NCT00995462

Brief Summary

This study assess whether a small-group seminar intervention to prevent weight gain is effective in a general university student population, and to address the relative role of biological vs. lifestyle factors in predicting weight gain in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
319

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 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, 2006

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

5.1 years

First QC Date

October 14, 2009

Last Update Submit

December 10, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight change

    2 years

Study Arms (3)

Control

NO INTERVENTION

Small-group seminar for 2 years

EXPERIMENTAL
Behavioral: Lifestyle intervention seminars

Small-group seminars for 1 year followed by email intervention

EXPERIMENTAL
Behavioral: Lifestyle intervention seminars

Interventions

The first sessions emphasize acquisition of new knowledge during interactive group seminars designed to maximize attendant's participation by adapting wellknown quiz-show or parlour games to deliver key concepts. A number of sessions are aimed at increasing self-efficacy through problem-solving, time-management strategies, individual self monitoring and goal-setting.During the second year, the intervention focuses on maintenance of healthy behaviour with empowerment of the participants using problem-solving, goal-setting, planning, and self-monitoring skills.

Small-group seminar for 2 yearsSmall-group seminars for 1 year followed by email intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First year students at the Université de Sherbrooke.

You may not qualify if:

  • Presence of diseases or medications that would be expected to affect weight (cystic fibrosis, diabetes, inflammatory bowel diseases, anorexia nervosa, bulimia, etc.).
  • Pregnancy or planning a pregnancy in the next two years.
  • Unable to give an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1K 2R1, Canada

Location

Related Publications (1)

  • Langlois F, Langlois MF, Carpentier AC, Brown C, Lemieux S, Hivert MF. Ghrelin levels are associated with hunger as measured by the Three-Factor Eating Questionnaire in healthy young adults. Physiol Behav. 2011 Sep 1;104(3):373-7. doi: 10.1016/j.physbeh.2011.04.013. Epub 2011 Apr 22.

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie-France Langlois, MD

    Université de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

September 1, 2006

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations