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

May 20, 2016 updated by: Rolando Giovanni Díaz Zavala, Universidad de Sonora

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Sonora
      • Hermosillo, Sonora, Mexico, 83000
        • Centro de Promoción de Salud Nutricional (CPSN)
      • Hermosillo, Sonora, Mexico, 83000
        • Centro de Salud Urbano Dr. Domingo Olivares
      • Hermosillo, Sonora, Mexico, 83000
        • Hospital General del Estado de Sonora
      • Hermosillo, Sonora, Mexico, 83000
        • Hospital Ignacio Chávez
      • Hermosillo, Sonora, Mexico, 83180
        • Centro Avanzado de Atención a la Salud (CAAPS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Group Lifestyle Balance Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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 body weight from baseline to 6 months and change in body weight from baseline to 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Sonora

Investigators

  • Principal Investigator: Rolando G Díaz, Ph.D., Universidad de Sonora

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 20, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPPMEX-077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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