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ObesityFETANCT02653508

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

A study testing Diet and Activity and Activity in people with Obesity, run by University of Thessaly.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Diet and Activity and Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
No sites listed yet
Study dates
Sep 2011to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

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

About this study

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.

Read the 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.

Conditions
Obesity
Being tested
Diet and Activity, Activity
Keywords
BMI: Body Mass Index, obesity, adolescents, overweight, CI:confidence interval, CDC: Center Disease Control
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet and ActivityBehavioural

    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.

  • ActivityBehavioural

    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

Study groups in NCT02653508
Study groupRoleWhat they receive
Diet and ActivityExperimental60 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.
Receives: Behavioral: Diet and Activity
ActivityExperimental60 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.
Receives: Behavioral: Activity
ControlNo intervention61 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index (BMI)

    Change in BMI (kg/m2)

    Measured: change from baseline at 3 months intervention program

  2. Weight

    Change in weight (kilograms)

    Measured: change from baseline at 3 months intervention program

  3. Height

    Change in height (meters)

    Measured: change from baseline at 3 months intervention program

  4. Heart rate

    Change in heart rate (beats per minute)

    Measured: change from baseline at 3 months intervention program

  5. Blood Pressure

    Change in Blood Pressure (mm Hg)

    Measured: change from baseline at 3 months intervention program

  6. Waist circumference

    Change in waist circumference (cm)

    Measured: change from baseline at 3 months intervention program

  7. 50m sprint Run Test

    Change in 50m sprint Run Test (seconds)

    Measured: change from baseline at 3 months intervention program

  8. Family Eating and Activity Habits

    Change in <<Family Eating and Activity Habits>> (sum of the items)

    Measured: change from baseline at 3 months intervention program

Secondary outcomes (8)
  1. Body Mass Index (BMI)

    Change in BMI (kg/m2)

    Measured: Change from Baseline at 6 months (follow up)

  2. Weight

    Change in weight (kilograms)

    Measured: Change from Baseline at 6 months (follow up)

  3. Height

    Change in height (meters)

    Measured: Change from Baseline at 6 months (follow up)

  4. Heart Rate

    Change in heart rate (beats per minute)

    Measured: Change from Baseline at 6 months (follow up)

  5. Blood Pressure

    Change in Blood Pressure (mm Hg)

    Measured: Change from Baseline at 6 months (follow up)

  6. Waist circumference

    Change in waist circumference (cm)

    Measured: Change from Baseline at 6 months (follow up)

  7. 50m sprint Run Test

    Change in 50m sprint Run Test (seconds)

    Measured: Change from Baseline at 6 months (follow up)

  8. Family Eating and Activity Habits

    Change in <<Family Eating and Activity Habits>> (sum of the items)

    Measured: Change from Baseline at 6 months (follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2016 (estimated)
  2. Study startSep 2011
  3. Primary completionApr 2012
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02653508
Sponsor's protocol ID
obesity1uth
Acronym
FETA
Status last verified
Jan 2016
First submitted
17 Dec 2015
Last updated
12 Jan 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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

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.

    PubMed 25858615
  • 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.

    PubMed 26195970
  • 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.

    PubMed 20447648
  • 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.

    PubMed 21984691
  • 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.

    PubMed 10048106

Questions about this trial

What is this clinical trial studying?

A study testing Diet and Activity and Activity in people with Obesity, run by University of Thessaly.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (BMI) (time frame: change from baseline at 3 months intervention program). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02653508, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.

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