Eating Behavior Clinical Trial
Official title:
Internal Cues Versus External Cues for Eating and Activity
Verified date | April 2021 |
Source | University of Delaware |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | April 15, 2020 |
Est. primary completion date | April 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 26 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Delaware | Newark | Delaware |
Lead Sponsor | Collaborator |
---|---|
University of Delaware |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 |
Baseline - week 1 | |
Secondary | 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 |
Midpoint - week 5 | |
Secondary | 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 |
End of study - week 10 | |
Secondary | 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 |
Follow-up - 1 year post study completion | |
Secondary | 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 |
Baseline - week 1 | |
Secondary | 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 |
Midpoint - week 5 | |
Secondary | 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 |
End of study - week 10 | |
Secondary | 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 |
Follow-up - 1 year post study completion | |
Secondary | 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 |
Baseline - week 1 | |
Secondary | 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 |
Midpoint - week 5 | |
Secondary | 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 |
End of study - week 10 | |
Secondary | 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 |
Follow-up - 1 year post study completion | |
Secondary | 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 |
Baseline - week 1 | |
Secondary | 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 |
Midpoint - week 5 | |
Secondary | 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 |
End of study - week 10 | |
Secondary | 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 |
Follow-up - 1 year post study completion |
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