NCT00306449

Brief Summary

The purpose of the present study is to determine whether weight gain may be prevented by a small group seminar-based two-year educational intervention on healthy lifestyle in freshmen at the Faculté de médecine de l'Université de Sherbrooke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2002

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
Last Updated

March 23, 2006

Status Verified

March 1, 2006

First QC Date

March 21, 2006

Last Update Submit

March 21, 2006

Conditions

Keywords

Weight gainobesityoverweightyoung adultslipid disordersinsulin resistancerandomized controled study

Outcome Measures

Primary Outcomes (2)

  • Change in weight from baseline between the two groups over a two-year intervention period (0, 3, 6, 12, 18 and 24 months).

  • Change in BMI from baseline between the two groups over a two-year intervention period (0, 3, 6, 12, 18 and 24 months).

Secondary Outcomes (11)

  • Change in fat free mass (by bioimpedance) over follow up between the two groups.

  • Change in waist circumference over follow up between the two groups.

  • Change in non-fat free mass over follow up between the two groups.

  • Change in dietary intake (by 3-day food records) over follow up between the two groups.

  • Change in physical activity level (by questionnaire) over follow up between the two groups.

  • +6 more secondary outcomes

Interventions

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being first or second year in one of the Baccalaureate programs of the Faculté de médecine de l'Université de Sherbrooke.
  • Aged between 18 and 30 years old
  • BMI between 18 and 30 kg/m2
  • Having left parental house less than one year ago

You may not qualify if:

  • Planned pregnancy or pregnancy occurring during the two-year follow up
  • Chronic medical condition that may affect weight present before or occurring during the two-year follow up.
  • Use of any medication other than birth control pills.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche clinique du Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

  • Hivert MF, Langlois MF, Berard P, Cuerrier JP, Carpentier AC. Prevention of weight gain in young adults through a seminar-based intervention program. Int J Obes (Lond). 2007 Aug;31(8):1262-9. doi: 10.1038/sj.ijo.0803572. Epub 2007 Mar 13.

MeSH Terms

Conditions

Weight GainObesityOverweightLipid Metabolism DisordersInsulin Resistance

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic DiseasesMetabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • André C. Carpentier, MD FRCPC

    Centre de recherche clinique du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 23, 2006

Study Start

September 1, 2002

Study Completion

September 1, 2005

Last Updated

March 23, 2006

Record last verified: 2006-03

Locations