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

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ClinicalTrials.gov Identifier: NCT00456131
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : August 17, 2012
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Michael Lowe, Drexel University

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Behavioral: Healthy Eating Behaviors Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : September 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Weight [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ]
  2. blood work [ Time Frame: baseline, 6 months, 24 months ]
  3. questionnaire data [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ]
  4. Body Composition [ Time Frame: baseline, 6 months, 24 months ]

Secondary Outcome Measures :
  1. dietary recalls [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ]
  2. Pedometer readings [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ]


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Ages Eligible for Study:   18 Years to 19 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456131


Locations
United States, Pennsylvania
Drexel University
Phildadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Drexel University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Michael R Low, PhD Drexel University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Lowe, Principal Investigator, Drexel University
ClinicalTrials.gov Identifier: NCT00456131     History of Changes
Other Study ID Numbers: DK72982
R01DK072982 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: August 17, 2012
Last Verified: August 2012

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