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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03347942
Other study ID # 16-0327
Secondary ID
Status Recruiting
Phase N/A
First received November 16, 2017
Last updated November 16, 2017
Start date August 10, 2017
Est. completion date July 2018

Study information

Verified date September 2017
Source Hospital de Clinicas de Porto Alegre
Contact Milena Artifon, Nutritionist
Phone 55 54 991661416
Email milena.artifon@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date July 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 59 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention group
Wait at least 20 minutes after finishing the first portion of meals previously considered sufficient by the individual before serving again if he or she feels the need. The intervention time will be monitored by the participants themselves, who will be instructed by the researcher when the methodology to be performed.
Other:
Control group
The control group will also serve the dish of the form, but can serve additional portion without waiting.

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean body weight Measurement of body weight in kilograms - will be carried out on the balance of Toledo® brand with a capacity of 200 kg, after urinating.
The individual will keep his body erect, with arms hanging over the body and heels attached.
Participants should only be in their underwear and disposable surgical dress, barefoot.
30 days
Secondary Cardiovascular risk assessment scores The calculation will be done with the CV Risk Calculator tool of the American College of Cardiology and the American Cardiology Association to obtain the percentage (%) risk for acute myocardial infarction or stroke in ten years. 30 days
Secondary Waist diameter values It will be obtained with flexible tape and inelastic (in centimeters), with the individual standing erect, arms extended along the body and feet together.
The tape will be positioned at the midpoint between the iliac crest and the outer side of the last rib.
30 days
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