Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program" (GLBOMEX)
20. mai 2016 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
258
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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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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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in body weight
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in waist circumference
Tidsramme: 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
|
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Change in body fat percentage
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Change in triglycerides from baseline to 12 months
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Change in triglycerides from baseline to 12 months
|
|
Change in fasting insulin
Tidsramme: Change in fasting insulin from baseline to 12 months
|
Change in fasting insulin from baseline to 12 months
|
|
Change in HOMA-IR
Tidsramme: 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]
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Rolando G Díaz, Ph.D., Universidad de Sonora
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2015
Primær fullføring (Forventet)
1. april 2017
Studiet fullført (Forventet)
1. april 2017
Datoer for studieregistrering
Først innsendt
25. august 2015
Først innsendt som oppfylte QC-kriteriene
28. august 2015
Først lagt ut (Anslag)
2. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
23. mai 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. mai 2016
Sist bekreftet
1. mai 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DPPMEX-077
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