Clinical trial NCT04025099: Internal Cues Versus External Cues for Eating and Activity
Official title: Internal Cues Versus External Cues for Eating and Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intuitive Eating
timeFrame: Baseline - week 1
measure: Intuitive Eating
timeFrame: Midpoint - week 5
measure: Intuitive Eating
timeFrame: End of study - week 10
measure: Intuitive Eating
timeFrame: Follow-up - 1 year post study completion
measure: Interoceptive Awareness
timeFrame: Baseline - week 1
measure: Interoceptive Awareness
timeFrame: Midpoint - week 5
measure: Interoceptive Awareness
timeFrame: End of study - week 10
measure: Interoceptive Awareness
timeFrame: Follow-up - 1 year post study completion
measure: Dietary Restraint
timeFrame: Baseline - week 1
measure: Dietary Restraint
timeFrame: Midpoint - week 5
measure: Dietary Restraint
timeFrame: End of study - week 10
measure: Dietary Restraint
timeFrame: Follow-up - 1 year post study completion
measure: Embodiment
timeFrame: Baseline - week 1
measure: Embodiment
timeFrame: Midpoint - week 5
measure: Embodiment
timeFrame: End of study - week 10
measure: Embodiment
timeFrame: Follow-up - 1 year post study completion
measure: Body Appreciation
timeFrame: Baseline - week 1
measure: Body Appreciation
timeFrame: Midpoint - week 5
measure: Body Appreciation
timeFrame: End of study - week 10
measure: Body Appreciation
timeFrame: Follow-up - 1 year post study completion
Secondary outcomes:
measure: Fruit Consumption
timeFrame: Baseline - week 1
measure: Fruit Consumption
timeFrame: Midpoint - week 5
measure: Fruit Consumption
timeFrame: End of study - week 10
measure: Fruit Consumption
timeFrame: Follow-up - 1 year post study completion
measure: Vegetable Consumption
timeFrame: Baseline - week 1
measure: Vegetable Consumption
timeFrame: Midpoint - week 5
measure: Vegetable Consumption
timeFrame: End of study - week 10
measure: Vegetable Consumption
timeFrame: Follow-up - 1 year post study completion
measure: Participation in Yoga
timeFrame: Baseline - week 1
measure: Participation in Yoga
timeFrame: Midpoint - week 5
measure: Participation in Yoga
timeFrame: End of study - week 10
measure: Participation in Yoga
timeFrame: Follow-up - 1 year post study completion
measure: Participation in Physical Activity
timeFrame: Baseline - week 1
measure: Participation in Physical Activity
timeFrame: Midpoint - week 5
measure: Participation in Physical Activity
timeFrame: End of study - week 10
measure: Participation in Physical Activity
timeFrame: Follow-up - 1 year post study completion
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Carly Pacanowski, PhD
role: PRINCIPAL_INVESTIGATOR
References: