- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03060161
Health in the Right Measure: Promoting Healthy Food and Regular Physical Activity Practice for UFRJ Servers (HRM)
Health in the Right Measure: Promoting Healthy Food and Regular Physical Activity Practice for UFRJ Server
Study Overview
Detailed Description
The initial goal of the project is to serve approximately thirty UFRJ servers at each edition. The project will be developed in up to two annual editions over a period of five years. After the selection of the candidates, an ambitious meeting will be held with all the participants in order to clarify the objectives and the other stages of the project.
Participants will then be scheduled for laboratory tests and consultations for medical evaluation (exercise test), nutritional assessment and physical evaluation. The anthropometric evaluation will be performed according to previously established protocols. Measurements of body weight, height and waist, abdominal, neck and hip circumference will be performed. The evaluation of the body composition will be performed using the multi-frequency electrical bioimpedance apparatus (Biodynamics® model 450). The usual food consumption quality will be evaluated through dietary records of 3 days (typical 2 days and 1 atypical). In order to evaluate the possible changes in the routine of physical activity practice, the international physical activity questionnaire (IPAQ) will be used in short form. The nutritional consultations will be carried out by nutritionists in the Nutritional Assessment Laboratory (NAL) of the Josué de Castro Nutrition Institute (JCNI).
Blood samples will be collected at the Laboratory of Clinical Analysis of the Faculty of Pharmacy of UFRJ or at the Clinical Pathology Service of the University Hospital Clementino Fraga Filho by properly trained personnel with disposable materials. Blood samples will be collected after a 12 hour fasting for analysis of the complete blood count, lipidogram, liver enzymes (aspartate transaminase and alanine transaminase), glycemia, glycated hemoglobin, free thyroxine and thyroid stimulating hormone.
After performing these evaluations, 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. In case of failure in the stress test the participant will not be able to participate in the physical exercise program, however, he will be invited to remain in activities aimed at promoting healthy eating habits.
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.
At the end of the project intervention period (12 weeks), the participants will again be submitted to laboratory examination and nutritional assessment: anthropometric and body composition evaluation and evaluation of changes in eating habits.
A collective closure meeting will be held at the end of the project intervention stage and all participants will be informed and will have access to the results of their evaluations to date.
In the next six months participants will be invited to monthly motivational collective activities (sporting challenges, conversation wheel, culinary workshop) as a way to stimulate them to maintain routine physical activities and changes in eating habits.
At the end of three months after the end of the intervention period (6 months of follow-up), the participants will be submitted to nutritional assessment. At the end of the six months after the end of the intervention period, the participants will be submitted to the same evaluations performed three months after the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Rio de Janeiro, Brazil, 21941-902
- Vanessa Chaia Kaippert
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be a server of UFRJ
- Be able to practice some regular physical activity
- Be willing to participate in the proposed activities.
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health in the right measure
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. |
Nutritional monitoring and individual guidance on regular physical exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Promote healthy eating habits
Time Frame: baseline, after 3 and 9 months
|
Changes in dietary habits will be assessed by completing dietary records for three days
|
baseline, after 3 and 9 months
|
|
Combat physical inactivity
Time Frame: baseline, after 3 and 9 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of lifestyle change on body weight
Time Frame: baseline, after 3, 6 and 9 months
|
Changes in body weight will be evaluated.
|
baseline, after 3, 6 and 9 months
|
|
Effects of lifestyle change on body circumference
Time Frame: baseline, after 3, 6 and 9 months
|
Changes in body circumference will be evaluated.
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baseline, after 3, 6 and 9 months
|
|
Effects of lifestyle change on body composition
Time Frame: baseline, after 3, 6 and 9 months
|
Changes in body composition will be evaluated by electrical bioimpedance
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baseline, after 3, 6 and 9 months
|
|
Effects of lifestyle change on biomarkers.
Time Frame: baseline, after 3 and 9 months
|
Lipid and glycemic profile will be evaluated.
|
baseline, after 3 and 9 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eliane Oliveira, Doctor, Adjunct Professor
Publications and helpful links
General Publications
- Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- 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.
- Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 123456 CEP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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