Internal Cues Versus External Cues for Eating and Activity
1 other identifier
interventional
32
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
July 18, 2019
CompletedStudy Start
First participant enrolled
September 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2020
CompletedApril 27, 2021
April 1, 2021
7 months
July 12, 2019
April 26, 2021
Conditions
Keywords
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
EXPERIMENTALOver 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)
External Cues
ACTIVE COMPARATOROver 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)
Assessment Only
NO INTERVENTIONOver 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.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carly Pacanowski, PhD
University of Delaware
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- 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