Obesity Treatment With a Very Low Energy Diet in Mexican Adults

Not Applicable

Recruiting

• Conditions: Weight Loss; Obesity
• Interventions: Other: Intensive lifestyle change program with a very-low-energy diet; Other: Intensive lifestyle change program with a low-energy diet

• Registration Number: NCT05631535
• Lead Sponsor: Universidad de Sonora

Brief Summary

Clinical practice guidelines recommend behavioral change protocols for obesity treatment, such as the Diabetes Prevention Program, which involves a low-energy diet, physical activity recommendations, behavioral therapy, and frequent visits. Weight losses of 7-9% per year have achieve with this type of intervention. However, evidence suggests that a very low-energy diet may reach 10-15% weight loss and conduce superior clinical effects. Therefore, the objective will be to evaluate the efficacy of the Diabetes Prevention Program with a very-low energy diet and a low-energy diet on body weight change at four months in Mexican adults with obesity. The study will be a randomized controlled trial. Participants will be randomized to an intensive lifestyle change program with a very low-energy diet or an intensive lifestyle change program with a low-energy diet. The primary outcome will be a change in body weight. Secondary outcomes will be changes in waist circumference, body mass index, total body fat, fat-free mass, abdominal fat, blood pressure, and quality of life. Data will be analyzed on an intention-to-treat (ITT) using Student's t-tests or Mann-Whitney's U-test. The protocol was performed following the SPIRIT guidelines. Ethical approval was obtained from the Research Ethics Committee of the Department of Medicine of the University of Sonora.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-30
• Status Verified: 2023-01
• Study Start: 2023-01-04
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02
• Primary Completion: 2023-06-02
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adults (≥18 and ≤55 years of age).
• Residents of the city of Hermosillo, Sonora.
• BMI ≥ 30 and ≤ 40.
• Availability of time to participate in the study, including initial and final measurements.
• Have a device with access to the internet
• Availability and possibility to acquire the indicated diet
• Send a report of food consumption for three days

Exclusion Criteria

• Being a participant in a weight loss program.
• Weight loss major than 5% in the last six months.
• Have type 2 diabetes or hypertension (previous).
• Use of drugs with an effect on body weight ( steroids, injectable progestins, lithium, valproic acid, carbamazepine, antipsychotics, antidepressants, thiazolidinediones, levothyroxine, metformin, and anorexigenic drugs).
• Have a history of coronavirus disease with hospitalization or the presence of sequelae that prevent the intervention from being carried out.
• Have cancer, kidney disease, eating disorders, psychiatric disorder (depression) or other serious diseases, active biliary disease, or known asymptomatic gallstones.
• Pregnancy or breastfeeding.
• Use of medications for obesity.
• Use of illegal substances harmful to health (drugs).
• Illiteracy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention with a very low-energy diet	Intensive lifestyle change program with a very-low-energy diet	-
Control group	Intensive lifestyle change program with a low-energy diet	-

Primary Outcome Measures

Name	Time	Method
Changes in body weight	Baseline to 16 weeks	SECA medical body composition analyzer (mBCA) model 514 digital scale will be used. The participant should wear light clothing, remove footwear and metal objects, and have omitted food and beverages two hours before the measurement.

Secondary Outcome Measures

Name	Time	Method
Changes in body mass index	Baseline to 16 weeks	It is necessary to divide the weight in kilograms by the height in centimeters squared.
Changes in waist circumference	Baseline to 16 weeks	Participants will be measured standing at the umbilical level, using a Lufkin Executive anthropometric tape measure, model W606PMMX, from 0 to 200 cm.
Changes in fat-free mass	Baseline to 16 weeks	They will obtain it by DXA with QDR, Hologic Discovery A; Hologic, Inc. Bedford, Ma, USA.
Changes in abdominal fat	Baseline to 16 weeks	Estimation of abdominal fat, which includes visceral fat, will be obtained by DXA, QDR Hologic Discovery A; Hologic, Inc. Bedford, Ma, USA. For the definition of Region of Interest (ROI), will be used the APEX software version 3.0 and follow the criteria by the University of California (UCSF). The abdominal area will be selected as the ROI of the L2-upper iliac crest to monitor the change in abdominal fat. All body measurements will be taken in the dorsal decubitus position and at rest, without movement at the required time. If there is any movement during the measure, it will repeat with a limit of 2 attempts.
Changes in diastolic blood pressure	Baseline to 16 weeks	An Omron model HEM-907XL sphygmomanometer will be used to obtain the measurement in duplicate, following the methodology recommended by the American College of Cardiology (ACC) / American Heart Association (AHA).
Changes in body fat	Baseline to 16 weeks	They will obtain it by Dual X-ray absorptiometry (DXA) with Quantitative Digital Radiography (QDR), Hologic Discovery A; Hologic, Inc. Bedford, Ma, USA.
Changes in systolic blood pressure	Baseline to 16 weeks	An Omron model HEM-907XL sphygmomanometer will be used to obtain the measurement in duplicate, following the methodology recommended by the American College of Cardiology (ACC) / American Heart Association (AHA).
Changes in perception of health-related quality of life	Baseline to 16 weeks	The SF-36 Health Survey evaluates aspects of the quality of life in adult populations. This application generates eight concepts or scales of health, the result of the average of the sum of the points contains in the questionnaire for each item. These concepts are physical function, physical role, corporal pain, general health, vitality, social feature, emotional role, and mental health. The SF-36 is a self-applied instrument and contains 36 questions. For each scale, the answers to each question are coded and recoded (10 questions), and the results will be interprete on a scale of 0 to 100, the lowest results indicate poorer health, and the higher results are better health.

Trial Locations

Locations (1)

Centro de Promoción de Salud Nutricional (CPSN); 🇲🇽 Hermosillo, Sonora, Mexico