- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04025099
Internal Cues Versus External Cues for Eating and Activity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed study, Internal versus External Cues for Eating and Activity, will collect data on within-person changes in psychological (e.g. attunement with bodily signals, eating and activity behaviors) and physiological (e.g., body mass index, heart rate, saliva) markers of risk for both eating disorders and obesity in female University of Delaware students. Outcomes will be assessed at baseline, mid-treatment, end-of-treatment, and one-year follow-up. 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. The Internal Cues group will attend one intuitive eating session and take three body-positive yoga sessions weekly for ten weeks. The External Cues group will attend one healthy weight class and three cardiovascular-based exercise sessions each week for ten weeks. The Assessment Only no-treatment control group will only attend assessments. The curriculum for the intuitive eating classes (previously piloted and revised accordingly) and healthy weight classes (modeled off of classes offered at universities and government-available recommendations and educational documents) will be taught by two Registered Dietitians who are Certified Intuitive Eating Counselors. The yoga classes will be taught by a Registered Yoga Instructor trained in Body Positive Yoga and in a curriculum specifically designed for UD students (funded by Dean Matt). 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 External Cues group will receive an identical dinner during the class period but they will learn how to properly portion their meals to meet their caloric needs, in line with traditional education about weight control. Finally, 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.
Additionally, the interventionists for both the Internal Cues and External Cues sessions will be video recorded to allow content to be tested in a lab study following the intervention. The research team worked with IT at STAR campus to position equipment so that the video only captures the interventionists (session leaders). Participants will not be recorded. If any participant audio is captured, content containing participants' voices will be deleted from the file. The purpose of recording is to modify the curriculum for future interventions and programs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Delaware
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Newark, Delaware, United States, 19711
- University of Delaware
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- They do not meet the inclusion criteria.
- They have a severe medical food allergy.
- They are pregnant - this program is not geared towards someone who is pregnant.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Internal Cues
Over 10 weeks, participants will be asked to participate in the following:
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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. |
Active Comparator: External Cues
Over the next 10 weeks, participants will be asked to participate in the following:
|
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. |
No Intervention: Assessment Only
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intuitive Eating
Time Frame: Baseline - week 1
|
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
Time Frame: Midpoint - week 5
|
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
Time Frame: End of study - week 10
|
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
Time Frame: Follow-up - 1 year post study completion
|
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
Time Frame: Baseline - week 1
|
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
Time Frame: Midpoint - week 5
|
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
Time Frame: End of study - week 10
|
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
Time Frame: Follow-up - 1 year post study completion
|
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
Time Frame: Baseline - week 1
|
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
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Dietary Restraint
Time Frame: Midpoint - week 5
|
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
Time Frame: End of study - week 10
|
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
Time Frame: Follow-up - 1 year post study completion
|
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
Time Frame: Baseline - week 1
|
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
Time Frame: Midpoint - week 5
|
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
Time Frame: End of study - week 10
|
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
Time Frame: Follow-up - 1 year post study completion
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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
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Body Appreciation
Time Frame: Baseline - week 1
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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
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Body Appreciation
Time Frame: Midpoint - week 5
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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
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Body Appreciation
Time Frame: End of study - week 10
|
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
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Body Appreciation
Time Frame: Follow-up - 1 year post study completion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fruit Consumption
Time Frame: Baseline - week 1
|
Using select modified questions from YRBS and Project EAT One question Measures fruit consumption in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many times did you eat fruit? (Do not count fruit juice). Score answers range from 1 to 7, with 1 being "I did not eat fruit during a typical week" and 7 being "4 or more times per day during a typical week" Higher scores indicate greater consumption of fruit in a typical week over the past 5 weeks |
Baseline - week 1
|
Fruit Consumption
Time Frame: Midpoint - week 5
|
Using select modified questions from YRBS and Project EAT One question Measures fruit consumption in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many times did you eat fruit? (Do not count fruit juice). Score answers range from 1 to 7, with 1 being "I did not eat fruit during a typical week" and 7 being "4 or more times per day during a typical week" Higher scores indicate greater consumption of fruit in a typical week over the past 5 weeks |
Midpoint - week 5
|
Fruit Consumption
Time Frame: End of study - week 10
|
Using select modified questions from YRBS and Project EAT One question Measures fruit consumption in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many times did you eat fruit? (Do not count fruit juice). Score answers range from 1 to 7, with 1 being "I did not eat fruit during a typical week" and 7 being "4 or more times per day during a typical week" Higher scores indicate greater consumption of fruit in a typical week over the past 5 weeks |
End of study - week 10
|
Fruit Consumption
Time Frame: Follow-up - 1 year post study completion
|
Using select modified questions from YRBS and Project EAT One question Measures fruit consumption in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many times did you eat fruit? (Do not count fruit juice). Score answers range from 1 to 7, with 1 being "I did not eat fruit during a typical week" and 7 being "4 or more times per day during a typical week" Higher scores indicate greater consumption of fruit in a typical week over the past 5 weeks |
