An interventional study of Intervention group and Control group in Feeding Behavior, Diet, Reducing and Eating, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 20 Years to 59 Years. Per ClinicalTrials.gov, last updated 2017-11-20.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment
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.
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's planned enrollment of 110 is above the median of 77 across 700 interventional studies indexed under Feeding Behavior.
Browse Feeding Behavior studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The control group will also serve the dish the same way, but you can serve additional portion without waiting.
Other: Control 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.
The control group will also serve the dish of the form, but can serve additional portion without waiting.
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.
Time frame: 30 days
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.
Time frame: 30 days
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.
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2017 (actual). Primary completion is estimated for Dec 2017, 4 months after the start.
Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 4 months is below that.
Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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