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

Universidad de Sonora

Status: Unknown

Conditions: Overweight; Obesity

Treatments: Behavioral: Group Lifestyle Balance Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02537704

DPPMEX-077

Details and patient eligibility

About

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.

Enrollment: 258 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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258 participants in 1 patient group

Group Lifestyle Balance Program

Experimental group

Description:

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: 1. To lose 5-10% of initial weight through healthy eating. 2. To do 150 minutes of physical activity each week.

Treatment:

Behavioral: Group Lifestyle Balance Program