NCT02537704

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Universidad de Sonora · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
BEHAVIORAL	Group Lifestyle Balance Program

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2015-09-02
• Last updated: 2016-05-23

Locations

5 sites across 1 country: Mexico