NCT04025099

Brief Summary

The majority of female undergraduate students experience disordered eating and/or weight gain, increasing the risk for two serious public health problems, eating disorders and obesity. Traditional nutrition education about weight control delivered during college has not been effective and may even exacerbate these problems. Thus, the investigators propose that instead of focusing on external information as taught by nutrition education (e.g. 'calories in, calories out', quantification and cognitive processing of nutrition information), at-risk females be trained to become more attuned to their internal hunger and fullness signaling to set them on a trajectory for decreased chronic disease risk as they age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 8, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

July 12, 2019

Last Update Submit

April 26, 2021

Conditions

Keywords

intuitive eatingbody positive yogaweight managementcardiovascular fitnessinteroceptive awarenessembodimentinternal cuesexternal cues

Outcome Measures

Primary Outcomes (20)

  • Intuitive Eating

    Using the 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

    Baseline - week 1

  • Intuitive Eating

    Using the 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

    Midpoint - week 5

  • Intuitive Eating

    Using the 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

    End of study - week 10

  • Intuitive Eating

    Using the 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

    Follow-up - 1 year post study completion

  • Interoceptive Awareness

    Using the Multi-Dimensional Assessment of Interoceptive Awareness - 2 Measures the multiple levels of individual interoception \*Total\*score range = 0-185 Higher total scores and sub scale scores indicate higher levels of positive awareness

    Baseline - week 1

  • Interoceptive Awareness

    Using the Multi-Dimensional Assessment of Interoceptive Awareness - 2 Measures the multiple levels of individual interoception \*Total\*score range = 0-185 Higher total scores and sub scale scores indicate higher levels of positive awareness

    Midpoint - week 5

  • Interoceptive Awareness

    Using the Multi-Dimensional Assessment of Interoceptive Awareness - 2 Measures the multiple levels of individual interoception \*Total\*score range = 0-185 Higher total scores and sub scale scores indicate higher levels of positive awareness

    End of study - week 10

  • Interoceptive Awareness

    Using the Multi-Dimensional Assessment of Interoceptive Awareness - 2 Measures the multiple levels of individual interoception \*Total\*score range = 0-185 Higher total scores and sub scale scores indicate higher levels of positive awareness

    Follow-up - 1 year post study completion

  • Dietary Restraint

    Using the 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

    Baseline - week 1

  • Dietary Restraint

    Using the 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

    Midpoint - week 5

  • Dietary Restraint

    Using the 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

    End of study - week 10

  • Dietary Restraint

    Using the 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

    Follow-up - 1 year post study completion

  • Embodiment

    Using the Experience of Embodiment Scale - Body Connection and Comfort Subscale Measures one of the five dimensions of embodiment: body connection and comfort Subscale score range = 12-36 Higher sub scale scores indicate higher levels of embodiment in terms of connection and comfort to one's body

    Baseline - week 1

  • Embodiment

    Using the Experience of Embodiment Scale - Body Connection and Comfort Subscale Measures one of the five dimensions of embodiment: body connection and comfort Subscale score range = 12-36 Higher sub scale scores indicate higher levels of embodiment in terms of connection and comfort to one's body

    Midpoint - week 5

  • Embodiment

    Using the Experience of Embodiment Scale - Body Connection and Comfort Subscale Measures one of the five dimensions of embodiment: body connection and comfort Subscale score range = 12-36 Higher sub scale scores indicate higher levels of embodiment in terms of connection and comfort to one's body

    End of study - week 10

  • Embodiment

    Using the Experience of Embodiment Scale - Body Connection and Comfort Subscale Measures one of the five dimensions of embodiment: body connection and comfort Subscale score range = 12-36 Higher sub scale scores indicate higher levels of embodiment in terms of connection and comfort to one's body

    Follow-up - 1 year post study completion

  • Body Appreciation

    Using the Body Appreciation Scale - 2 Measures one's acceptance of, favorable opinions toward, and respect for their body Score answers are totaled and divided by 10 for an average score. \*total\* average scores can range from = 1-5 Higher scores indicate higher levels of body appreciation

    Baseline - week 1

  • Body Appreciation

    Using the Body Appreciation Scale - 2 Measures one's acceptance of, favorable opinions toward, and respect for their body Score answers are totaled and divided by 10 for an average score. \*total\* average scores can range from = 1-5 Higher scores indicate higher levels of body appreciation

    Midpoint - week 5

  • Body Appreciation

    Using the Body Appreciation Scale - 2 Measures one's acceptance of, favorable opinions toward, and respect for their body Score answers are totaled and divided by 10 for an average score. \*total\* average scores can range from = 1-5 Higher scores indicate higher levels of body appreciation

    End of study - week 10

  • Body Appreciation

    Using the Body Appreciation Scale - 2 Measures one's acceptance of, favorable opinions toward, and respect for their body Score answers are totaled and divided by 10 for an average score. \*total\* average scores can range from = 1-5 Higher scores indicate higher levels of body appreciation

