Clinical trial NCT03060161: Health in the Right Measure: Promoting Healthy Food and Regular Physical Activity Practice for UFRJ Servers
Official title: Health in the Right Measure: Promoting Healthy Food and Regular Physical Activity Practice for UFRJ Server
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human
Keywords: Health promotion
Healthy Diet
Exercise
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 65
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Promote healthy eating habits
timeFrame: baseline, after 3 and 9 months
measure: Combat physical inactivity
timeFrame: baseline, after 3 and 9 months
Secondary outcomes:
measure: Effects of lifestyle change on body weight
timeFrame: baseline, after 3, 6 and 9 months
measure: Effects of lifestyle change on body circumference
timeFrame: baseline, after 3, 6 and 9 months
measure: Effects of lifestyle change on body composition
timeFrame: baseline, after 3, 6 and 9 months
measure: Effects of lifestyle change on biomarkers.
timeFrame: baseline, after 3 and 9 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Vanessa Chaia Kaippert
Study officials:
affiliation: adjunct professor
name: Eliane Oliveira, Doctor
role: PRINCIPAL_INVESTIGATOR
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