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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Further study details as provided by Michael Lowe, Drexel University:

Primary Outcome Measures:
  • Weight [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ]
  • blood work [ Time Frame: baseline, 6 months, 24 months ]
  • questionnaire data [ Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months ]
  • Body Composition [ Time Frame: baseline, 6 months, 24 months ]

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

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   (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
  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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Michael R Low, PhD Drexel University
  More Information

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 )
Study First Received: April 2, 2007
Last Updated: August 16, 2012

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

ClinicalTrials.gov processed this record on June 29, 2017