Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity

Clinical Study Randomized of the Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity

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.

Study Overview

• Status: Unknown
• Conditions: Feeding Behavior; Diet, Reducing; Eating
• Intervention / Treatment: Behavioral: Intervention group; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Milena Artifon, Nutricionist; Phone Number: 55 54 991661416; Email: milena.artifon@gmail.com
      • Contact: Thaís R Moreira, Nutricionist; Phone Number: 55 51 999161004; Email: thaisr_moreira@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Intervention 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.
Other: Control; The control group will also serve the dish the same way, but you can serve additional portion without waiting.	Other: Control group; The control group will also serve the dish of the form, but can serve additional portion without waiting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	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	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.	30 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Director: Tania W Furlanetto, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 16, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Cardiovascular risk; Satiety
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 16-0327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No