Clinical Study Randomized of the Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Mean body weight
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 20 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Intervention group (Behavioral)
Control
The control group will also serve the dish the same way, but you can serve additional portion without waiting.
Intervention: Control group (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Cardiovascular risk assessment scores(30 days)
- Waist diameter values(30 days)