    Follow-up - 1 year post study completion

Secondary Outcomes (16)

  • Fruit Consumption

    Baseline - week 1

  • Fruit Consumption

    Midpoint - week 5

  • Fruit Consumption

    End of study - week 10

  • Fruit Consumption

    Follow-up - 1 year post study completion

  • Vegetable Consumption

    Baseline - week 1

  • +11 more secondary outcomes

Study Arms (3)

Internal Cues

EXPERIMENTAL

Over 10 weeks, participants will be asked to participate in the following: 1. Classes (held in STAR Tower 419/420 IPE Space and Conference Room 413) * One \~60-minute Intuitive Eating class per week (total = 10 classes); * Two \~60-minute yoga classes per week (total = 20 classes); * Repeat one of the \~60-minute yoga classes each week on the participants' own, in a space participants feel comfortable, using a video recording (total = 10 classes). 2. Assessments (held in STAR tower) * Three \~60-minute assessments\* which will include: 1. Height \& weight measurements (taken privately) 2. A questionnaire that asks about participants' relationship with their body and eating and activity behaviors 3. Collection of participants' heart rate overnight (on their own) 4. Collection of participants' saliva three times in one day (on their own)

Other: Internal Cues

External Cues

ACTIVE COMPARATOR

Over the next 10 weeks, participants will be asked to participate in the following: 1. Classes (held in STAR Tower 419/420 IPE Space) * One \~60-minute Healthy Eating class per week (total = 10 classes); * Participants will be provided with a UD group fitness membership. Using this membership, participants will be asked to attend at least 2 cardio fitness classes per week and do an additional 30 minutes of heart-raising activity on participants' own (total = 3 exercise sessions/week). 2. Assessments (held in STAR tower) * Three \~60-minute assessments\* which will include: 1. Height \& weight measurements (taken privately) 2. A questionnaire that asks about participants' relationship with their body and eating and activity behaviors 3. Collection of participants' heart rate overnight (on their own) 4. Collection of participants' saliva three times in one day (on their own)

Other: External Cues

Assessment Only

NO INTERVENTION

Over the next 10 weeks, participants will be asked to participate in the following: a. Assessments (held in STAR tower) •Three \~60-minute assessments\* which will include: 1. Height \& weight measurements (taken privately) 2. A questionnaire that asks about participants' relationship with their body and eating and activity behaviors 3. Collection of participants' heart rate overnight (on their own) 4. Collection of participants' saliva three times in one day (on their own)

Interventions

The intuitive eating curriculum that was pilot tested and adapted has been modified for use for the Internal Cues group with college-aged females for delivery over a 10-week time period. The classes will be delivered by two Registered Dietitians and Certified Intuitive Eating Counselors from the University of Delaware, Julia Katcher and Maryann Eastep. During the Internal Cues group's intuitive eating classes, participants will, as a group, eat dinner that is prepared by ServSafe certified undergraduate dietetics students in the test kitchen in the STAR Tower. This dinner will allow the participants to experientially learn the intuitive eating principles taught in class. The yoga classes will be adapted to all levels of experience, mobility, and body size. Specific breathing techniques and body positive language will be incorporated into a body-positive yoga training done by Ms. Lisa Jones, RYT.

Internal Cues

The 10-week traditional healthy weight program for the External Cues group was created by a Graduate Assistant based on MyPlate principles. The External Cues classes will be delivered by two Registered Dietitians from the University of Delaware, Julia Katcher and Maryann Eastep. During the External Cues group's healthy eating classes, participants will, as a group, eat dinner that is prepared by ServSafe certified undergraduate dietetics students in the test kitchen in the STAR Tower. This dinner will allow the participants to experientially learn how to properly portion their meals to meet their caloric needs, in line with traditional education about weight control. Students randomized to the External Cues group will receive a UD fitness pass and will be able to choose from select cardio-based fitness classes in order to meet public health recommendations for physical activity.

External Cues

Eligibility Criteria

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

You may qualify if:

  • Female
  • Between the ages of 18 and 26
  • Freshman, Sophomore, or Junior University of Delaware student
  • Willing and able to commit to the 10-week study at the specified times and a follow up visit 1-year after the completion of the study
  • Have concerns about body shape, weight, and/or eating
  • Are not currently being treated for an eating disorder

You may not qualify if:

  • They have a severe medical food allergy.
  • They are pregnant - this program is not geared towards someone who is pregnant.

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

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This three-armed randomized, controlled trial will assess the effects of a novel internal cues intervention (treatment group; intuitive eating and body positive yoga) compared to an active control group consisting of traditional healthy weight sessions, following standardized government recommendations for eating and activity, and a no-treatment control group completing assessments only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 18, 2019

Study Start

September 8, 2019

Primary Completion

April 15, 2020

Study Completion

April 15, 2020

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations