Prevention of Weight Gain in Young Adults

March 21, 2006 updated by: Université de Sherbrooke
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre de recherche clinique du Centre hospitalier universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Investigators

  • Principal Investigator: André C. Carpentier, MD FRCPC, Centre de recherche clinique du Centre hospitalier universitaire de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimate)

March 23, 2006

Study Record Updates

Last Update Posted (Estimate)

March 23, 2006

Last Update Submitted That Met QC Criteria

March 21, 2006

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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