- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02496637
A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen
October 9, 2018 updated by: University of Minnesota
A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen: A Randomized Clinical Trial
The proposed study is a randomized clinical trial investigating the effects of a weight gain and eating dysregulation prevention intervention among college freshmen women.
It will compare Appetite Awareness Training (AAT) to a standard nutritional education group and a no treatment control group.
Appetite Awareness Training approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All female freshmen students residing in the university dorms were recruited to participate in this study.
After completing the baseline assessment, eligible participants were randomly assigned to one of the three arms.
Those in the AAT condition received guided administration of AAT over the course of three weekly group sessions, with an additional booster session three weeks after completion (week 6).
The standard treatment comparison group received four similarly timed group sessions of psychoeducational/nutrition information facilitated by a registered dietician.
A manualized approach to administration of the intervention was created based on the AAT treatment and was strictly followed in order to standardize the implementation of the prevention groups.
The no-treatment control group only participated in the assessments.
Study Type
Interventional
Enrollment (Actual)
130
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
-
-
Minnesota
-
Duluth, Minnesota, United States, 55812
- University of Minnesota Duluth
-
-
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 20 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Incoming University of Minnesota Duluth freshmen women residing in on campus dormitories
Exclusion Criteria:
- Males, non-dormitory residing, non-freshmen.
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: Appetite Awareness
Appetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues
|
Appetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues
|
Active Comparator: Nutrition Education
Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.
|
Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.
|
No Intervention: No Treatment Control
No intervention, assessment only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Body Weight measured in pounds
Time Frame: Baseline, 6 weeks, 4 months
|
Baseline, 6 weeks, 4 months
|
Change in Appetite Awareness as assessed by the Interoceptive Awareness Questionnaire (appetite subscale)
Time Frame: Baseline, 6 weeks, 4 months
|
Baseline, 6 weeks, 4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Body Image as assessed by the Satisfaction and Dissatisfaction with Body Parts Scale
Time Frame: 6 weeks, 4 months
|
6 weeks, 4 months
|
Change in Weight Management self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire
Time Frame: 6 weeks, 4 months
|
6 weeks, 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
August 1, 2015
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
July 6, 2015
First Submitted That Met QC Criteria
July 9, 2015
First Posted (Estimate)
July 14, 2015
Study Record Updates
Last Update Posted (Actual)
October 11, 2018
Last Update Submitted That Met QC Criteria
October 9, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1506S74643
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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