ObesityNCT05631535
Obesity Treatment With a Very Low Energy Diet in Mexican Adults
A study testing Intensive lifestyle change program with a very-low-energy diet and Intensive lifestyle change program with a low-energy diet in people with Obesity and Weight Loss, run by Universidad de Sonora at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Intensive lifestyle change program with a very-low-energy diet and Intensive lifestyle change program with a low-energy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 4 Jan 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Pregnancy or breastfeeding.
- Use of medications for obesity.
- Use of illegal substances harmful to health (drugs).
- Illiteracy.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro de Promoción de Salud Nutricional (CPSN)
Hermosillo, Sonora, 83000
Rolando G Díaz-Zavala, Ph.D., 6622893793 ext. 4632, giovanni.diaz@unison.mx
Rolando G Díaz-Zavala, Ph.D.
About this study
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
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.
- Conditions
- Obesity, Weight Loss
- Being tested
- Intensive lifestyle change program with a very-low-energy diet, Intensive lifestyle change program with a low-energy diet
- Keywords
- Obesity, Weight Loss, Very Low Energy Diet
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive lifestyle change program with a very-low-energy dietOther
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.
Intensive lifestyle change program with a low-energy dietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention with a very low-energy diet | Experimental | Not described Receives: Other: Intensive lifestyle change program with a very-low-energy diet |
| Control group | Active comparator | Not described Receives: Other: Intensive lifestyle change program with a low-energy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 16 weeks
Secondary outcomes (8)
Changes in body mass index
It is necessary to divide the weight in kilograms by the height in centimeters squared.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
Changes in fat-free mass
They will obtain it by DXA with QDR, Hologic Discovery A; Hologic, Inc. Bedford, Ma, USA.
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
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).
Measured: Baseline to 16 weeks
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).
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start4 Jan 2023
- Primary completion2 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Sonora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolando Giovanni Díaz Zavala, Universidad de Sonora
- Investigators
- Rolando G Díaz Zavala, Ph.D., Principal investigator, Universidad de Sonora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631535
- Sponsor's protocol ID
- USO313008177
- Status last verified
- Jan 2023
- First submitted
- 18 Nov 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data obtained will be available from the corresponding author on the research request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05631535
- Acronym / sponsor ID
- USO313008177
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Weight Loss, Very Low Energy Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de SonoraUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 2 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention with a very low-energy diet | Experimental | Other: Intensive lifestyle change program with a very-low-energy diet |
| Control group | Active comparator | Other: Intensive lifestyle change program with a low-energy diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive lifestyle change program with a very-low-energy dietThe 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. | Other | Intervention with a very low-energy diet |
| Intensive lifestyle change program with a low-energy dietThe 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). | Other | Control group |
Primary outcome
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.
8 secondary outcomes
Changes in body mass index
Time frame: Baseline to 16 weeks
Changes in waist circumference
Time frame: Baseline to 16 weeks
Changes in body fat
Time frame: Baseline to 16 weeks
Changes in fat-free mass
Time frame: Baseline to 16 weeks
Changes in abdominal fat
Time frame: Baseline to 16 weeks
Changes in systolic blood pressure
Time frame: Baseline to 16 weeks
Changes in diastolic blood pressure
Time frame: Baseline to 16 weeks
Changes in perception of health-related quality of life
Time frame: Baseline to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided. The data obtained will be available from the corresponding author on the research request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolando G Díaz Zavala, Ph.D. principal investigator
Universidad de Sonora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive lifestyle change program with a very-low-energy diet and Intensive lifestyle change program with a low-energy diet in people with Obesity and Weight Loss, run by Universidad de Sonora at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rolando G Díaz Zavala, Ph.D. ((52)6622893793 ext. 4632, giovanni.diaz@unison.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: Baseline to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.