Clinical trial NCT05631535: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: Obesity
Weight Loss
Very Low Energy Diet
Lead sponsor: Universidad de Sonora
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in body weight
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Changes in body mass index
timeFrame: Baseline to 16 weeks
measure: Changes in waist circumference
timeFrame: Baseline to 16 weeks
measure: Changes in body fat
timeFrame: Baseline to 16 weeks
measure: Changes in fat-free mass
timeFrame: Baseline to 16 weeks
measure: Changes in abdominal fat
timeFrame: Baseline to 16 weeks
measure: Changes in systolic blood pressure
timeFrame: Baseline to 16 weeks
measure: Changes in diastolic blood pressure
timeFrame: Baseline to 16 weeks
measure: Changes in perception of health-related quality of life
timeFrame: Baseline to 16 weeks
Other outcomes:
Locations:
city: Hermosillo
country: Mexico
facility: Centro de Promoción de Salud Nutricional (CPSN)
state: Sonora
Study officials:
affiliation: Universidad de Sonora
name: Rolando G Díaz Zavala, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: