Obesity Treatment With a Very Low Energy Diet in Mexican Adults

NCT05631535 | Unknown

• 1 other identifier: USO313008177
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Obesity; Weight Loss; Very Low Energy Diet

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 16 weeks

Secondary Outcomes (8)

• Changes in body mass index

  Baseline to 16 weeks

• Changes in waist circumference

  Baseline to 16 weeks

• Changes in body fat

  Baseline to 16 weeks

• Changes in fat-free mass

  Baseline to 16 weeks

• Changes in abdominal fat

  Baseline to 16 weeks

Study Arms (2)

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

Interventions

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

Intervention with a very low-energy diet

Intensive lifestyle change program with a low-energy diet 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).

Control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Sonora: lead

Study Sites (1)

Centro de Promoción de Salud Nutricional (CPSN)

Hermosillo, Sonora, 83000, Mexico

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Rolando G Díaz Zavala, Ph.D.

  Universidad de Sonora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rolando G Díaz Zavala, Ph.D.

CONTACT

(52)6622893793; giovanni.diaz@unison.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 30, 2022
• Study Start: January 4, 2023
• Primary Completion: June 2, 2023
• Study Completion: August 1, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

ME (1)