Simple, personalized behavioral interventions as a means to modify diet quality in college students: A randomized intervention
| ISRCTN | ISRCTN53920728 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53920728 |
- Submission date
- 19/08/2022
- Registration date
- 24/08/2022
- Last edited
- 08/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Diet is an important factor necessary for good health. College students are typically healthy, but they often struggle to maintain a good diet once they arrive at their college. The purpose of this research study is to determine if having college students select simple dietary behavior changes for themselves can successfully improve the quality of their diets, compared to just receiving general advice.
Who can participate?
Students will be eligible to participate in this study if 18 to 25 years of age, enrolled full time as a student of your university, fluent in English, do not have any medical conditions or allergies that require modification of diet, or struggle with disordered eating practices.
What does the study involve?
If eligible, participants will complete initial surveys and two diet recalls within a week's time, with help from members of the research team. After completing these initial surveys, participants will be assigned to participate in either the experimental or control group. In the experimental group, participants will be shown a list of seven simple dietary behaviors and asked to select the two behaviors they would most like to follow for the next four weeks. They will then receive a laminated card for each chosen behavior which are then attached to their key chain and carried for the next four weeks as a reminder of their selected dietary behaviors. They may also receive reminder text messages each week from the research team. The control group will receive a link to the current Dietary Guidelines for Americans and asked to consider these guidelines in relation to their diet. Those in the control group will not receive laminated cards or specific instructions on dietary behaviors. After four weeks have passed, all participants will again complete two dietary recalls within a week's time frame. At this point the study is considered over, but after four more weeks have passed, participants will again be contacted to complete two final dietary recalls as well as close out surveys similar to what they completed in the beginning.
All study procedures will occur virtually over 9 weeks. The time required to complete all surveys will be approximately 2 hours and 40 minutes when spread out over the study period. The study will be conducted remotely, with the research team located on campus at UCI.
What are the possible benefits and risks of participating?
Possible benefits participants may experience from the procedures described in this study include becoming more informed about how to improve diet quality. Possible risks and discomforts associated with the study include: anticipated discomfort with answering questions about one's personal life, including finances and dietary practices. In addition, participants will be providing information about their diet, and this may cause some anxiety for feeling judged or experiencing negative feelings regarding the quality of their diet. Furthermore, participants will be asked to perform specific behaviors that some may consider to be cumbersome or a burden in light of student-related duties.
Where is the study run from?
University of California, Irvine (USA)
When is the study starting and how long is it expected to run for?
July 2022 to April 2023
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dustin Moore, dustinmm@uci.edu
Contact information
Principal Investigator
9210 Via Balboa Circle
Buena Park
90620
United States of America
| Phone | +1 8056572757 |
|---|---|
| dustinmm@uci.edu |
Study information
| Study design | Multicenter interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | 42255 PIS 01Mar2021.pdf |
| Scientific title | Personalized intention tags selected by college students, and meant to be attached to the students keys, with a four week trial period to observe if diet quality will improve, compared to general nutrition information provided to a control group of similar college students. |
| Study acronym | SMPLDIET |
| Study hypothesis | The aim of the randomized controlled trial among college students is to evaluate whether or not simple, behavioral intention statements that are selected by the students and carried as keychain tags can result in improved diet quality, compared to general nutrition advice. |
| Ethics approval(s) | Approved 18/07/2022, University of California Irvine Institutional Review Board (Office of Research, 160 Aldrich Hall, Irvine, CA, 92697-7600, USA; +1 949-824-6662; cshindle@uci.edu), ref: UCI IRB #963 |
| Condition | Diet quality among college students |
| Intervention | One group of students will be given a list of simple behavior change interventions, and asked to select two, which they will adhere to for the duration of the study. These selected behavior changes will be printed out onto laminate tags and given to students with the intention to be placed on their keys. The second group will be given a link and guide to MyPlate and the Dietary Guidelines for Americans, which they will also be asked to read without specific dietary guidance. Both groups will complete baseline and follow-up surveys that collect information on demographics, current stress levels, willingness to change behavior, and diet quality, with the principal outcome being how the intervention affects diet quality. The intervention will run for a duration of four weeks, with an additional follow-up at eight weeks from baseline. The control arm of the study will be undergo data collection procedures at the same time points. Randomization: Using the NIH NCI Clinical Trial Randomization Tool (https://ctrandomization.cancer.gov/home/). This generated a randomized list of allocations. As participants are recruited and deemed eligible, they will be sequentially assigned the allocation determined by this list. |
| Intervention type | Mixed |
| Primary outcome measure | Diet quality as measured by the Healthy Eating Index 2015, using data collected from the Automated Self-Administered 24-hour Dietary Assessment Tool at baseline, week 4, and week 8 |
| Secondary outcome measures | Feasibility will be assessed using a 7 question Likert scale survey developed by the researchers at week 8. |
| Overall study start date | 18/07/2022 |
| Overall study end date | 15/04/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 131 |
| Participant inclusion criteria | 1. Between the ages of 18 and 25 years 2. Fluent in English 3. Enrolled full time at a university as a student. |
| Participant exclusion criteria | 1. Those with severe food allergies, medical conditions that require dietary modification 2. Those at risk for disordered eating or eating disorders 3. Those considered to already have a high diet quality in line with dietary recommendations |
| Recruitment start date | 29/08/2022 |
| Recruitment end date | 31/03/2023 |
Locations
Countries of recruitment
- United States of America
Study participating centres
92697
United States of America
Long Beach
90840
United States of America
Sponsor information
University/education
653 E Peltason Drive
Irvine
92697
United States of America
| Phone | +1 (949) 824-6207 |
|---|---|
| ebakou@uci.edu | |
| Website | https://publichealth.uci.edu/ph/_contact/administration |
"ROR" |
https://ror.org/04gyf1771 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/02/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Once the manuscript has been written at the conclusion of the study, we plan to submit the paper for publication at a journal that focuses on college student health or nutrition-related education practices. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be stored in a non-publicly available repository, but at a later point may become available if requested. This will be a password protected repository through the school public health at UC Irvine, with access given to only members of the research team, for the purpose of analyzing the data for publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/03/2021 | 23/08/2022 | No | Yes |
Additional files
Editorial Notes
08/03/2023: The following changes were made to the trial record:
1. The overall trial end date has been changed from 01/05/2023 to 15/04/2023 and the plain English summary updated accordingly.
2. Total final enrolment added.
23/08/2022: Trial's existence confirmed by UC Irvine
