Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Feeding Behavior; Eating; Diet, Reducing

Treatments: Other: Control group; Behavioral: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT03347942

16-0327

Details and patient eligibility

About

Objectives: To evaluate the impact of the meal time administered on the body weight of adult individuals of both sexes, being overweight and obese.

Experimental design: randomized controlled trial. Place of research: Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.

Materials and methods: Anthropometric data, blood pressure, waist diameter will be measured; venous blood samples will be collected and stored for glucose, total cholesterol, triglycerides, HDL-cholesterol, urea, creatinine and ALT in serum.

Intervention: Wait at least 20 minutes after finishing the first portion of meals, previously considered sufficient by the individual before serving again. The control group will also serve the dish the same way, but you can serve additional portion without waiting.

Measurements: P values less than 0.05 will be considered statistically significant.

Expected results: Weight loss, decrease in anthropometric markers and risk factors for cardiovascular diseases.

Full description

Introduction: The increasing rates of overweight and obesity in the world population have worried health professionals about their quality and life expectancy. Intervention methods such as weight management programs can promote eating behaviors more suited to the energy needs of these individuals.

Objectives: To evaluate the impact of the meal time administered on the body weight of adult individuals of both sexes, overweight and obese.

Experimental design: randomized controlled trial. Place of research: Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.

Participants: Adults of both sexes. Materials and methods: Individuals will be invited to participate and will receive a free and informed consent form. If they agree, anthropometric data, blood pressure, waist diameter will be measured; venous blood samples will be collected and stored for glucose, total cholesterol, triglycerides, HDL-cholesterol, urea, creatinine and ALT in serum.

Intervention: Wait at least 20 minutes after finishing the first portion of meals, previously considered sufficient by the individual before serving again. The control group will also serve the dish the same way, but you can serve additional portion without waiting.

Measurements: The Kolmogorov-Smirnoff tests will be used to evaluate the distribution of continuous variables, and Student's t test, Mann-Whitney, and chi-square test, when appropriate. Values of p less than 0.05 will be considered statistically significant.

Expected results: Adults randomized to receive the intervention will gain weight loss, decrease in anthropometric markers and risk factors for cardiovascular diseases.

Project cost / benefit: Low cost and risk study that will contribute to the development of actions and programs related to the reduction of risk factors due to overweight and disease prevention.

Enrollment: 110 estimated patients

Sex: All

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Overweight and obesity grade I, according to WHO criteria (1998).

Exclusion criteria

• Normal weight, obesity> grade I;
• Use of appetite-enhancing medications such as glucocorticoids, tricyclic antidepressants, antipsychotics, mood modulators and anticonvulsants, or reduce body weight , such as anorexigenics, and antidiabetics that can modify body weight;
• In follow-up or nutritional intervention already established and;
• Refusal to sign the informed consent form.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Intervention

Experimental group

Description:

During a period of 30 days the research participant in the intervention group will be instructed to wait at least 20 minutes after finishing the first portion of meals previously considered sufficient by the individual before being served again if he or she feels the need.

Treatment:

Behavioral: Intervention group

Control

Other group

Description:

The control group will also serve the dish the same way, but you can serve additional portion without waiting.

Treatment:

Other: Control group