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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-04-30

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.

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Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group Lifestyle Balance Program

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.

Group Type EXPERIMENTAL

Group Lifestyle Balance Program

Intervention Type BEHAVIORAL

Interventions

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Group Lifestyle Balance Program

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No