Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program" (GLBOMEX)
20 mei 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
258
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Sonora
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Hermosillo, Sonora, Mexico, 83000
- Centro de Promoción de Salud Nutricional (CPSN)
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Hermosillo, Sonora, Mexico, 83000
- Centro de Salud Urbano Dr. Domingo Olivares
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Hermosillo, Sonora, Mexico, 83000
- Hospital General del Estado de Sonora
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Hermosillo, Sonora, Mexico, 83000
- Hospital Ignacio Chávez
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Hermosillo, Sonora, Mexico, 83180
- Centro Avanzado de Atención a la Salud (CAAPS)
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change in body weight
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change in waist circumference
Tijdsspanne: 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
Tijdsspanne: 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
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Change in the Beck Depression Inventory score
Tijdsspanne: 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
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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
|
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Change in the Short Form-36 Health Survey score
Tijdsspanne: 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
Tijdsspanne: 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
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Change in systolic and diastolic blood pressure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Change in HDL-cholesterol from baseline to 12 months
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Change in HDL-cholesterol from baseline to 12 months
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Change in triglycerides
Tijdsspanne: 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
Tijdsspanne: Change in fasting insulin from baseline to 12 months
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Change in fasting insulin from baseline to 12 months
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Change in HOMA-IR
Tijdsspanne: 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]
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Rolando G Díaz, Ph.D., Universidad de Sonora
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2015
Primaire voltooiing (Verwacht)
1 april 2017
Studie voltooiing (Verwacht)
1 april 2017
Studieregistratiedata
Eerst ingediend
25 augustus 2015
Eerst ingediend dat voldeed aan de QC-criteria
28 augustus 2015
Eerst geplaatst (Schatting)
2 september 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
23 mei 2016
Laatste update ingediend die voldeed aan QC-criteria
20 mei 2016
Laatst geverifieerd
1 mei 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DPPMEX-077
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