NCT03947008

Brief Summary

College-aged women are at risk for eating disorders and disordered eating, which present serious health concerns. Two potent risk factors for eating disorders, body dissatisfaction and dietary restraint, are common among female college students. Intuitive eating is a strategy in which instead of listening to the predominant 'diet culture' and focusing on things like calories and energy balance, individuals practice listening to their internal physiological signals to decide when and what to eat and when to stop. Based on current research, intuitive eating has been shown to foster body satisfaction and healthy eating attitudes among women. The proposed pilot study will evaluate the feasibility and acceptability of an intuitive eating program for University of Delaware college women. In addition, this study will test the hypothesis that the intuitive eating program will reduce cognitive factors of body dissatisfaction and dietary restraint in females compared to a waitlisted group. Additionally, the investigators expect this reduction in dietary restraint to be associated with less disordered eating behavior. Exploratory aims include measuring engagement in disordered eating behaviors and changes in weight over the study period. This preliminary data will be used to estimate effect sizes for larger future trials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

January 9, 2019

Last Update Submit

November 19, 2019

Conditions

Keywords

intuitive eatingdietary restraint

Outcome Measures

Primary Outcomes (4)

  • Dietary Restraint

    Measured via a survey that uses questions from the following validated questionnaires: ●Three-Factor Eating Questionnaire-18 * Measures dietary restraint * Means are computed for three subscales and are transformed to a 0-100 scale score * Higher scores indicate greater cognitive restraint, uncontrolled, emotional eating

    5 weeks

  • Body Appreciation: survey

    Body appreciation will be measured via a survey. This survey uses questions from the validated Body Appreciation Scale-2. There are 10 questions rated from 1 "never to 5 "always". The 10 scores from each question are totaled and averaged. Higher scores reflect greater body appreciation.

    5 weeks

  • Intuitive Eating

    Measured using the following validated survey: ●Intuitive Eating Scale - 2 * Measures tendency to follow physical hunger and fullness cues * \*Total\*score range = 5-115 * Higher scores indicate greater levels of intuitive eating or its dimensions

    5 weeks

  • Interoceptive Awareness

    Measured using the Multi-Dimensional Assessment of Interoceptive Awareness -2

    5 weeks

Secondary Outcomes (2)

  • Weight

    5 weeks

  • Height

    5 weeks

Study Arms (2)

First Intuitive Eating Group (IE1)

EXPERIMENTAL

IE1 will be the first group to participate in an intuitive eating program and will be required to attend five intuitive eating classes. The intuitive eating classes will be 60-minutes each week for 5 weeks. An initial assessment will be conducted during the first thirty minutes of the first intuitive eating class. A final assessment will be conducted during the last 30 minutes of the last intuitive eating class. This group will have an additional final assessment on the last day of the IE2's intuitive eating course. During the assessments, they will complete a questionnaire that will ask them about their body satisfaction and eating attitudes, and have their height and weight measured.

Other: Intuitive Eating Program

Second Intuitive Eating Group (IE2)

EXPERIMENTAL

IE2 will be the second group to will participate in an intuitive eating program and will be required to attend 5 intuitive eating classes. The classes will be 60-minutes each week for 5 weeks. An initial assessment will be conducted on the same day as IE1 but they will take the 5 week course once the first group completes the class. This group will have an additional initial assessment on the day they begin their curriculum. The initial assessment will occur during the first thirty minutes of the first intuitive eating class. A final assessment will be conducted during the last 30 minutes of the last intuitive eating class. During assessments, they will complete a questionnaire that will ask about body satisfaction and eating attitudes, and have their height and weight measured.

Other: Intuitive Eating Program

Interventions

A 5-week Intuitive Eating Curriculum created by a Registered Dietitian, Kaylee Frazier, will be used. The creator of this curriculum was contacted for permission and the curriculum was modified for use with college women. The goal of the program is to challenge and eventually shift participant's mindset from the traditional diet culture towards a way of eating that is driven by their unique bodily needs. Content will focus on training participant to listen to their internal body cues for hunger opposed to restricting or eliminating foods. A list of intuitive eating principles and ways to incorporate them into daily routines will be provided to the participants throughout the sessions, coupled with homework assignments, journaling, and exercises to be completed before subsequent sessions.

First Intuitive Eating Group (IE1)Second Intuitive Eating Group (IE2)

Eligibility Criteria

Age18 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The participant is between the age of 18-26;
  • University of Delaware student;
  • Willing and able to commit to the 5-week study at specified time;
  • Has a history of body dissatisfaction as indicated by high survey scores on body satisfaction and high scores on dietary restraint; and
  • Are not currently being treated for an eating disorder.

You may not qualify if:

  • Females who are currently diagnosed with and/or seeking treatment for an eating disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19711, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Carly Pacanowski, PhD

    Faculty Support

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The proposed pilot study will evaluate the feasibility and acceptability of an intuitive eating program for University of Delaware college women. A randomized controlled design will be used to study the effects of an intuitive eating intervention on body dissatisfaction and dietary restraint in young adult women, thereby reducing risk of eating disorders. There will be 2 arms of this study. The First Intuitive Eating Group (IE1) will act as the intervention group and receive the intervention first. The Second Intuitive Eating Group (IE2) will act as a waitlist group and receive the intervention the week immediately following the end of IE1's course.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Faculty Support

Study Record Dates

First Submitted

January 9, 2019

First Posted

May 13, 2019

Study Start

February 28, 2019

Primary Completion

May 9, 2019

Study Completion

May 9, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations