NCT02626273

Brief Summary

The present protocol is mainly involved in the understanding of the local interaction between the released products by fat tissue and hormones production of bone tissue. These complex interactions between adipocyte and osteocyte activities could explain the mechanisms of the body responses to the strategies of weight loss that include diet and/or physical activity program, as well as the side effects encountered by these interventions. Adolescence is a period of development characterized by many metabolic and somatic changes that may influence weight. Weights bearing physical activities are a key factor allowing body composition changes (i.e. fat and bone tissue). The difficulties of managing weight and the onset of overweight and obesity during this very important growth spurt lead to various hormonal dysregulation. The specific mechanisms of the evolution and interactions between these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to analyze the possible connections between fat tissue and the quality of the skeleton in order to reduce related risks of the consequence of weight loss in obese individuals.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

1.1 years

First QC Date

November 3, 2015

Last Update Submit

July 28, 2016

Conditions

Obesity

Keywords

obesityadolescentsphysical activityadipocytesosteocytesweight lossbonefat

Outcome Measures

Primary Outcomes (2)

  • change from baseline fat mass measured by Dual energy X-ray Absorptiometry (DXA)

    at 10 months.

  • change from baseline bone mass measured by Dual energy X-ray Absorptiometry (DXA)

    at 10 months

Secondary Outcomes (24)

  • Whole body measured by Dual energy X-ray Absorptiometry (DXA)

    at 10 months

  • weight waist

    at 10 months.

  • waist circumference

    at 10 months.

  • lower limb bone lengths

    at 10 months.

  • Physical activity measured with International Physical Activity Questionnaire

    at 10 months.

  • +19 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

an intervention group who will undergo the management program combining physical activity and restrictive diet at Tza Nou Medical House for 10 months

Radiation: weight loss

a control group

OTHER

a control group who will not undergo any intervention

Radiation: weight loss

Interventions

weight lossRADIATION
a control groupintervention group

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All adolescent girls will have to be free of any recent history of hospitalization (past two years) or of systemic illness lasting more than two weeks in the past 12 months. .

You may not qualify if:

  • pregnant girl
  • diabetes
  • insulin-resistance
  • hypo or hyper-thyroid
  • consuming alcohol
  • smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • Chaplais E, Dutheil F, Naughton G, Greene D, Pereira B, Thivel D, Courteix D. Cross-sectional and longitudinal study protocols of the 'ADIposity and BOne metabolism: effects of eXercise-induced weight loss in obese adolescents' (ADIBOX) project. BMJ Open. 2016 Oct 18;6(10):e011407. doi: 10.1136/bmjopen-2016-011407.

    PMID: 27797988DERIVED

MeSH Terms

Conditions

ObesityMotor ActivityWeight LossPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBody Weight Changes

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2015

First Posted

December 10, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

FR(1)