Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity
Primary Purpose
Feeding Behavior, Diet, Reducing, Eating
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Feeding Behavior focused on measuring Overweight, Obesity, Satiety, Cardiovascular risk
Eligibility 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.
Sites / Locations
- Hospital de Clínicas de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm 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.
The control group will also serve the dish the same way, but you can serve additional portion without waiting.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03347942
First Posted
November 16, 2017
Last Updated
November 16, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03347942
Brief Title
Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity
Official Title
Clinical Study Randomized of the Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Behavior, Diet, Reducing, Eating
Keywords
Overweight, Obesity, Satiety, Cardiovascular risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Other
Arm Description
The control group will also serve the dish the same way, but you can serve additional portion without waiting.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The control group will also serve the dish of the form, but can serve additional portion without waiting.
Primary Outcome Measure Information:
Title
Mean body weight
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Cardiovascular risk assessment scores
Description
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.
Time Frame
30 days
Title
Waist diameter values
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Milena Artifon, Nutritionist
Phone
55 54 991661416
Email
milena.artifon@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thaís R Moreira, Nutritionist
Phone
55 51 999161004
Email
thaisr_moreira@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania W Furlanetto, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena Artifon, Nutricionist
Phone
55 54 991661416
Email
milena.artifon@gmail.com
First Name & Middle Initial & Last Name & Degree
Thaís R Moreira, Nutricionist
Phone
55 51 999161004
Email
thaisr_moreira@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity
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