Obesity, Childhood Clinical Trial
Official title:
Effective Training Models for Implementing Health-Promoting Practices Afterschool
NCT number | NCT04009304 |
Other study ID # | 6928483 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | September 2017 |
Verified date | July 2019 |
Source | Harvard School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study of the dissemination of the Out-of-school Nutrition and Physical Activity Initiative will utilize a 3-arm group-randomized control trial to establish the effectiveness of two learning collaborative training models (e.g. train-the-trainer in-person vs. online) for an evidence-based out-of-school time (OST) nutrition and physical activity intervention. The study will compare sites that receive the training models with a control group. Investigators will work with YMCA leadership to recruit 45 demographically diverse YMCA OST sites from across the country. Sites will be matched on racial/ethnic composition, proportion of students eligible for free or reduced price meals, program enrollment, urban/rural/suburban setting, and physical activity and food service facilities available. One-third of the sites will be randomized to participate in the online training over the school year, one-third will participate in the in-person train-the-trainer model, and one-third will serve as controls. After randomization, in fall 2016, teams of YMCA OST directors and line staff will be invited to participate in the OSNAP learning collaborative trainings. The intervention follows the social ecological model with activities targeting multiple levels of change—school district/program sponsor, OST site, interpersonal, and individual—and emphasizing on adoption of the following OSNAP goals: ban sugar-sweetened drinks from snacks served and brought in from outside the snack program; offer water as a drink at snack every day; offer a fruit or vegetable option every day at snack; ban foods with trans fats from snacks served; serve whole grains; offer 30 minutes of physical activity to all children daily; offer 20 minutes of vigorous physical activity to all children 3 times per week; and eliminate television, movies, and non-educational screentime. Sessions are designed consistent with the Institute for Healthcare Improvement Breakthrough Series Collaborative model and use constructs from social cognitive theory—knowledge and skill development coupled with action planning—to drive environmental and behavior change. Teams of afterschool staff will use the Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT), decision aids, policy writing guides, and other resources available at www.osnap.org to set data-driven goals and implement discrete practice, policy, and communication action steps throughout the year. Staff will also receive training on the Food & Fun After School curriculum available at foodandfun.org.
Status | Completed |
Enrollment | 113 |
Est. completion date | September 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Staff from afterschool sites that are run by the YMCA - Staff from afterschool sites that serve elementary age children - Staff from afterschool sites that run programming for the duration of the school year Exclusion Criteria: - Staff from afterschool sites that have already had experience implementing the OSNAP intervention |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Harvard School of Public Health |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost of the implementation strategy | Data on personnel, travel, and material costs collected via activity logs and administrative records | Measured up to 1 year after baseline | |
Other | Reach: number of children and afterschool staff impacted by each implementation strategy | Collected on registration forms and via administrative records | Measured at baseline | |
Primary | Change from baseline in nutrition and physical activity goals met (aggregate score) | Effectiveness of the intervention will be measured with the Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT)—an observational measure of nutrition and physical activity practices that site staff complete for one week before and after the intervention. Our team validated the tool with OST staff similar to those proposed to complete the measure in this study, establishing criterion validity for physical activity and nutrition outcomes with correlations ranging from 0.56 to 0.85 when compared with accelerometry and direct observation of dietary intake. Minimum goals possible: 0; Maximum goals possible: 9 Higher values represent better outcomes |
Measured pre/post about 6 months apart | |
Secondary | Change from baseline in % of days offering physical activity, screentime, fruits and vegetables, water, juice, whole grains, and sugary drinks from outside the program | Using same Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT measure) - components of aggregate score Minimum days possible: 0%; Maximum days possible: 100% Higher values represent better outcomes | Measured pre/post about 6 months apart |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
Active, not recruiting |
NCT06259539 -
A YouTube Curriculum for Children With Autism and Obesity
|
N/A | |
Completed |
NCT03533621 -
Gut Microbiome, Adiposity, and Probiotics (GMAP)
|
N/A | |
Completed |
NCT03641521 -
A Trial to Increase Child Vegetable Intake Through Behavioral Strategies
|
N/A | |
Completed |
NCT05563311 -
Functional Assessment and Sleep Apnea in Obese Children and Adolescents
|
N/A | |
Completed |
NCT03575884 -
Fit 5 Kids Screen Time Reduction Curriculum for Latino Preschoolers
|
N/A | |
Terminated |
NCT03586544 -
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
|
Phase 4 | |
Completed |
NCT04628897 -
Physical Activity and the Home Environment in Preschool-aged Children in Urban Bangladesh
|
||
Completed |
NCT03399617 -
SPOON: Sustained Program for Improving Nutrition - Guatemala
|
N/A | |
Enrolling by invitation |
NCT06265597 -
The Effect of Healthy Nutrition and Yoga Program on Obese Children
|
N/A | |
Active, not recruiting |
NCT03843424 -
Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers
|
N/A | |
Completed |
NCT03170700 -
Online Videos and New Feeding Content to Enhance a Current EFNEP Program
|
N/A | |
Not yet recruiting |
NCT06464497 -
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
|
N/A | |
Enrolling by invitation |
NCT05551650 -
El Sendero: Pathways to Health Study
|
||
Completed |
NCT04346433 -
Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function
|
N/A | |
Recruiting |
NCT03963557 -
Cognitive Function and Body Mass Index in Children and Adolescents
|
||
Completed |
NCT03495310 -
Effect of Mindfulness on Stress, Appetite Hormones and Body Weight of Obese Schoolchildren. Controlled Clinical Trial
|
N/A | |
Recruiting |
NCT06028113 -
A Novel Obesity Prevention Program for High-Risk Infants in Primary Care
|
Phase 2 | |
Active, not recruiting |
NCT05465057 -
"HIIT Med Kiloene".
|
N/A | |
Completed |
NCT03069274 -
Sugar-sweetened Beverage Intake Substitution by Water to Prevent Overweight in Mexican Children
|
N/A |