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

Study Overview
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Brief Summary
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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.

Detailed Description
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Study design: All students from the 15 public middle schools in the city of Larissa in central Greece were invited to measure their weight and height, in order to calculate their Body Mass Index (BMI). All the overweight or obese students were invited to take part in the study. The participation was free of charge for the children. Parents were informed about the purposes of the project and were asked to provide written informed consent for participation. The study's protocol was approved by the ethics committee of the Medical Department of the University of Thessaly. One hundred eighty one adolescents were enrolled and randomized in the three groups of the study, by the same professional teacher of physical education who conducted the program. One hundred fifty remained the end of the program and the 6-months follow up and were included in the analysis. 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). Intervention: The FETA project involved one control and two intervention groups: a Physical Activity Skill Development Program (Activity) and a combination of a Dietary Information and a Physical Activity Skill Development Program (Diet and Activity). Physical Activity Skill Development Program: 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 (discouraging television watching and playing video games and encouraging the use of stairs instead of lifts and playing outdoors). Structured nutrition education: Additionally, to the training sessions, the participants of the combined intervention attended a structure nutrition educational program. In the introductory meeting (45-60 minutes) general information was presented about the reasons behind childhood obesity, dietary and cooking habits and the motivation for weight loss in an effort to involve the whole family in the ''battle'' against obesity. 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. The topics discussed were given to the adolescents in the form of a printed notebook, while parents were also invited to attend these sessions. The discussions were led by the same person who performed the training session. Outcome measures: All the outcomes measures were taken at baseline and every month until the end of the sixth month, when the 3-month follow up period after the intervention ended. Anthropometric measurements: Students were weighed on a digital scale twice and the average was recorded. Participants removed shoes and jackets before heights and weights were measured. Participants' heights were measured using a metric measuring tape affixed on the wall. Body weight and height were measured using the same instruments, at the same place and day of the week, before the start of the day's program. Non-extensible steel tapes were used to assess waist circumference, which was measured at the level of the mid point between the lower costal border and the iliac crest. All the anthropometric measures were conducted using the International Society for the Advancement of Kin anthropometry procedures. BMI was determined according to the following formula: BMI= [weight/height2]. We used the cut off points for the BMI in childhood presented by Cole et al in order to allow international comparisons with our findings in the prevalence of overweight and obesity. Pulses per minute were measured using an automated blood pressure monitor under standardised procedures. Fitness assessment: Pre- and post- intervention evaluations (at 3 and 6 months) of physical fitness were based on the EUROFIT Tests Protocol designed by the Committee of Experts on Sports Research that has been used in several European countries. The 50m sprint Run Test that was used is a test for the evaluation of speed. Family Eating and Activity Habits Questionnaire: The modified version of the Family Eating and Activity Habits Questionnaire (FEAHQ) was completed by parents and adolescents. FEAHQ is divided into four subscales: activity level (4 items), stimulus exposure (8 items), eating related to hunger (4 items), and eating style (13 items). Blinding: The randomized adolescents in each group were not aware of the existence of the other two study groups. This was achievable by programming the attendance of each group at different hours, even on the same days. Moreover their parents were also unaware of the study's design. Finally, all the participants from each of the three groups- both adolescents and parents- were asked not to discuss their study experience until the completion of the follow up, at 6-months from the initiation of the study.

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

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Diet and Activity
* Behavioral: Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet and Activity<br>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<br>* 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.<br>|
| Experimental: Activity<br>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<br>* 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<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | Change in BMI (kg/m2) | change from baseline at 3 months intervention program | 
| Weight | Change in weight (kilograms) | change from baseline at 3 months intervention program | 
| Height | Change in height (meters) | change from baseline at 3 months intervention program | 
| Heart rate | Change in heart rate (beats per minute) | change from baseline at 3 months intervention program | 
| Blood Pressure | Change in Blood Pressure (mm Hg) | change from baseline at 3 months intervention program | 
| Waist circumference | Change in waist circumference (cm) | change from baseline at 3 months intervention program | 
| 50m sprint Run Test | Change in 50m sprint Run Test (seconds) | change from baseline at 3 months intervention program | 
| Family Eating and Activity Habits | Change in <<Family Eating and Activity Habits>> (sum of the items) | change from baseline at 3 months intervention program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | Change in BMI (kg/m2) | Change from Baseline at 6 months (follow up) | 
| Weight | Change in weight (kilograms) | Change from Baseline at 6 months (follow up) | 
| Height | Change in height (meters) | Change from Baseline at 6 months (follow up) | 
| Heart Rate | Change in heart rate (beats per minute) | Change from Baseline at 6 months (follow up) | 
| Blood Pressure | Change in Blood Pressure (mm Hg) | Change from Baseline at 6 months (follow up) | 
| Waist circumference | Change in waist circumference (cm) | Change from Baseline at 6 months (follow up) | 
| 50m sprint Run Test | Change in 50m sprint Run Test (seconds) | Change from Baseline at 6 months (follow up) | 
| Family Eating and Activity Habits | Change in <<Family Eating and Activity Habits>> (sum of the items) | Change from Baseline at 6 months (follow up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI: Body Mass Index, obesity, adolescents, overweight, CI:confidence interval, CDC: Center Disease Control