Clinical trial NCT03347942: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Feeding Behavior
Diet, Reducing
Eating
Keywords: Overweight
Obesity
Satiety
Cardiovascular risk
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean body weight
timeFrame: 30 days
Secondary outcomes:
measure: Cardiovascular risk assessment scores
timeFrame: 30 days
measure: Waist diameter values
timeFrame: 30 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Tania W Furlanetto, PhD
role: STUDY_DIRECTOR
References: