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

NCT02537704 | Unknown

• 1 other identifier: DPPMEX-077
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 5

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.

Conditions

Obesity; Overweight

Keywords

Obesity; Translational; Diabetes Prevention Program; Group Lifestyle Balance Program

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Change in body weight from baseline to 6 months and change in body weight from baseline to 12 months

Secondary Outcomes (14)

• Change in waist circumference

  Change in waist circumference from baseline to 6 months and change in waist circumference from baseline to 12 months

• Change in body fat percentage

  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

  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

  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

  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

Study Arms (1)

Group Lifestyle Balance Program

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: 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

Interventions

Group Lifestyle Balance Program BEHAVIORAL

Group Lifestyle Balance Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Sonora: lead

Study Sites (5)

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, 83000, Mexico

Location

Centro de Salud Urbano Dr. Domingo Olivares

Hermosillo, Sonora, 83000, Mexico

Location

Hospital General del Estado de Sonora

Hermosillo, Sonora, 83000, Mexico

Location

Hospital Ignacio Chávez

Hermosillo, Sonora, 83000, Mexico

Location

Centro Avanzado de Atención a la Salud (CAAPS)

Hermosillo, Sonora, 83180, Mexico

Location

Related Publications (1)

• Ruelas AL, Martinez Contreras TJ, Esparza Romero J, Diaz Zavala RG, Candia Plata MDC, Hingle M, Armenta Guirado B, Haby MM. Factors influencing adults to drop out of intensive lifestyle interventions for weight loss. Transl Behav Med. 2023 Apr 15;13(4):245-254. doi: 10.1093/tbm/ibac112.

  PMID: 36694376 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rolando G Díaz, Ph.D.

  Universidad de Sonora

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Full).

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 2, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 23, 2016

Record last verified: 2016-05

Locations

ME (5)