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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Group Lifestyle Balance Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Lifestyle Balance Program<br>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: To lose 5-10% of initial weight through healthy eating. To do 150 minutes of physical activity each week. | Behavioral: Group Lifestyle Balance Program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in waist circumference |  | Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Change in fasting glucose |  | Change in fasting glucose from baseline to 12 months | 
| Change in total cholesterol |  | Change in total colesterol from baseline to 12 months | 
| Change in LDL-cholesterol |  | Change in LDL-cholesterol from baseline to 12 months | 
| Change in HDL-cholesterol |  | Change in HDL-cholesterol from baseline to 12 months | 
| Change in triglycerides |  | Change in triglycerides from baseline to 12 months | 
| Change in fasting insulin |  | Change in fasting insulin from baseline to 12 months | 
| Change in HOMA-IR |  | Change in HOMA-IR from baseline to 12 months | 
| Change in liver enzymes [AST and ALT] |  | Change in liver enzymes [AST and ALT] from baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Translational, Diabetes Prevention Program, Group Lifestyle Balance Program