Weight GainNCT00306449
Prevention of Weight Gain in Young Adults
A study testing Small group seminar-based educational intervention in people with Weight Gain and Obesity, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Obesity, Overweight
- What is being tested?
- Small group seminar-based educational intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2002to Sep 2005
- Phase
- Interventional
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche clinique du Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
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.
Read the detailed description
This is a 2-year randomized, controlled intervention study to test the effectiveness of a small group seminar-based educational intervention on healthy lifestyle to prevent weight gain in young healthy university students.
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
- Weight Gain, Obesity, Overweight
- Being tested
- Small group seminar-based educational intervention
- Keywords
- Weight gain, obesity, overweight, young adults, lipid disorders, insulin resistance, randomized controled study
- Medical subject headings
- Weight Gain, Obesity, Overweight, Lipid Metabolism Disorders, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small group seminar-based educational interventionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Change in physical fitness level (by the Canadian Home Fitness Test) over follow up between the two groups.
Change in plasma lipid profile (plasma total cholesterol, triglycerides, LDL and HDL cholesterol) over follow up between the two groups.
Change in circulating hormones and inflammatory markers (insulin, leptin, adiponectin, C-reactive protein, Interleukin-6) over follow up between the two groups.
Relation between change in weight and energy intake and expense in the overall cohort.
Relation between change in weight and fitness level in the overall cohort.
Relation between change in weight and metabolic parameters (lipids, hormones and inflammatory markers) in the overall cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startSep 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Investigators
- André C. Carpentier, MD FRCPC, Principal investigator, Centre de recherche clinique du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306449
- Sponsor's protocol ID
- 02-48
- Status last verified
- Mar 2006
- First submitted
- 21 Mar 2006
- Last updated
- 23 Mar 2006
- Results posted
- No
Publications
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.
PubMed 17356531