- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05631535
Obesity Treatment With a Very Low Energy Diet in Mexican Adults
December 2, 2022 updated by: Rolando Giovanni Díaz Zavala, Universidad de Sonora
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rolando G Díaz Zavala, Ph.D.
- Phone Number: 4632 (52)6622893793
- Email: giovanni.diaz@unison.mx
Study Locations
-
-
Sonora
-
Hermosillo, Sonora, Mexico, 83000
- Centro de Promoción de Salud Nutricional (CPSN)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention with a very low-energy diet
|
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.
|
Active Comparator: Control group
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in body weight
Time Frame: 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.
|
Baseline to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in body mass index
Time Frame: Baseline to 16 weeks
|
It is necessary to divide the weight in kilograms by the height in centimeters squared.
|
Baseline to 16 weeks
|
Changes in waist circumference
Time Frame: 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.
|
Baseline to 16 weeks
|
Changes in body fat
Time Frame: 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.
|
Baseline to 16 weeks
|
Changes in fat-free mass
Time Frame: Baseline to 16 weeks
|
They will obtain it by DXA with QDR, Hologic Discovery A; Hologic, Inc. Bedford, Ma, USA.
|
Baseline to 16 weeks
|
Changes in abdominal fat
Time Frame: 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.
|
Baseline to 16 weeks
|
Changes in systolic blood pressure
Time Frame: 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).
|
Baseline to 16 weeks
|
Changes in diastolic blood pressure
Time Frame: 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).
|
Baseline to 16 weeks
|
Changes in perception of health-related quality of life
Time Frame: 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.
|
Baseline to 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rolando G Díaz Zavala, Ph.D., Universidad de Sonora
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 8, 2022
Primary Completion (Anticipated)
June 2, 2023
Study Completion (Anticipated)
August 1, 2023
Study Registration Dates
First Submitted
November 18, 2022
First Submitted That Met QC Criteria
November 18, 2022
First Posted (Actual)
November 30, 2022
Study Record Updates
Last Update Posted (Estimate)
December 6, 2022
Last Update Submitted That Met QC Criteria
December 2, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USO313008177
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
The data obtained will be available from the corresponding author on the research request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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