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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Diet and Activity; Behavioral: Activity

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.

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Menghetti E, Strisciuglio P, Spagnolo A, Carletti M, Paciotti G, Muzzi G, Beltemacchi M, Concolino D, Strambi M, Rosano A. Hypertension and obesity in Italian school children: The role of diet, lifestyle and family history. Nutr Metab Cardiovasc Dis. 2015 Jun;25(6):602-7. doi: 10.1016/j.numecd.2015.02.009. Epub 2015 Mar 2.
• Shikha D, Singla M, Walia R, Potter N, Umpaichitra V, Mercado A, Winer N. Ambulatory Blood Pressure Monitoring in Lean, Obese and Diabetic Children and Adolescents. Cardiorenal Med. 2015 Jun;5(3):183-90. doi: 10.1159/000381629. Epub 2015 Apr 30.
• Okely AD, Collins CE, Morgan PJ, Jones RA, Warren JM, Cliff DP, Burrows TL, Colyvas K, Steele JR, Baur LA. Multi-site randomized controlled trial of a child-centered physical activity program, a parent-centered dietary-modification program, or both in overweight children: the HIKCUPS study. J Pediatr. 2010 Sep;157(3):388-94, 394.e1. doi: 10.1016/j.jpeds.2010.03.028. Epub 2010 May 6.
• Hendrie GA, Brindal E, Corsini N, Gardner C, Baird D, Golley RK. Combined home and school obesity prevention interventions for children: what behavior change strategies and intervention characteristics are associated with effectiveness? Health Educ Behav. 2012 Apr;39(2):159-71. doi: 10.1177/1090198111420286. Epub 2011 Oct 7.
• Manios Y, Moschandreas J, Hatzis C, Kafatos A. Evaluation of a health and nutrition education program in primary school children of Crete over a three-year period. Prev Med. 1999 Feb;28(2):149-59. doi: 10.1006/pmed.1998.0388.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 8, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: obesity; overweight; adolescents; BMI: Body Mass Index; CI:confidence interval; CDC: Center Disease Control
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: obesity1uth

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data will be published; The data will be given in the Ministry of Education and Religious Affairs, Sport and Culture of Greece