Obesity Treatment With a Very Low Energy Diet in Mexican Adults

Universidad de Sonora

Status

Enrolling

Conditions

Weight Loss

Obesity

Treatments

Other: Intensive lifestyle change program with a low-energy diet

Other: Intensive lifestyle change program with a very-low-energy diet

Study type

Interventional

Funder types

Other

Identifiers

NCT05631535

USO313008177

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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.