zeitfenster: Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
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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
Zeitfenster: 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
Zeitfenster: 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
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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
|
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Change in the Perceived Stress Scale (PSS) -14 score
Zeitfenster: 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
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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
Zeitfenster: 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
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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
|
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Change in fasting glucose
Zeitfenster: 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
Zeitfenster: Change in total colesterol from baseline to 12 months
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Change in total colesterol from baseline to 12 months
|
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Change in LDL-cholesterol
Zeitfenster: Change in LDL-cholesterol from baseline to 12 months
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Change in LDL-cholesterol from baseline to 12 months
|
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Change in HDL-cholesterol
Zeitfenster: Change in HDL-cholesterol from baseline to 12 months
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Change in HDL-cholesterol from baseline to 12 months
|
|
Change in triglycerides
Zeitfenster: Change in triglycerides from baseline to 12 months
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Change in triglycerides from baseline to 12 months
|
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Change in fasting insulin
Zeitfenster: Change in fasting insulin from baseline to 12 months
|
Change in fasting insulin from baseline to 12 months
|
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Change in HOMA-IR
Zeitfenster: Change in HOMA-IR from baseline to 12 months
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Change in HOMA-IR from baseline to 12 months
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Change in liver enzymes [AST and ALT]
Zeitfenster: Change in liver enzymes [AST and ALT] from baseline to 12 months
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Change in liver enzymes [AST and ALT] from baseline to 12 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Rolando G Díaz, Ph.D., Universidad de Sonora
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2015
Primärer Abschluss (Voraussichtlich)
1. April 2017
Studienabschluss (Voraussichtlich)
1. April 2017
Studienanmeldedaten
Zuerst eingereicht
25. August 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. August 2015
Zuerst gepostet (Schätzen)
2. September 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
23. Mai 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Mai 2016
Zuletzt verifiziert
1. Mai 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DPPMEX-077
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