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Obesity Treatment With a Very Low Energy Diet in Mexican Adults

Primary Purpose

Obesity, Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Intensive lifestyle change program with a very-low-energy diet
Intensive lifestyle change program with a low-energy diet
Sponsored by
Universidad de Sonora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Loss, Very Low Energy Diet

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Promoción de Salud Nutricional (CPSN)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention with a very low-energy diet

Control group

Arm Description

Outcomes

Primary Outcome Measures

Changes in body weight
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

Changes in body mass index
It is necessary to divide the weight in kilograms by the height in centimeters squared.
Changes in waist circumference
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 body fat
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 fat-free mass
They will obtain it by DXA with QDR, Hologic Discovery A; Hologic, Inc. Bedford, Ma, USA.
Changes in abdominal fat
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 systolic blood pressure
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 diastolic blood pressure
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
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.

Full Information

First Posted
November 18, 2022
Last Updated
January 31, 2023
Sponsor
Universidad de Sonora
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1. Study Identification

Unique Protocol Identification Number
NCT05631535
Brief Title
Obesity Treatment With a Very Low Energy Diet in Mexican Adults
Official Title
Evaluation of the Efficacy of the Diabetes Prevention Program With a Very-low-energy Diet or a Low-energy Diet on Body Weight at 4 Months in Mexican Adults With Obesity: Two-armed-Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
June 2, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Sonora

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Weight Loss, Very Low Energy Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention with a very low-energy diet
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Intensive lifestyle change program with a very-low-energy diet
Intervention Description
The intervention will consist of two phases. In the first phase, the participants receive weekly visits for two months. During these visits, a nutritionist will take the participants' weight and abdominal circumference measurements, and each one will receive a meal plan with a very low-energy diet (800 kcal/d). The second phase will implement in the third and fourth months, and nutritional counseling will continue to be provided every week in the third and biweekly in the fourth month. In this second phase, a gradual reintroduction to low-energy dietary meal plans (1200-1800 kcal/d) will perform. In addition, a specially adapted Diabetes Prevention Program for a very low-energy diet will implement.
Intervention Type
Other
Intervention Name(s)
Intensive lifestyle change program with a low-energy diet
Intervention Description
The structure (frequency of nutritional counseling, number of sessions, time of sessions, etc.) in this group will be the same as that of the intervention group, and a modified Diabetes Prevention Program will also provide. From the beginning of the study will recommend meal plans with a low-energy diet (1200-1800 kcal).
Primary Outcome Measure Information:
Title
Changes in body weight
Description
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.
Time Frame
Baseline to 16 weeks
Secondary Outcome Measure Information:
Title
Changes in body mass index
Description
It is necessary to divide the weight in kilograms by the height in centimeters squared.
Time Frame
Baseline to 16 weeks
Title
Changes in waist circumference
Description
Participants will be measured standing at the umbilical level, using a Lufkin Executive anthropometric tape measure, model W606PMMX, from 0 to 200 cm.
Time Frame
Baseline to 16 weeks
Title
Changes in body fat
Description
They will obtain it by Dual X-ray absorptiometry (DXA) with Quantitative Digital Radiography (QDR), Hologic Discovery A; Hologic, Inc. Bedford, Ma, USA.
Time Frame
Baseline to 16 weeks
Title
Changes in fat-free mass
Description
They will obtain it by DXA with QDR, Hologic Discovery A; Hologic, Inc. Bedford, Ma, USA.
Time Frame
Baseline to 16 weeks
Title
Changes in abdominal fat
Description
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.
Time Frame
Baseline to 16 weeks
Title
Changes in systolic blood pressure
Description
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).
Time Frame
Baseline to 16 weeks
Title
Changes in diastolic blood pressure
Description
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).
Time Frame
Baseline to 16 weeks
Title
Changes in perception of health-related quality of life
Description
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.
Time Frame
Baseline to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rolando G Díaz Zavala, Ph.D.
Phone
(52)6622893793
Ext
4632
Email
giovanni.diaz@unison.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolando G Díaz Zavala, Ph.D.
Organizational Affiliation
Universidad de Sonora
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Promoción de Salud Nutricional (CPSN)
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolando G Díaz-Zavala, Ph.D.
Phone
6622893793
Ext
4632
Email
giovanni.diaz@unison.mx
First Name & Middle Initial & Last Name & Degree
Rolando G Díaz-Zavala, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data obtained will be available from the corresponding author on the research request.

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Obesity Treatment With a Very Low Energy Diet in Mexican Adults

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