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

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ClinicalTrials.gov Identifier: NCT03347942
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief 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.


Condition or disease Intervention/treatment Phase
Feeding Behavior Diet, Reducing Eating Behavioral: Intervention group Other: Control group Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized and controlled clinical trial in adults of both sexes, overweight and obese who accepted to participate in the research at the Hospital de Clínicas in the city of Porto Alegre. Individuals will be divided into two paired groups for age, gender and waist diameter. These two groups will be randomized by lottery.
Masking: Single (Outcomes Assessor)
Masking Description: Participants will not be blinded, as they will be instructed to perform the intervention in the control of meal time. This is a limitation of the study design, however, it is expected to minimize the bias by not explaining to the participants what is expected by the intervention of the research. The researcher, who will measure the outcomes, will not know to which group the individual belongs.
Primary Purpose: Treatment
Official Title: Clinical Study Randomized of the Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Intervention
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.
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.

Control
The control group will also serve the dish the same way, but you can serve additional portion without waiting.
Other: Control group
The control group will also serve the dish of the form, but can serve additional portion without waiting.




Primary Outcome Measures :
  1. Mean body weight [ Time Frame: 30 days ]
    • 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.


Secondary Outcome Measures :
  1. Cardiovascular risk assessment scores [ Time Frame: 30 days ]
    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.

  2. Waist diameter values [ Time Frame: 30 days ]
    • 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.



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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347942


Contacts
Contact: Milena Artifon, Nutritionist 55 54 991661416 milena.artifon@gmail.com
Contact: Thaís R Moreira, Nutritionist 55 51 999161004 thaisr_moreira@hotmail.com

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
Contact: Milena Artifon, Nutricionist    55 54 991661416    milena.artifon@gmail.com   
Contact: Thaís R Moreira, Nutricionist    55 51 999161004    thaisr_moreira@hotmail.com   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Study Director: Tania W Furlanetto, PhD Hospital de Clínicas de Porto Alegre

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03347942     History of Changes
Other Study ID Numbers: 16-0327
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
Overweight
Obesity
Satiety
Cardiovascular risk

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms