Internal Cues Versus External Cues for Eating and Activity

NCT ID: NCT04025099

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-08
• Study Completion Date: 2020-04-15

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.

Conditions

Eating Behavior; Body Image; Diet Habit; Dietary Habits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Internal Cues

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)

Group Type: EXPERIMENTAL

Internal Cues

Intervention Type: OTHER

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 Cues

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)

Group Type: ACTIVE_COMPARATOR

External Cues

Intervention Type: OTHER

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.

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:

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internal Cues

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.

Intervention Type: OTHER

External Cues

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.

Intervention Type: OTHER

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

• They have a severe medical food allergy.
• They are pregnant - this program is not geared towards someone who is pregnant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Carly R Pacanowski

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carly Pacanowski, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

University of Delaware

Newark, Delaware, United States

Countries

United States

Other Identifiers

1408101

Identifier Type: -

Identifier Source: org_study_id