Eating BehaviorNCT04025099
Internal Cues Versus External Cues for Eating and Activity
A study testing Internal Cues and External Cues in people with Eating Behavior and Body Image, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior, Body Image, Diet Habit
- What is being tested?
- Internal Cues and External Cues
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2019to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Eating Behavior, Body Image, Diet Habit, Dietary Habits
- Being tested
- Internal Cues, External Cues
- Keywords
- intuitive eating, body positive yoga, weight management, cardiovascular fitness, interoceptive awareness, embodiment, internal cues, external cues
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal CuesOther
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.
External CuesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Follow-up - 1 year post study completion
Secondary outcomes (16)
Fruit Consumption
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
Measured: Baseline - week 1
Fruit Consumption
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
Measured: Midpoint - week 5
Fruit Consumption
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
Measured: End of study - week 10
Fruit Consumption
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
Measured: Follow-up - 1 year post study completion
Vegetable Consumption
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
Measured: Baseline - week 1
Vegetable Consumption
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
Measured: Midpoint - week 5
Vegetable Consumption
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
Measured: End of study - week 10
Vegetable Consumption
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
Measured: Follow-up - 1 year post study completion
Participation in Yoga
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
Measured: Baseline - week 1
Participation in Yoga
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
Measured: Midpoint - week 5
Participation in Yoga
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
Measured: End of study - week 10
Participation in Yoga
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
Measured: Follow-up - 1 year post study completion
Participation in Physical Activity
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
Measured: Baseline - week 1
Participation in Physical Activity
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
Measured: Midpoint - week 5
Participation in Physical Activity
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
Measured: End of study - week 10
Participation in Physical Activity
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
Measured: Follow-up - 1 year post study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start8 Sep 2019
- Primary completion15 Apr 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly R Pacanowski, University of Delaware
- Investigators
- Carly Pacanowski, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025099
- Sponsor's protocol ID
- 1408101
- Status last verified
- Apr 2021
- First submitted
- 12 Jul 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Cues Versus External Cues for Eating and Activity
- ClinicalTrials.gov ID
- NCT04025099
- Acronym / sponsor ID
- 1408101
- Conditions
- Eating Behavior, Body Image, Diet Habit, Dietary Habits
- Keywords
- intuitive eating, body positive yoga, weight management, cardiovascular fitness, interoceptive awareness, embodiment, internal cues, external cues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Internal Cues | Experimental | Other: Internal CuesOver 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 comparator | Other: External CuesOver 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 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) |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal CuesThe 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. | Other | Internal Cues |
| External CuesThe 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. | Other | External Cues |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Embodiment
Time frame: Follow-up - 1 year post study completion
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
Body Appreciation
Time frame: Baseline - week 1
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
Body Appreciation
Time frame: Midpoint - week 5
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
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
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
16 secondary outcomes
Fruit Consumption
Time frame: Baseline - week 1
Fruit Consumption
Time frame: Midpoint - week 5
Fruit Consumption
Time frame: End of study - week 10
Fruit Consumption
Time frame: Follow-up - 1 year post study completion
Vegetable Consumption
Time frame: Baseline - week 1
Vegetable Consumption
Time frame: Midpoint - week 5
Vegetable Consumption
Time frame: End of study - week 10
Vegetable Consumption
Time frame: Follow-up - 1 year post study completion
Participation in Yoga
Time frame: Baseline - week 1
Participation in Yoga
Time frame: Midpoint - week 5
Participation in Yoga
Time frame: End of study - week 10
Participation in Yoga
Time frame: Follow-up - 1 year post study completion
Participation in Physical Activity
Time frame: Baseline - week 1
Participation in Physical Activity
Time frame: Midpoint - week 5
Participation in Physical Activity
Time frame: End of study - week 10
Participation in Physical Activity
Time frame: Follow-up - 1 year post study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carly Pacanowski, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Cues and External Cues in people with Eating Behavior and Body Image, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intuitive Eating (time frame: Baseline - week 1). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.