Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program"

Obesity Clinical Trial

— GLBOMEX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02537704
• Other study ID #: DPPMEX-077
• Status: Active, not recruiting
• Phase: N/A
• First received: August 25, 2015
• Last updated: May 20, 2016
• Start date: September 2015
• Est. completion date: April 2017

Study information

• Verified date: May 2016
• Source: Universidad de Sonora
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 258
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• Group Lifestyle Balance Program

Locations

Country	Name	City	State
Mexico	Centro Avanzado de Atención a la Salud (CAAPS)	Hermosillo	Sonora
Mexico	Centro de Promoción de Salud Nutricional (CPSN)	Hermosillo	Sonora
Mexico	Centro de Salud Urbano Dr. Domingo Olivares	Hermosillo	Sonora
Mexico	Hospital General del Estado de Sonora	Hermosillo	Sonora
Mexico	Hospital Ignacio Chávez	Hermosillo	Sonora

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Sonora

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months	No
Secondary	Change in waist circumference		Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months	No
Secondary	Change in body fat percentage		Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months	No
Secondary	Change in the Beck Depression Inventory score		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	No
Secondary	Change in the Short Form-36 Health Survey score		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	No
Secondary	Change in the Perceived Stress Scale (PSS) -14 score		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	No
Secondary	Change in systolic and diastolic blood pressure		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	No
Secondary	Change in fasting glucose		Change in fasting glucose from baseline to 12 months	No
Secondary	Change in total cholesterol		Change in total colesterol from baseline to 12 months	No
Secondary	Change in LDL-cholesterol		Change in LDL-cholesterol from baseline to 12 months	No
Secondary	Change in HDL-cholesterol		Change in HDL-cholesterol from baseline to 12 months	No
Secondary	Change in triglycerides		Change in triglycerides from baseline to 12 months	No
Secondary	Change in fasting insulin		Change in fasting insulin from baseline to 12 months	No
Secondary	Change in HOMA-IR		Change in HOMA-IR from baseline to 12 months	No
Secondary	Change in liver enzymes [AST and ALT]		Change in liver enzymes [AST and ALT] from baseline to 12 months	No

External Links

•   Pilot study