Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
110 participants
INTERVENTIONAL
2002-09-30
2005-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hypothesis : We hypothesize that a small group seminar-based educational intervention on healthy lifestyle may prevent weight gain in young healthy adults.
PROTOCOL:
Recrutment of participants : First and second year students will be recruted at the 'Faculté de médecine et des sciences de la santé' of the University of Sherbrooke.
A pre-randomisation visit will be performed to verify eligibility and exclusion criteria and to perform the following:
* Anthropometric measurements (please, see below);
* medical questionnaire;
* physical exam;
* standard questionnaire on dietary and physical activity habits;
* Canadian fitness test (to estimate VO2 max)(www.ecoledudos.uqat.uquebec.ca/chroniquep/03preparationphysique/evaluer/#physitest);
* A fasting blood sample to mesure plasma glucose, insulin, plasma lipids. Serum samples will be stored at -80C for future analyses (adipokines, inflammation markers).
Randomisation: Block randomization according to gender and tertile of BMI of each participant to either the control (no intervention) or intervention (small group seminars) group will be performed once the entire cohort will be recruited at the beginning of the academic year using computer-generated numbers. One investigator will enroll all the study participants and another that will have no contact with the participants will generate the allocation sequence.
Measurements :
A standard questionnaire will be administered to collect the following data: gender, age, study program, medical history, and physical exam results.
Anthropometric measures will be performed at baseline and 3, 6, 12, 18 and 24 months and include:
* Weight (kg),
* height (m) (by standing stadiometre- mean of three measures),
* Waist circumference (cm) (midway between iliac crest and last rib end of a normal expiration - mean of 3 measures),
* lean mass by electrical bio-impedance.
Recording of physical activity : Using a standard questionnaire (Sallis JF et al. Am J Epidemiol 1985;121:91-106) (reported in METs) and performed at 0, 12 and 24 months.
Recording of dietary habits : Standard 3-day food record at 0, 12 and 24 months.
Physical fitness (VO2 max): Canadian Home Fitness Test at 0, 12 and 24 months.
Blood samples (60 ml) at 0 and 24 months: Plasma (15 ml) and serum (15 ml) will be collected after a 8 to 12 hour fast to measure blood glucose; total cholesterol, HDL-cholesterol, total triglycerides (with calculation of LDL-c using the Friedwal formula). Samples will be stored at -80C for future determination of plasma insulin, adipokines and serum inflammatory markers. These analyses will allow us to explore the relationship between weight gain and change in these biological parameters in our study population and to determine whether prevention of weight gain may also be associated with early prevention of metabolic abnormalities associated with obesity.
Intervention:
Small group seminars (10 to 12 students) in the treatment group vs. no specific intervention (other than measurements described above) in the control group. The duration of seminars will be approximatively 30 to 60 minutes and will be given every two weeks for the first two months of follow up and every four weeks for the remaining follow up period, except for summer break (July and August) when seminars will not be given. A multidisciplinary team including endocrinologists, a physical education specialist and a dietician designed the seminars that will be delivered by an endocrinology resident and a physical education graduate student. The first three seminars will be aimed at increasing knowledge on weight gain and its complications, national dietary recommendations (Canadian Food Guide) and exercise categories, expected benefits and recommendations for the maintenance of health. The remaining seminars will be designed to introduce behavioral modification methods using discussion on problem-solving, goal-setting and monitoring strategies. Some seminars will focus on behavioral strategies to maintain a healthy lifestyle during specific periods such as final exams, holidays, winter and vacations. The monitors themselves as well as older students successful at keeping an active lifestyle will be offered as role models to promote a positive image of a healthy lifestyle. Compliance with the intervention will be defined as attending at least 60% of the seminars.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Small group seminar-based educational intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged between 18 and 30 years old
* BMI between 18 and 30 kg/m2
* Having left parental house less than one year ago
Exclusion Criteria
* 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.
18 Years
30 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Université de Sherbrooke
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
André C. Carpentier, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Centre de recherche clinique du Centre hospitalier universitaire de Sherbrooke
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre de recherche clinique du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
02-48
Identifier Type: -
Identifier Source: org_study_id