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

NCT03347942 | Unknown

• 1 other identifier: 16-0327
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Behavior; Diet, Reducing; Eating

Keywords

Overweight; Obesity; Satiety; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cardiovascular risk assessment scores

  30 days

• Waist diameter values

  30 days

Study Arms (2)

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.

Behavioral: Intervention group

Control

OTHER

The control group will also serve the dish the same way, but you can serve additional portion without waiting.

Other: Control group

Interventions

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.

Intervention

Control group OTHER

The control group will also serve the dish of the form, but can serve additional portion without waiting.

Control

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Overweight and obesity grade I, according to WHO criteria (1998).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

RECRUITING

MeSH Terms

Conditions

Feeding Behavior; Overweight; Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Tania W Furlanetto, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Central Study Contacts

Milena Artifon, Nutritionist

CONTACT

55 54 991661416; milena.artifon@gmail.com

Thaís R Moreira, Nutritionist

CONTACT

55 51 999161004; thaisr_moreira@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 20, 2017
• Study Start: August 10, 2017
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: November 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)