Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity. (IDEX1)

• ClinicalTrials.gov Identifier: NCT04739189
• Recruitment Status: Completed
• First Posted: February 4, 2021
• Last Update Posted: February 10, 2022
• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Tza Nou - Maison médicale pour enfants et adolescentes; Laboratoire AME2P
• Information provided by (Responsible Party): University Hospital, Clermont-Ferrand

Tracking Information

• First Submitted Date: January 27, 2021
• First Posted Date: February 4, 2021
• Last Update Posted Date: February 10, 2022
• Actual Study Start Date: August 28, 2021
• Actual Primary Completion Date: October 3, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 1, 2021)

Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal) [ Time Frame: day 1, day 8, day 15 ]

food intake will be measured ad libitum during a dinner buffet. The adolescents will be offered an ad libitum buffet-type meal composed based on their food intake preferences. Their intake will be weighted using an electronic food scale by a member of the investigation team and then analysed using Bilnuts software.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 1, 2021)

• Hunger feelings [ Time Frame: day 1, day 8, day 15 ]
  hunger area under the curve will be assessed using visual analogue scale through a the day
• Food reward [ Time Frame: day 1, day 8, day 15 ]
  The participants will be asked to complete a validated computer-based procedure to measure food reward (Leeds Food Preference Questionnaire; LFPQ)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.
• Official Title: Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.
• Brief Summary: The aim of the present study is to compare the effect of iso-energetic energy deficits induced by exercise or dietary restriction on energy intake and appetite feelings in adolescents with obesity

Detailed Description

The present study will compare the nutritional response to an energy deficit of 400 kcal induced once by realisation of an acute exercise set at moderate intensity and once by a dietary restriction imposed at lunch (compared with a control condition). 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (CON); ii) one session with an exercise-induced energy deficit (Def-EX); iii) one session with an energy restriction-induced energy deficit (Def-EI).

Their ad libitum energy intake will be assessed during dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pediatric Obesity

Intervention

• Behavioral: Con : control condition without exercise / rest condition
  Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
• Behavioral: Def-EX : Condition with an exercise-induced energy deficit
  Condition with an exercise-induced energy deficit The adolescents will be asked to complete an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 400 kcal. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
• Behavioral: Def-EI : Condition with an energy-restriction energy deficit
  Condition with an energy-restriction energy deficit The adolescents will be asked to remain quiet during the whole day (no physical activity). They will receive a calibrated breakfast reduced from 400 kcal compare to their CON and Def-EX conditions. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.

Study Arms

Experimental: Obese adolescent

Interventions:

• Behavioral: Con : control condition without exercise / rest condition
• Behavioral: Def-EX : Condition with an exercise-induced energy deficit
• Behavioral: Def-EI : Condition with an energy-restriction energy deficit

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2021): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 3, 2021
• Actual Primary Completion Date: October 3, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• BMI percentile > 97th percentile according to the french curves.
• ages 12-16 years old
• Signed consent form
• being registered in the national social security system
• no contraindication to physical activity

Exclusion Criteria:

• Previous surgical interventions that is considered as non-compatible with the study.
• Diabetes
• weight loss during the last 6 months
• cardiovascular disease or risks

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 17 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04739189
• Other Study ID Numbers: RBHP 2020 JULIAN; 2020-A03567-32 ( Other Identifier: 2020-A03567-32 )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Clermont-Ferrand
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Clermont-Ferrand
• Original Study Sponsor: Same as current

Collaborators

• Tza Nou - Maison médicale pour enfants et adolescentes
• Laboratoire AME2P

Investigators

• Principal Investigator: Valérie JULIAN; University Hospital, Clermont-Ferrand

• PRS Account: University Hospital, Clermont-Ferrand
• Verification Date: February 2022