Obesity Treatment With a Very Low Energy Diet in Mexican Adults

NCT ID: NCT05631535

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-04
• Study Completion Date: 2023-08-01

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.

Conditions

Obesity; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention with a very low-energy diet

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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.

Control group

Group Type: ACTIVE_COMPARATOR

Intensive lifestyle change program with a low-energy diet

Intervention Type: OTHER

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).

Interventions

Intensive lifestyle change program 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.

Intervention Type: OTHER

Intensive lifestyle change program with a low-energy diet

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Sonora

OTHER

Sponsor Role: lead

Responsible Party

Rolando Giovanni Díaz Zavala

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rolando G Díaz Zavala, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Universidad de Sonora

Locations

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Rolando G Díaz Zavala, Ph.D.

Role: CONTACT

giovanni.diaz@unison.mx

(52)6622893793 ext. 4632

Facility Contacts

Rolando G Díaz-Zavala, Ph.D.

Role: primary

giovanni.diaz@unison.mx

6622893793 ext. 4632

Other Identifiers

USO313008177

Identifier Type: -

Identifier Source: org_study_id