Follow-up - 1 year post study completion
|
Vegetable Consumption
Time Frame: Baseline - week 1
|
Using select modified questions from YRBS and Project EAT One question Measures vegetable consumption in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many times did you eat vegetables? (Do not count green salad, potatoes, or carrots). Score answers range from 1 to 7, with 1 being "I did not eat vegetables during a typical week" and 7 being "4 or more times per day during a typical week" Higher scores indicate greater consumption of vegetables in a typical week over the past 5 weeks |
Baseline - week 1
|
Vegetable Consumption
Time Frame: Midpoint - week 5
|
Using select modified questions from YRBS and Project EAT One question Measures vegetable consumption in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many times did you eat vegetables? (Do not count green salad, potatoes, or carrots). Score answers range from 1 to 7, with 1 being "I did not eat vegetables during a typical week" and 7 being "4 or more times per day during a typical week" Higher scores indicate greater consumption of vegetables in a typical week over the past 5 weeks |
Midpoint - week 5
|
Vegetable Consumption
Time Frame: End of study - week 10
|
Using select modified questions from YRBS and Project EAT One question Measures vegetable consumption in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many times did you eat vegetables? (Do not count green salad, potatoes, or carrots). Score answers range from 1 to 7, with 1 being "I did not eat vegetables during a typical week" and 7 being "4 or more times per day during a typical week" Higher scores indicate greater consumption of vegetables in a typical week over the past 5 weeks |
End of study - week 10
|
Vegetable Consumption
Time Frame: Follow-up - 1 year post study completion
|
Using select modified questions from YRBS and Project EAT One question Measures vegetable consumption in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many times did you eat vegetables? (Do not count green salad, potatoes, or carrots). Score answers range from 1 to 7, with 1 being "I did not eat vegetables during a typical week" and 7 being "4 or more times per day during a typical week" Higher scores indicate greater consumption of vegetables in a typical week over the past 5 weeks |
Follow-up - 1 year post study completion
|
Participation in Yoga
Time Frame: Baseline - week 1
|
Using select modified questions from YRBS and Project EAT One question Measures participation in yoga in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many hours did you practice yoga?". Score answers range from 1 to 7, with 1 being "0 hours during a typical week" and 7 being "10+ hours during a typical week" Higher scores indicate greater frequency spent practicing yoga in a typical week over the past 5 weeks |
Baseline - week 1
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Participation in Yoga
Time Frame: Midpoint - week 5
|
Using select modified questions from YRBS and Project EAT One question Measures participation in yoga in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many hours did you practice yoga?". Score answers range from 1 to 7, with 1 being "0 hours during a typical week" and 7 being "10+ hours during a typical week" Higher scores indicate greater frequency spent practicing yoga in a typical week over the past 5 weeks |
Midpoint - week 5
|
Participation in Yoga
Time Frame: End of study - week 10
|
Using select modified questions from YRBS and Project EAT One question Measures participation in yoga in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many hours did you practice yoga?". Score answers range from 1 to 7, with 1 being "0 hours during a typical week" and 7 being "10+ hours during a typical week" Higher scores indicate greater frequency spent practicing yoga in a typical week over the past 5 weeks |
End of study - week 10
|
Participation in Yoga
Time Frame: Follow-up - 1 year post study completion
|
Using select modified questions from YRBS and Project EAT One question Measures participation in yoga in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many hours did you practice yoga?". Score answers range from 1 to 7, with 1 being "0 hours during a typical week" and 7 being "10+ hours during a typical week" Higher scores indicate greater frequency spent practicing yoga in a typical week over the past 5 weeks |
Follow-up - 1 year post study completion
|
Participation in Physical Activity
Time Frame: Baseline - week 1
|
Using select modified questions from YRBS and Project EAT One question Measures participation in cardiovascular exercise in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many hours did you engage in cardio exercise? (Add up all the time you spent in any kind of physical activity that increased your heart rate and made you breathe hard some of the time)". Score answers range from 1 to 7, with 1 being "0 hours during a typical week" and 7 being "10+ hours during a typical week" Higher scores indicate greater frequency spent engaging in cardiovascular exercise in a typical week over the past 5 weeks |
Baseline - week 1
|
Participation in Physical Activity
Time Frame: Midpoint - week 5
|
Using select modified questions from YRBS and Project EAT One question Measures participation in cardiovascular exercise in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many hours did you engage in cardio exercise? (Add up all the time you spent in any kind of physical activity that increased your heart rate and made you breathe hard some of the time)". Score answers range from 1 to 7, with 1 being "0 hours during a typical week" and 7 being "10+ hours during a typical week" Higher scores indicate greater frequency spent engaging in cardiovascular exercise in a typical week over the past 5 weeks |
Midpoint - week 5
|
Participation in Physical Activity
Time Frame: End of study - week 10
|
Using select modified questions from YRBS and Project EAT One question Measures participation in cardiovascular exercise in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many hours did you engage in cardio exercise? (Add up all the time you spent in any kind of physical activity that increased your heart rate and made you breathe hard some of the time)". Score answers range from 1 to 7, with 1 being "0 hours during a typical week" and 7 being "10+ hours during a typical week" Higher scores indicate greater frequency spent engaging in cardiovascular exercise in a typical week over the past 5 weeks |
End of study - week 10
|
Participation in Physical Activity
Time Frame: Follow-up - 1 year post study completion
|
Using select modified questions from YRBS and Project EAT One question Measures participation in cardiovascular exercise in a typical week over the past 5 weeks Question asks: "Thinking about the past 5 weeks, in a typical week, how many hours did you engage in cardio exercise? (Add up all the time you spent in any kind of physical activity that increased your heart rate and made you breathe hard some of the time)". Score answers range from 1 to 7, with 1 being "0 hours during a typical week" and 7 being "10+ hours during a typical week" Higher scores indicate greater frequency spent engaging in cardiovascular exercise in a typical week over the past 5 weeks |
Follow-up - 1 year post study completion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carly Pacanowski, PhD, University of Delaware
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1408101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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