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

August 16, 2012 updated by: Michael Lowe, Drexel University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

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

  • United States
    • Pennsylvania
      • Phildadelphia, Pennsylvania, United States, 19102
        • Drexel University

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 19 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • A variety of risk factors for later life weight gain

Exclusion Criteria:

  • Current or past history of eating disorder

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: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months
baseline, 6 weeks, 6 months, 12 months, 24 months
blood work
Time Frame: baseline, 6 months, 24 months
baseline, 6 months, 24 months
questionnaire data
Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months
baseline, 6 weeks, 6 months, 12 months, 24 months
Body Composition
Time Frame: baseline, 6 months, 24 months
baseline, 6 months, 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
dietary recalls
Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months
baseline, 6 weeks, 6 months, 12 months, 24 months
Pedometer readings
Time Frame: baseline, 6 weeks, 6 months, 12 months, 24 months
baseline, 6 weeks, 6 months, 12 months, 24 months

Collaborators and Investigators

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

Sponsor

Drexel University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Michael R Low, PhD, Drexel University

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, 2006

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 2, 2007

First Submitted That Met QC Criteria

April 2, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Estimate)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 16, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK72982
  • R01DK072982 (U.S. NIH Grant/Contract)

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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