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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
258
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, Mexico
Centro Avanzado de Atención a la Salud (CAAPS)
Hermosillo, Sonora, Mexico
Change in body weight
Time frame: Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
Change in waist circumference
Time frame: Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
Change in body fat percentage
Time frame: 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
Time frame: 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
Time frame: 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
Change in the Perceived Stress Scale (PSS) -14 score
Time frame: 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
Time frame: 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
Time frame: Change in fasting glucose from baseline to 12 months
Change in total cholesterol
Time frame: Change in total colesterol from baseline to 12 months
Change in LDL-cholesterol
Time frame: Change in LDL-cholesterol from baseline to 12 months
Change in HDL-cholesterol
Time frame: Change in HDL-cholesterol from baseline to 12 months
Change in triglycerides
Time frame: Change in triglycerides from baseline to 12 months
Change in fasting insulin
Time frame: Change in fasting insulin from baseline to 12 months
Change in HOMA-IR
Time frame: Change in HOMA-IR from baseline to 12 months
Change in liver enzymes [AST and ALT]
Time frame: Change in liver enzymes [AST and ALT] from baseline to 12 months
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