Obesity Clinical Trial
Official title:
Snackability Trial
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 |
Verified date | April 2023 |
Source | Florida International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Florida International University | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida International University |
United States,
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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