Pediatric Obesity Clinical Trial
— FFFOfficial title:
Cooking With Kids 2.0: Plus Parents and Play
| NCT number | NCT02491294 |
| Other study ID # | 12-3278H |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 1, 2012 |
| Est. completion date | July 14, 2018 |
| Verified date | May 2021 |
| Source | Colorado State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Fuel for Fun: Cooking with Kids Plus Parents and Play (FFF), is an integrated research, extension, and education project targeting 4th grade students. Its long-term goal of reducing the risk of childhood obesity will be addressed by promoting healthful food and activity environments, policies and behaviors through: 1) building and testing the efficacy of a 4th grade comprehensive school- and family-based intervention, 2) applying it to an after-school setting to broaden its reach, and, 3) disseminating both versions through outreach.
| Status | Completed |
| Enrollment | 2640 |
| Est. completion date | July 14, 2018 |
| Est. primary completion date | July 14, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 7 Years to 12 Years |
| Eligibility | Inclusion Criteria: - all students enrolled in participating classrooms are invited to participate Exclusion Criteria: - none |
| Country | Name | City | State |
|---|---|---|---|
| United States | Leslie Cunningham-Sabo | Fort Collins | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Colorado State University | Penn State University, Poudre School District, Rochester Institute of Technology, Thompson School District |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Fruit and Vegetable Consumption at School Lunch | using observation and digital photography we will assess student selection and consumption of fruits and vegetables during school lunch; measured at the grade level | assessed 4 times each 9-month school year; once prior to intervention beginning (i.e., September), approximately 10 weeks and then 20 weeks later, and finally once after the intervention ends (i.e., May). | |
| Primary | Change in Student Activity Level | Using accelerometers, we will assess a week of activity; 3 of 8 participating schools have been randomized to participate in this data collection | assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September) | |
| Secondary | Body Mass Index | using a standard protocol, we will measure height and weight of all participating students and then calculate BMI z-scores | assessed 3 times over 1 year; initially prior to the intervention beginning (i.e., September), a 2nd time once the intervention ends (i.e., May), and then again at the beginning of the following school year (i.e., September) |
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