NCT05631535

Obesity Treatment With a Very Low Energy Diet in Mexican Adults

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universidad de Sonora · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.
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).

Timeline

• Start date: 2023-01-04
• Primary completion: 2023-06-02
• Completion: 2023-08-01
• First posted: 2022-11-30
• Last updated: 2023-02-02

Locations

1 site across 1 country: Mexico