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Evaluating the Efficacy of the Feeding Exercise Trial in Adolescents (FETA Project) in Central Greece (FETA)

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ClinicalTrials.gov Identifier: NCT02653508
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Hadjichristodoulou Christos, University of Thessaly

Brief Summary:
The Feeding-Exercise Trial in Adolescents (FETA) was a randomised controlled intervention study designed to promote healthy weight in overweigh and obese adolescents through a professional-delivered, community-based program with active parents' involvement, focused on supervised physical activity and structured nutritional education. The aim of FETA was to test the efficacy of two intervention groups- physical activity in isolation and combination of physical activity with provision of dietary information- for improving overweight and obesity in adolescents. Our primary hypothesis was that a combined program would be more efficacious than activity in isolation and that activity alone would also be effective compared to control group in improving adiposity profiles in overweight and obese adolescents as well as family activity and feeding habits.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Diet and Activity Behavioral: Activity Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Evaluating the Efficacy of the Feeding Exercise Trial in Adolescents (FETA Project) in Central Greece
Study Start Date : September 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diet and Activity
60 overweight and obese adolescents aged 13-15 years old took part in the clinical trial and remained at the end of the 3 months intervention program and also at the 6 months follow up. The activity intervention included a 45 minutes, three-day per week supervised training programme, while the nutritional education comprised of a supplementary 15 minutes of group-based sessions that could be also attended by the parents. All adolescents were assessed for anthropometric measures, fitness and activity and family habits along with their parents.
Behavioral: Diet and Activity
During all the following meetings, before the initiation of the training sessions, 10 to 15 minutes were devoted to an interactive discussion with participants on food pyramid, food choices, food labels, food preparation and cooking, eating habits, regular meals, controlling environments that stimulate overeating. All adolescents participated in a three-day per week training programme (45 minutes per training session). Many activities were delivered as games in order to encourage enthusiasm and participation. Endurance type activities accounted for most of the time spent in training (about 50% team sports and 50% running games), with attention to coordination and flexibility skills.

Experimental: Activity
60 overweight and obese adolescents aged 13-15 years old took part in the clinical trial and remained at the end of the 3 months intervention program and also at the 6 months follow up. The activity intervention included a 45 minutes, three-day per week supervised training programme, that could be also attended by the parents. All adolescents were assessed for anthropometric measures, fitness and activity and family habits along with their parents.
Behavioral: Activity
All adolescents participated in a three-day per week training programme (45 minutes per training session). Training was directed by a professional teacher of physical education in a public training centre. The training program was designed according to the type and intensity of exercise that school children normally perform. Many activities were delivered as games in order to encourage enthusiasm and participation. Endurance type activities accounted for most of the time spent in training (about 50% team sports and 50% running games), with attention to coordination and flexibility skills. In order to encourage adolescents' behaviour change, they were instructed to add an extra 30-45 minutes of walking or other sport activity of their preference at least once a week and to reduce inactivity

No Intervention: Control
61 overweight and obese adolescents aged 13-15 years old were the control group of the clinical trial and remained at the end of the 3 months intervention program and also at the 6 months follow up. All adolescents were assessed for anthropometric measures, fitness and activity and family habits along with their parents.



Primary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: change from baseline at 3 months intervention program ]
    Change in BMI (kg/m2)

  2. Weight [ Time Frame: change from baseline at 3 months intervention program ]
    Change in weight (kilograms)

  3. Height [ Time Frame: change from baseline at 3 months intervention program ]
    Change in height (meters)

  4. Heart rate [ Time Frame: change from baseline at 3 months intervention program ]
    Change in heart rate (beats per minute)

  5. Blood Pressure [ Time Frame: change from baseline at 3 months intervention program ]
    Change in Blood Pressure (mm Hg)

  6. Waist circumference [ Time Frame: change from baseline at 3 months intervention program ]
    Change in waist circumference (cm)

  7. 50m sprint Run Test [ Time Frame: change from baseline at 3 months intervention program ]
    Change in 50m sprint Run Test (seconds)

  8. Family Eating and Activity Habits [ Time Frame: change from baseline at 3 months intervention program ]
    Change in <<Family Eating and Activity Habits>> (sum of the items)


Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: Change from Baseline at 6 months (follow up) ]
    Change in BMI (kg/m2)

  2. Weight [ Time Frame: Change from Baseline at 6 months (follow up) ]
    Change in weight (kilograms)

  3. Height [ Time Frame: Change from Baseline at 6 months (follow up) ]
    Change in height (meters)

  4. Heart Rate [ Time Frame: Change from Baseline at 6 months (follow up) ]
    Change in heart rate (beats per minute)

  5. Blood Pressure [ Time Frame: Change from Baseline at 6 months (follow up) ]
    Change in Blood Pressure (mm Hg)

  6. Waist circumference [ Time Frame: Change from Baseline at 6 months (follow up) ]
    Change in waist circumference (cm)

  7. 50m sprint Run Test [ Time Frame: Change from Baseline at 6 months (follow up) ]
    Change in 50m sprint Run Test (seconds)

  8. Family Eating and Activity Habits [ Time Frame: Change from Baseline at 6 months (follow up) ]
    Change in <<Family Eating and Activity Habits>> (sum of the items)



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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • None of the subjects had an organic cause for his/her obesity and
  • none received any medication, which would interfere with growth or weight control (e.g. corticosteroids, thyroid hormone).

Exclusion Criteria:

  • subjects who had an organic cause for his/her obesity
  • subjects who received any medication, which would interfere with growth or weight control

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653508


Sponsors and Collaborators
University of Thessaly
Investigators
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Study Director: Christos Hadjichristodoulou, Professor Department of Hygiene and Epidemiology Medical School - University of Thessaly

Publications of Results:
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Responsible Party: Hadjichristodoulou Christos, Professor of Hygiene and Epidemiology, University of Thessaly
ClinicalTrials.gov Identifier: NCT02653508     History of Changes
Other Study ID Numbers: obesity1uth
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  1. The data will be published
  2. The data will be given in the Ministry of Education and Religious Affairs, Sport and Culture of Greece
Keywords provided by Hadjichristodoulou Christos, University of Thessaly:
BMI: Body Mass Index
obesity
adolescents
overweight
CI:confidence interval
CDC: Center Disease Control
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms