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

NCT02653508 | Completed

• 1 other identifier: obesity1uth
• Study Type: interventional
• Target: 181
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

BMI: Body Mass Index; obesity; adolescents; overweight; CI:confidence interval; CDC: Center Disease Control

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• Body Mass Index (BMI)

  Change from Baseline at 6 months (follow up)

• Weight

  Change from Baseline at 6 months (follow up)

• Height

  Change from Baseline at 6 months (follow up)

• Heart Rate

  Change from Baseline at 6 months (follow up)

• Blood Pressure

  Change from Baseline at 6 months (follow up)

Study Arms (3)

Diet and Activity

EXPERIMENTAL

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

Activity

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Diet and Activity BEHAVIORAL

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.

Diet and Activity

Activity BEHAVIORAL

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

Activity

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Thessaly: lead

Related Publications (5)

• 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.

  PMID: 25858615 RESULT

• 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.

  PMID: 26195970 RESULT

• 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.

  PMID: 20447648 RESULT

• 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.

  PMID: 21984691 RESULT

• 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.

  PMID: 10048106 RESULT

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christos Hadjichristodoulou, Professor

  Department of Hygiene and Epidemiology Medical School - University of Thessaly

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hygiene and Epidemiology

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: January 12, 2016
• Study Start: September 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: September 1, 2014
• Last Updated: January 12, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share