NCT02496637

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

July 6, 2015

Last Update Submit

October 9, 2018

Conditions

Keywords

ObesityEating DisordersAppetite regulationEating Regulation

Outcome Measures

Primary Outcomes (2)

  • Change in Body Weight measured in pounds

    Baseline, 6 weeks, 4 months

  • Change in Appetite Awareness as assessed by the Interoceptive Awareness Questionnaire (appetite subscale)

    Baseline, 6 weeks, 4 months

Secondary Outcomes (2)

  • Change in Body Image as assessed by the Satisfaction and Dissatisfaction with Body Parts Scale

    6 weeks, 4 months

  • Change in Weight Management self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire

    6 weeks, 4 months

Study Arms (3)

Appetite Awareness

EXPERIMENTAL

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

Behavioral: Appetite Awareness

Nutrition Education

ACTIVE COMPARATOR

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

Behavioral: Nutrition Education

No Treatment Control

NO INTERVENTION

No intervention, assessment only

Interventions

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

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

Nutrition Education

Eligibility Criteria

Age18 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Duluth

Duluth, Minnesota, 55812, United States

Location

MeSH Terms

Conditions

ObesityFeeding and Eating Disorders

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Lara LaCaille, PhD

    University of Minnesota

    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
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 14, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations