Clinical trial NCT02653508: Evaluating the Efficacy of the Feeding Exercise Trial in Adolescents (FETA Project) in Central Greece
Official title: Evaluating the Efficacy of the Feeding Exercise Trial in Adolescents (FETA Project) in Central Greece
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: BMI: Body Mass Index
obesity
adolescents
overweight
CI:confidence interval
CDC: Center Disease Control
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 181
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Detailed description: 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.

1. 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.
2. 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.
3. 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.

Eligibility 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

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: change from baseline at 3 months intervention program
measure: Weight
timeFrame: change from baseline at 3 months intervention program
measure: Height
timeFrame: change from baseline at 3 months intervention program
measure: Heart rate
timeFrame: change from baseline at 3 months intervention program
measure: Blood Pressure
timeFrame: change from baseline at 3 months intervention program
measure: Waist circumference
timeFrame: change from baseline at 3 months intervention program
measure: 50m sprint Run Test
timeFrame: change from baseline at 3 months intervention program
measure: Family Eating and Activity Habits
timeFrame: change from baseline at 3 months intervention program
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: Change from Baseline at 6 months (follow up)
measure: Weight
timeFrame: Change from Baseline at 6 months (follow up)
measure: Height
timeFrame: Change from Baseline at 6 months (follow up)
measure: Heart Rate
timeFrame: Change from Baseline at 6 months (follow up)
measure: Blood Pressure
timeFrame: Change from Baseline at 6 months (follow up)
measure: Waist circumference
timeFrame: Change from Baseline at 6 months (follow up)
measure: 50m sprint Run Test
timeFrame: Change from Baseline at 6 months (follow up)
measure: Family Eating and Activity Habits
timeFrame: Change from Baseline at 6 months (follow up)
Other outcomes:
Locations:
Study officials:
affiliation: Department of Hygiene and Epidemiology Medical School - University of Thessaly
name: Christos Hadjichristodoulou, Professor
role: STUDY_DIRECTOR
References:
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