Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent

Obesity Clinical Trial

Official title:

Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664844
• Other study ID #: CHU-0255
• Status: Completed
• Phase: N/A
• First received: January 15, 2016
• Last updated: January 22, 2016
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

In obese adolescents, energy expenditure (EE) of chronic high intensity muscular exercise (> 70% VO2max) conducted one hour before a meal causes an anorectic effect at lunch and dinner the same day. The effect on food intake of the distribution of this exercise into two sessions during 24h remains to be determined. In addition, a multidisciplinary load of obesity generates a loss of body weight in the short term, which we do not know the effects on energy balance. To our knowledge, the impact of weight loss on the anorectic effect of muscle exercise is unknown.

Description:

Two measuring sequences will be carried out before (M0) and after 4 months (M4) of a multidisciplinary treatment program of four months. Each sequence will have three days: a "sedentary" day (SED) and two days "exercise" (EX). During the exercise day "EX1", a continuous intense exercise will be conducted for 40 min at 70% VO2max of subjects. During the second day exercise "EX2" teenage realize two exercise representing the same DE as EX1 in the morning (50% ED) and late afternoon (50% ED). The multidisciplinary management program (without energy restriction) controlled by institution consists of nutrition education, physical activity and therapeutic education. The exercise program will involve the activity sessions controlled and supervised by a sports educator and interactive sessions using a scientifically validated physical activity program (Biomouv®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Overweight adolescents (over the 90 th percentile of the international cut-off point)

• Sedentary (according to the IPAQ-A questionnaire)

• Without eating disorders (according to the DEBQ questionnaire)

Exclusion Criteria:

• Medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease.

• Drugs that could interfere with the results of the study

• Surgical intervention in the 3 months

• Regular consumption of tobacco or Alcohol

• patients on a diet with caloric restriction

• Refusal to sign the consent form

• Regular practice of sport and intensive

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Physical activity

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between(M0) and (M4) of food intake on 24 hours (total and per meal)	Comparison between(M0) and (M4) of food intake on 24 hours (total and per meal) assessed during a day with the completion of intense exercise performed in one session EX1, in two sessions (EX2) or sedentary (without exercise: SED). The exercise-induced energy expenditure by 40 minutes at 70% of VO2 max is the same in EX1 and EX2.	after 4 months of physical activity	No
Secondary	Comparison between(M0) and (M4) of the Flint scale	Comparison between(M0) and (M4) of the Flint scale (feeling of hunger, desire to eat, the feeling of being full)	after 4 months of physical activity	No
Secondary	Comparison between(M0) and (M4) of the Pittsburg scale		after 4 months of physical activity	No
Secondary	Comparison between(M0) and (M4) of HOMA-IR	Comparison between(M0) and (M4) of HOMA-IR by measuring the blood glucose and fasting insulin	after 4 months of physical activity	No
Secondary	Comparison between(M0) and (M4) of Fitness	Comparison between(M0) and (M4) of Fitness (by VO2 max and estimated body composition).	after 4 months of physical activity	No