ObesityNCT05302830
Effectiveness of the Snackability Smartphone Application to Improve Quality of the Snack Intake, General Diet Quality, and Weight Among College Students
A study testing Snackability app in people with Obesity and Diet, Healthy, run by Florida International University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diet, Healthy
- What is being tested?
- Snackability app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Nutrition students
- Enrolled in a weight loss and/or nutrition program
- Taking medications known to influence weight
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
Official title: 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.
- Conditions
- Obesity, Diet, Healthy
- Being tested
- Snackability app, Control group
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snackability appBehavioural
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).
Control groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Snackability app | Experimental | 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). Receives: Behavioral: Snackability app |
| Control group | Placebo comparator | 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. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general diet quality
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.
Measured: 12 weeks
Change in snack quality
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.
Measured: 12 weeks
Change in snack patterns
The change in snack patterns was assessed by responses to the survey about intake of snacks completed at baseline and 12 weeks
Measured: 12 weeks
Secondary outcomes (1)
Change in weight
The change in weight was measured between weight measured at baseline and weight measured 12 weeks later
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 Jun 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Palacios, PhD, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302830
- Sponsor's protocol ID
- 20-0275
- Status last verified
- Apr 2023
- First submitted
- 12 Mar 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Snackability Trial
- ClinicalTrials.gov ID
- NCT05302830
- Acronym / sponsor ID
- 20-0275
- Conditions
- Obesity, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Snackability app | Experimental | Behavioral: Snackability appThis 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). |
| Control group | Placebo comparator | Behavioral: Control groupThe 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Nutrition students
- Enrolled in a weight loss and/or nutrition program
- Taking medications known to influence weight
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snackability appThis 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). | Behavioural | Snackability app |
| Control groupThe 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. | Behavioural | Control group |
Primary outcome
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.
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.
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
1 secondary outcome
Change in weight
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snackability app in people with Obesity and Diet, Healthy, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general diet quality (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.