- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05302830
Effectiveness of the Snackability Smartphone Application to Improve Quality of the Snack Intake, General Diet Quality, and Weight Among College Students
April 12, 2023 updated by: Cristina Palacios, PhD, Florida International University
Snackability Trial
The Snackability was a two-arm, 12-week randomized control trial among 272 overweight college students.
Participants were equally randomized to the intervention group (access to the app) or control group (no access to the app).
Diet and weight were assessed at baseline, at 4 weeks, at 8 weeks, and at 12 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
272
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33199
- Florida International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Overweight or obese college students-
- Aged 18-24 years
- Owner of a smartphone with Android or iOS platforms with access to an internet connection to use the app
- Willingness to participate in a clinical trial of 3 months and complete assessments at baseline and every 4 weeks at home
Exclusion Criteria:
- Nutrition students
- Enrolled in a weight loss and/or nutrition program
- Taking medications known to influence weight
- Pregnant or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Snackability app
This app allows user to search for a snack (scan barcode or type snack name), add a portion size consumed based on a portion size guide, and then provide a snack score and breakdown scores with a specific feedback message about the score.25
A score ranging from 0-10 points was designed taking into account the first ingredient, the nutrient standard by portion size, and the processing of foods (score ranging from -1 to 1 was subtracted or added depend on processed food classification).
The final score ranged from -1 to 11 points.
The higher the score, the more compliant it is to the guideline; therefore, the healthier the snack is.
The app also provides gamification features as self-motivation (level up and achievement gained) and reporting features as goal-setting and self-monitoring (average daily score and consumed snack history).
|
This app allows user to search for a snack (scan barcode or type snack name), add a portion size consumed based on a portion size guide, and then provide a snack score and breakdown scores with a specific feedback message about the score.25
A score ranging from 0-10 points was designed taking into account the first ingredient, the nutrient standard by portion size, and the processing of foods (score ranging from -1 to 1 was subtracted or added depend on processed food classification).
The final score ranged from -1 to 11 points.
The higher the score, the more compliant it is to the guideline; therefore, the healthier the snack is.
The app also provides gamification features as self-motivation (level up and achievement gained) and reporting features as goal-setting and self-monitoring (average daily score and consumed snack history).
|
|
Placebo Comparator: Control group
The control group received a 1-page with information on what is a healthy snack from the USDA: https://www.fns.usda.gov/cn/tools-schools-focusing-smart-snacks.
They were given access to the app after the 12-week study period.
|
The control group received a 1-page with information on what is a healthy snack from the USDA: https://www.fns.usda.gov/cn/tools-schools-focusing-smart-snacks.
They were given access to the app after the 12-week study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in general diet quality
Time Frame: 12 weeks
|
The change in diet quality was measured using the Healthy Eating Index (HEI) 2015, which was calculated from three 24-h recalls (2 on weekdays and 1 during the weekend) collected at baseline and 12 weeks.
|
12 weeks
|
|
Change in snack quality
Time Frame: 12 weeks
|
The change in snacks consumed was recorded from the 24-h recalls collected at baseline and again at 12 months.
For each snack consumed at each time point, a score was calculated using the Snackability scoring system.
|
12 weeks
|
|
Change in snack patterns
Time Frame: 12 weeks
|
The change in snack patterns was assessed by responses to the survey about intake of snacks completed at baseline and 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in weight
Time Frame: 12 weeks
|
The change in weight was measured between weight measured at baseline and weight measured 12 weeks later
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2020
Primary Completion (Actual)
July 15, 2021
Study Completion (Actual)
July 15, 2021
Study Registration Dates
First Submitted
March 12, 2022
First Submitted That Met QC Criteria
March 21, 2022
First Posted (Actual)
March 31, 2022
Study Record Updates
Last Update Posted (Actual)
April 13, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 20-0275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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