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A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen

Primary Purpose

Obesity, Eating Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Appetite Awareness
Nutrition Education
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Eating Disorders, Appetite regulation, Eating Regulation

Eligibility Criteria

18 Years - 20 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Minnesota Duluth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Appetite Awareness

Nutrition Education

No Treatment Control

Arm Description

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 provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.

No intervention, assessment only

Outcomes

Primary Outcome Measures

Change in Body Weight measured in pounds
Change in Appetite Awareness as assessed by the Interoceptive Awareness Questionnaire (appetite subscale)

Secondary Outcome Measures

Change in Body Image as assessed by the Satisfaction and Dissatisfaction with Body Parts Scale
Change in Weight Management self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire

Full Information

First Posted
July 6, 2015
Last Updated
October 9, 2018
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02496637
Brief Title
A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen
Official Title
A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Eating Disorders
Keywords
Obesity, Eating Disorders, Appetite regulation, Eating Regulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Appetite Awareness
Arm Type
Experimental
Arm Description
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
Arm Title
Nutrition Education
Arm Type
Active Comparator
Arm Description
Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.
Arm Title
No Treatment Control
Arm Type
No Intervention
Arm Description
No intervention, assessment only
Intervention Type
Behavioral
Intervention Name(s)
Appetite Awareness
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Nutrition Education
Intervention Description
Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.
Primary Outcome Measure Information:
Title
Change in Body Weight measured in pounds
Time Frame
Baseline, 6 weeks, 4 months
Title
Change in Appetite Awareness as assessed by the Interoceptive Awareness Questionnaire (appetite subscale)
Time Frame
Baseline, 6 weeks, 4 months
Secondary Outcome Measure Information:
Title
Change in Body Image as assessed by the Satisfaction and Dissatisfaction with Body Parts Scale
Time Frame
6 weeks, 4 months
Title
Change in Weight Management self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire
Time Frame
6 weeks, 4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Incoming University of Minnesota Duluth freshmen women residing in on campus dormitories Exclusion Criteria: Males, non-dormitory residing, non-freshmen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara LaCaille, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55812
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Brief Appetite Awareness Intervention for Eating and Weight Regulation Among College Freshmen

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