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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
272

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Behavioral: 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).
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Florida International University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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