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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02496637
Other study ID # 1506S74643
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date October 1, 2017

Study information

Verified date October 2018
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 130
Est. completion date October 1, 2017
Est. primary completion date October 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 20 Years
Eligibility Inclusion Criteria:

- Incoming University of Minnesota Duluth freshmen women residing in on campus dormitories

Exclusion Criteria:

- Males, non-dormitory residing, non-freshmen.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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
Nutrition Education
Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.

Locations

Country Name City State
United States University of Minnesota Duluth Duluth Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Body Weight measured in pounds Baseline, 6 weeks, 4 months
Primary Change in Appetite Awareness as assessed by the Interoceptive Awareness Questionnaire (appetite subscale) Baseline, 6 weeks, 4 months
Secondary Change in Body Image as assessed by the Satisfaction and Dissatisfaction with Body Parts Scale 6 weeks, 4 months
Secondary Change in Weight Management self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire 6 weeks, 4 months
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