Prevention of Obesity at Universities: A Randomized Trial (Healthy Start)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Lowe, Drexel University
ClinicalTrials.gov Identifier:
NCT00456131
First received: April 2, 2007
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

This is a nutrition and behavior-based intervention conducted at Drexel University and the University of Pennsylvania with college women during their freshman year. It involves attending groups where life skills and eating behaviors are taught to help them control their weight and physical health.


Condition Intervention
Obesity
Behavioral: Healthy Eating Behaviors Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Weight [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • blood work [ Time Frame: baseline, 6 months, 24 months ] [ Designated as safety issue: No ]
  • questionnaire data [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Body Composition [ Time Frame: baseline, 6 months, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • dietary recalls [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Pedometer readings [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: September 2006
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
The intervention group (other group is a control without any intervention) involves 6 one-hour group sessions teaching healthy eating habits and weight gain prevention tools.
Behavioral: Healthy Eating Behaviors Training
The intervention group (other group is a control without any intervention) involves 6 one-hour group sessions teaching healthy eating habits and weight gain prevention tools.

  Eligibility

Ages Eligible for Study:   18 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A variety of risk factors for later life weight gain

Exclusion Criteria:

  • Current or past history of eating disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456131

Locations
United States, Pennsylvania
Drexel University
Phildadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
Investigators
Principal Investigator: Michael R Low, PhD Drexel University
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Lowe, Principal Investigator, Drexel University
ClinicalTrials.gov Identifier: NCT00456131     History of Changes
Other Study ID Numbers: DK72982, R01DK072982
Study First Received: April 2, 2007
Last Updated: August 16, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014