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

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ClinicalTrials.gov Identifier: NCT02537704
Recruitment Status : Unknown
Verified May 2016 by Rolando Giovanni Díaz Zavala, Universidad de Sonora.
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2015
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Rolando Giovanni Díaz Zavala, Universidad de Sonora

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: Group Lifestyle Balance Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Change in fasting glucose [ Time Frame: Change in fasting glucose from baseline to 12 months ]
  8. Change in total cholesterol [ Time Frame: Change in total colesterol from baseline to 12 months ]
  9. Change in LDL-cholesterol [ Time Frame: Change in LDL-cholesterol from baseline to 12 months ]
  10. Change in HDL-cholesterol [ Time Frame: Change in HDL-cholesterol from baseline to 12 months ]
  11. Change in triglycerides [ Time Frame: Change in triglycerides from baseline to 12 months ]
  12. Change in fasting insulin [ Time Frame: Change in fasting insulin from baseline to 12 months ]
  13. Change in HOMA-IR [ Time Frame: Change in HOMA-IR from baseline to 12 months ]
  14. 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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537704


Locations
Mexico
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, 83000
Centro Avanzado de Atención a la Salud (CAAPS)
Hermosillo, Sonora, Mexico, 83180
Sponsors and Collaborators
Universidad de Sonora
Investigators
Principal Investigator: Rolando G Díaz, Ph.D. Universidad de Sonora

Additional Information:
Responsible Party: Rolando Giovanni Díaz Zavala, Professor (Full)., Universidad de Sonora
ClinicalTrials.gov Identifier: NCT02537704     History of Changes
Other Study ID Numbers: DPPMEX-077
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016

Keywords provided by Rolando Giovanni Díaz Zavala, Universidad de Sonora:
Obesity
Translational
Diabetes Prevention Program
Group Lifestyle Balance Program

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms