Overview

This trial is active, not recruiting.

Conditions obesity, overweight
Treatment group lifestyle balance program
Sponsor Universidad de Sonora
Start date September 2015
End date April 2017
Trial size 258 participants
Trial identifier NCT02537704, DPPMEX-077

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
group lifestyle balance program

Primary Outcomes

Measure
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 Outcomes

Measure
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 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 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 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 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 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 fasting glucose
time frame: 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 LDL-cholesterol
time frame: 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 triglycerides
time frame: 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 HOMA-IR
time frame: 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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Principal investigator Rolando G Díaz, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universidad de Sonora.