NCT03060161

Brief Summary

Introduction: The epidemiological transition is one of the factors related to the increase in the prevalence of chronic noncommunicable diseases (CNCD), such as cardiovascular diseases, diabetes and cancer. Among the risks of risk to the development of CNCD are obesity, smoking, alcoholism, sedentary lifestyle and inadequate eating habits, with the last two levels having a high impact on gender and disease progression. Objectives: To promote healthy eating habits and to combat physical inactivity through nutritional monitoring and regular physical exercise, using a competition to stimulate adherence of the institution's employees. Methods: The present project is in agreement with the longitudinal study with the work of evaluation (anthropometric, body composition, laboratory and food consumption), in the eats of the times (at the beginning and end of the four-month intervention period). According to nutritional monitoring and individual guidance on regular physical exercise practice over a period of 12 weeks. Weight reduction, body fat reduction, changes in working methods and eating habits, and the relationship to routine physical activity after the intervention period, and are retested after six months. Expected results: Reduction of sedentary lifestyle, weight loss and body fat, improvement of eating habits, quality of life without working environment and health condition of the participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 10, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

4.2 years

First QC Date

February 15, 2017

Last Update Submit

July 28, 2022

Conditions

Keywords

Health promotionHealthy DietExercise

Outcome Measures

Primary Outcomes (2)

  • Promote healthy eating habits

    Changes in dietary habits will be assessed by completing dietary records for three days

    baseline, after 3 and 9 months

  • Combat physical inactivity

    Changes in routine physical activity will be assessed through the International Physical Activity Questionnaire (IPAQ) in the short form.

    baseline, after 3 and 9 months

Secondary Outcomes (4)

  • Effects of lifestyle change on body weight

    baseline, after 3, 6 and 9 months

  • Effects of lifestyle change on body circumference

    baseline, after 3, 6 and 9 months

  • Effects of lifestyle change on body composition

    baseline, after 3, 6 and 9 months

  • Effects of lifestyle change on biomarkers.

    baseline, after 3 and 9 months

Study Arms (1)

Health in the right measure

EXPERIMENTAL

Nutrition counseling and guidance for regular physical activity. An individualized physical exercise program will be proposed according to each participant's level of physical activity and health conditions. Participants will also receive individualized nutritional guidance. Throughout the project, collective motivational activities will be carried out to promote healthy eating (culinary workshops, talk wheels and others) and individual activities with all participants, in order to evaluate the adherence of nutritional guidelines and to exchange experiences among them.

Behavioral: Health in the right measure

Interventions

Nutritional monitoring and individual guidance on regular physical exercise.

Health in the right measure

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be a server of UFRJ
  • Be able to practice some regular physical activity
  • Be willing to participate in the proposed activities.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanessa Chaia Kaippert

Rio de Janeiro, 21941-902, Brazil

Location

Related Publications (8)

  • Ferreira VA, Magalhaes R. [Nutrition and health promotion: recent perspectives]. Cad Saude Publica. 2007 Jul;23(7):1674-81. doi: 10.1590/s0102-311x2007000700019. Portuguese.

    PMID: 17572817BACKGROUND
  • Flegal KM, Shepherd JA, Looker AC, Graubard BI, Borrud LG, Ogden CL, Harris TB, Everhart JE, Schenker N. Comparisons of percentage body fat, body mass index, waist circumference, and waist-stature ratio in adults. Am J Clin Nutr. 2009 Feb;89(2):500-8. doi: 10.3945/ajcn.2008.26847. Epub 2008 Dec 30.

    PMID: 19116329BACKGROUND
  • Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Manuel Gomez J, Lilienthal Heitmann B, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, M W J Schols A, Pichard C; ESPEN. Bioelectrical impedance analysis-part II: utilization in clinical practice. Clin Nutr. 2004 Dec;23(6):1430-53. doi: 10.1016/j.clnu.2004.09.012.

    PMID: 15556267BACKGROUND
  • Lukaski HC, Johnson PE, Bolonchuk WW, Lykken GI. Assessment of fat-free mass using bioelectrical impedance measurements of the human body. Am J Clin Nutr. 1985 Apr;41(4):810-7. doi: 10.1093/ajcn/41.4.810.

    PMID: 3984933BACKGROUND
  • Sookoian S, Pirola CJ. Genetics of the cardiometabolic syndrome: new insights and therapeutic implications. Ther Adv Cardiovasc Dis. 2007 Oct;1(1):37-47. doi: 10.1177/1753944707082702.

    PMID: 19124394BACKGROUND
  • Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

    PMID: 11234459BACKGROUND
  • Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.

    PMID: 8594834BACKGROUND
  • Zeyda M, Stulnig TM. Obesity, inflammation, and insulin resistance--a mini-review. Gerontology. 2009;55(4):379-86. doi: 10.1159/000212758. Epub 2009 Apr 8.

    PMID: 19365105BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Health

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Eliane Oliveira, Doctor

    adjunct professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The present project corresponds to a longitudinal study. Intervention will be performed soon after the initial diagnosis, through nutritional monitoring and individual guidance on regular physical exercise for a period of 12 weeks. Participants will be evaluated for weight loss, body fat reduction, changes in laboratory parameters and eating habits and in relation to the routine of physical activities immediately after the intervention period, and will be retested after six months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 23, 2017

Study Start

May 10, 2018

Primary Completion

July 28, 2022

Study Completion

July 28, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations