ObesityNCT02664844
Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent
A study testing Physical activity in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Dec 2015
- 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 18 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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®).
- Conditions
- Obesity
- Being tested
- Physical activity
- Keywords
- Obesity, Appetite regulation, Insulin sensitivity, Adolescents, Exercise
- Medical subject headings
- Obesity, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Obese adolescent | Experimental | Not described Receives: Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 4 months of physical activity
Secondary outcomes (4)
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)
Measured: after 4 months of physical activity
Comparison between(M0) and (M4) of the Pittsburg scale
Measured: after 4 months of physical activity
Comparison between(M0) and (M4) of HOMA-IR
Comparison between(M0) and (M4) of HOMA-IR by measuring the blood glucose and fasting insulin
Measured: after 4 months of physical activity
Comparison between(M0) and (M4) of Fitness
Comparison between(M0) and (M4) of Fitness (by VO2 max and estimated body composition).
Measured: after 4 months of physical activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664844
- Sponsor's protocol ID
- CHU-0255
- Status last verified
- Jan 2016
- First submitted
- 15 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Food Intake Interaction: Effect of Weight Loss in Obese Adolescent
- ClinicalTrials.gov ID
- NCT02664844
- Acronym / sponsor ID
- CHU-0255
- Conditions
- Obesity
- Keywords
- Obesity, Appetite regulation, Insulin sensitivity, Adolescents, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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®).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese adolescent | Experimental | Behavioral: Physical activity |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity | Behavioural | Obese adolescent |
Primary outcome
Comparison between(M0) and (M4) of food intake on 24 hours (total and per meal)
Time frame: after 4 months of physical activity
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.
4 secondary outcomes
Comparison between(M0) and (M4) of the Flint scale
Time frame: after 4 months of physical activity
Comparison between(M0) and (M4) of the Pittsburg scale
Time frame: after 4 months of physical activity
Comparison between(M0) and (M4) of HOMA-IR
Time frame: after 4 months of physical activity
Comparison between(M0) and (M4) of Fitness
Time frame: after 4 months of physical activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 7 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Comparison between(M0) and (M4) of food intake on 24 hours (total and per meal) (time frame: after 4 months of physical activity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.