Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306449
Status:
COMPLETED
Last Update Posted:
2006-03-23
First Post:
2006-03-21
Brief Title:
Prevention of Weight Gain in Young Adults
Sponsor:
Université de Sherbrooke
Organization:
Université de Sherbrooke
Study Overview
Official Title:
Prevention of Weight Gain in Young Adults
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 lUniversité de Sherbrooke
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 maxwwwecoledudosuqatuquebeccachroniquep03preparationphysiqueevaluerphysitest
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 198512191-106 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
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 maxwwwecoledudosuqatuquebeccachroniquep03preparationphysiqueevaluerphysitest
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 198512191-106 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None