Clinical trial NCT02537704: Translational Study for Obesity Management in Mexican Adults Using the "Group Lifestyle Balance Program"
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Overweight
Keywords: Obesity
Translational
Diabetes Prevention Program
Group Lifestyle Balance Program
Lead sponsor: Universidad de Sonora
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in body weight
timeFrame: Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months
Secondary outcomes:
measure: Change in waist circumference
timeFrame: Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months
measure: Change in body fat percentage
timeFrame: Change in body fat percentage from baseline to 6 months and change in body fat percentage from baseline to 12 months
measure: Change in the Beck Depression Inventory score
timeFrame: 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
measure: Change in the Short Form-36 Health Survey score
timeFrame: 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
measure: Change in the Perceived Stress Scale (PSS) -14 score
timeFrame: 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
measure: Change in systolic and diastolic blood pressure
timeFrame: 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
measure: Change in fasting glucose
timeFrame: Change in fasting glucose from baseline to 12 months
measure: Change in total cholesterol
timeFrame: Change in total colesterol from baseline to 12 months
measure: Change in LDL-cholesterol
timeFrame: Change in LDL-cholesterol from baseline to 12 months
measure: Change in HDL-cholesterol
timeFrame: Change in HDL-cholesterol from baseline to 12 months
measure: Change in triglycerides
timeFrame: Change in triglycerides from baseline to 12 months
measure: Change in fasting insulin
timeFrame: Change in fasting insulin from baseline to 12 months
measure: Change in HOMA-IR
timeFrame: Change in HOMA-IR from baseline to 12 months
measure: Change in liver enzymes [AST and ALT]
timeFrame: Change in liver enzymes [AST and ALT] from baseline to 12 months
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Centro de Promoción de Salud Nutricional (CPSN)
state: Sonora
city: Hermosillo
country: Mexico
facility: Centro de Salud Urbano Dr. Domingo Olivares
state: Sonora
city: Hermosillo
country: Mexico
facility: Hospital General del Estado de Sonora
state: Sonora
city: Hermosillo
country: Mexico
facility: Hospital Ignacio Chávez
state: Sonora
city: Hermosillo
country: Mexico
facility: Centro Avanzado de Atención a la Salud (CAAPS)
state: Sonora
Study officials:
affiliation: Universidad de Sonora
name: Rolando G Díaz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: