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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05302830
Other study ID # 20-0275
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2020
Est. completion date July 15, 2021

Study information

Verified date April 2023
Source Florida International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date July 15, 2021
Est. primary completion date July 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
United States Florida International University Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 weeks
Primary 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. 12 weeks
Primary 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 12 weeks
Secondary Change in weight The change in weight was measured between weight measured at baseline and weight measured 12 weeks later 12 weeks
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