NCT00456131

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 17, 2012

Status Verified

August 1, 2012

Enrollment Period

4.4 years

First QC Date

April 2, 2007

Last Update Submit

August 16, 2012

Conditions

Outcome Measures

Primary Outcomes (4)

  • Weight

    baseline, 6 weeks, 6 months, 12 months, 24 months

  • blood work

    baseline, 6 months, 24 months

  • questionnaire data

    baseline, 6 weeks, 6 months, 12 months, 24 months

  • Body Composition

    baseline, 6 months, 24 months

Secondary Outcomes (2)

  • dietary recalls

    baseline, 6 weeks, 6 months, 12 months, 24 months

  • Pedometer readings

    baseline, 6 weeks, 6 months, 12 months, 24 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 19 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A variety of risk factors for later life weight gain

You may not qualify if:

  • Current or past history of eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Phildadelphia, Pennsylvania, 19102, United States

Location

Related Publications (2)

  • Lowe MR, Feig EH, Winter SR, Stice E. Short-term variability in body weight predicts long-term weight gain. Am J Clin Nutr. 2015 Nov;102(5):995-9. doi: 10.3945/ajcn.115.115402. Epub 2015 Sep 9.

  • Berner LA, Arigo D, Mayer LE, Sarwer DB, Lowe MR. Examination of central body fat deposition as a risk factor for loss-of-control eating. Am J Clin Nutr. 2015 Oct;102(4):736-44. doi: 10.3945/ajcn.115.107128. Epub 2015 Sep 9.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael R Low, PhD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 4, 2007

Study Start

September 1, 2006

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 17, 2012

Record last verified: 2012-08

Locations