Eating Behavior Clinical Trial
Official title:
The Effects of Intuitive Eating on Body Appreciation and Dietary Restraint in College Females
College-aged women are at risk for eating disorders and disordered eating, which present
serious health concerns. Two potent risk factors for eating disorders, body dissatisfaction
and dietary restraint, are common among female college students.
Intuitive eating is a strategy in which instead of listening to the predominant 'diet
culture' and focusing on things like calories and energy balance, individuals practice
listening to their internal physiological signals to decide when and what to eat and when to
stop. Based on current research, intuitive eating has been shown to foster body satisfaction
and healthy eating attitudes among women.
The proposed pilot study will evaluate the feasibility and acceptability of an intuitive
eating program for University of Delaware college women. In addition, this study will test
the hypothesis that the intuitive eating program will reduce cognitive factors of body
dissatisfaction and dietary restraint in females compared to a waitlisted group.
Additionally, the investigators expect this reduction in dietary restraint to be associated
with less disordered eating behavior. Exploratory aims include measuring engagement in
disordered eating behaviors and changes in weight over the study period. This preliminary
data will be used to estimate effect sizes for larger future trials.
The overall goal of the program is to challenge and eventually shift participant's mindset
from the traditional diet culture towards a way of eating that is driven by their unique
bodily needs. Thus, content will focus on training participant to listen to their internal
body cues for hunger opposed to restricting or eliminating foods. A list of intuitive eating
principles and ways to incorporate them into daily routines will be provided to the
participants throughout the sessions, coupled with homework assignments, journaling, and
exercises to be completed before subsequent sessions.
This program will be delivered by two Registered Dietitians from the University of Delaware,
Julia Katcher and Maryann Eastep. Both will have received training from
https://www.helmpublishing.com/intuitive-eating-certificate-of-training-1891 and will have
become Certified Intuitive Eating Counselors by the start of Spring 2019.
After being screened for eligibility and meeting eligibility criteria, the individual will be
emailed by the PI, who will invite the individual to participate in the study and enclose an
invitation for their first intuitive eating class. This email will also include a copy of the
consent form for them to review and decide if they want to commit to the study. If the
individual is still interested in participating they will email the PI again to be placed on
the participant list. After 24 individuals, who have met screening criteria, have indicated
desire to participate, they will be randomized to one of two conditions: (1) First Intuitive
Eating Group (IE1) offered once per week for 5 weeks; or (2) Second Intuitive Eating Group
(IE2), who will receive the same intuitive eating course after the first group has concluded.
Baseline assessments will be conducted on all participants, both IE1 and IE2, on the same
day, at the beginning of the first intuitive eating class for IE1 group. These assessments
will be conducted by the project staff identified above. The assessment should not take
longer than 30 minutes. When the participants arrive, they will first have the opportunity to
discuss the study with the PI, ask any questions or address any concerns they might have and
if interested, sign the consent form. Consent forms will be provided, prior to the initial
assessment and the intuitive eating class beginning, to be reviewed and signed in the
presence of the PI.
After signing the consent form, then they will fill out the questionnaire. The investigators
will measure attitudes about body satisfaction and eating.
Lastly, the individuals will have their questionnaires checked by a member of the research
team to ensure completion. After signing the consent form and turning in their
questionnaires, participants will receive their group assignment. They will either be
assigned to the first intuitive eating group (IE1) or the second intuitive eating group
(IE2).
If they were assigned to the IE1 group, they will complete their first class immediately
following the baseline assessment at the beginning of the Spring 2019 semester.
If they are assigned to the IE2 group, they will complete their first intuitive eating class
the week after IE1's 5-week intuitive eating course has been completed.
Each group will be able to attend up to 5 intuitive eating sessions that are 60 minutes long
for a total of 5 weeks. Participation in the intuitive eating program will be tracked by
documenting presence or absence at each intuitive eating session. A member of the research
team will be responsible for documenting this and also checking fidelity to the curriculum.
An additional baseline assessment will be conducted on the IE2 Group at the beginning of
their first intuitive eating class. This assessment protocol will be identical to the one
they attended, as described above, on the first day the IE1 group began their intuitive
eating course. The assessment should not take longer than 30 minutes.
End-of-study assessments will be completed on the last day of the participant's intuitive
eating program. The assessment should not take longer than 30 minutes. At the last intuitive
eating classes for each session, the investigators will measure attitudes about body
satisfaction and eating, height, and weight.
A program evaluation survey will be passed out during the end of the last intuitive eating
class for both IE1 and IE2. This is to assess the effectiveness of the intuitive eating
program and to receive feedback from participants on where the investigators can improve this
program. This program evaluation is included with this application.
IE1 will be asked to come back for an additional final assessment and feedback session on the
last session day of IE2's intuitive eating course. IE1 will be in a separate room where they
will have the chance to discuss and provide program feedback to the Graduate and
Undergraduate Research Assistants. They will also fill out a program evaluation survey (for
the second time), as described above. IE2 will be in the room where their last session just
concluded where they will fill out the final survey, as described above, and will have their
height and weight measured. Once both groups are finished in each room, they will switch and
go through the same protocol as the last group did in that room
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03117374 -
Impact of Web-based School Nutrition Intervention to Increase Fruits, Vegetables and Dairy
|
N/A | |
Completed |
NCT04025099 -
Internal Cues Versus External Cues for Eating and Activity
|
N/A | |
Recruiting |
NCT06111040 -
Nurturing Needs Study: Parenting Food Motivated Children
|
N/A | |
Completed |
NCT05485168 -
Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women
|
N/A | |
Completed |
NCT03241121 -
Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
|
N/A | |
Completed |
NCT03850990 -
Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss
|
N/A | |
Completed |
NCT02470949 -
Influence of a Monopoly Game on Subtle Behaviors
|
N/A | |
Recruiting |
NCT01863212 -
The Role of the FTO Gene in Reward System Activation in Obese and Healthy Subjects
|
N/A | |
Completed |
NCT02729675 -
Innovative Approaches to Increase F&V Intake Thru Worksites
|
Phase 2 | |
Completed |
NCT05405244 -
Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for T2DM
|
Phase 3 | |
Completed |
NCT04971811 -
Effects of Energy Density on Self-served Snacks in Preschool Children
|
N/A | |
Completed |
NCT05019872 -
Al Dente or Well Done? The Eating Rate of a Pasta Meal Modified by Texture
|
N/A | |
Completed |
NCT04605224 -
Effectiveness of a Culinary Class on Food Literacy and Eating Behaviours of Francophone High School Students
|
||
Not yet recruiting |
NCT06448117 -
Mind Nutrition Study: Nutrition in the Prevention of Depressiveness and Sustaining Work Ability
|
N/A | |
Recruiting |
NCT04526743 -
Eating Behavior and Weight Trajectory After Bariatric Surgery
|
||
Active, not recruiting |
NCT05026411 -
Food Reward Circuit Change by Orthodontics
|
N/A | |
Completed |
NCT05173311 -
Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance
|
N/A | |
Completed |
NCT05149066 -
#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents
|
N/A | |
Completed |
NCT03779321 -
Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects
|
N/A | |
Recruiting |
NCT06108128 -
Food for Thought: Executive Functioning Around Eating Among Children
|
N/A |