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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | Other | The control group will also serve the dish the same way, but you can serve additional portion without waiting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean body weight |
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Waist diameter values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Milena Artifon, Nutritionist | Contact | 55 54 991661416 | milena.artifon@gmail.com | |
| Thaís R Moreira, Nutritionist | Contact | 55 51 999161004 | thaisr_moreira@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tania W Furlanetto, PhD | Hospital de Clínicas de Porto Alegre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clínicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035903 | Brazil |
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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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.
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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.
|
| Control group | Other | The control group will also serve the dish of the form, but can serve additional portion without waiting. |
|
|
| 30 days |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |