Environment Related DiseaseNCT02889198
A Pilot Study Evaluating Go NAP SACC's Web-based Nutrition Tool for Child Care
A study testing Go NAP SACC in people with Environment Related Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Environment Related Disease
- What is being tested?
- Go NAP SACC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Child Care Centers must have a quality rating of 2-5 stars OR be licensed as GS110-106 (faith-based and exempt from rating), serve lunch and a snack, and have 3-4 year old classrooms and 2 preschool teacher willing to participate.
- Teachers must teach in the 3-4 year old classrooms.
- Center directors and teachers must be able to read English.
Who cannot join
- Child Care Centers cannot have participated in NAP SACC within the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Go NAP SACC: A Pilot Study Evaluating the Nutrition Tool of the Web-based Tool Based on the NAP SACC Program
The purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the course of 4 months.
Read the detailed description
National data show that many children, even as young as 2-5 years old, have adopted unhealthy eating patterns and are overweight/obese. Interventions targeting early childhood are critical for reversing these trends. More than half of 3-6 year olds in the US are enrolled in center-based child care programs, where they spend more than 25 hours per week. For these children, the center's nutrition environment can influence developing preferences and habits and thereby, weight status. The Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) was developed in 2002 to help child care providers improve their food and physical activity environments. Evaluations of NAP SACC have shown it to be efficacious, but the program's reliance on trained technical assistance professionals and in-person delivery limits its potential for large-scale dissemination, especially in low-resourced rural areas. Go NAP SACC was developed to overcome this challenge by providing tailored web-based tools and resources that allow child care providers to complete more of the program on their own. This study will evaluate Go NAP SACC to determine if web-based delivery can broaden dissemination of the program, particularly in low-resourced rural areas.
This project will use a randomized controlled design to evaluate the impact of Go NAP SACC on centers' nutrition environments. A sample of 40 child care centers will be recruited to take part. Participating centers will be randomized (1:1) into one of two arms: immediate access (intervention) or delayed access (control). Measures will be collected at two time points, baseline and post-intervention (4 months later), to assess change in centers' nutrition environment scores.
The sample of 40 licensed centers will be recruited from rural counties in North Carolina. To facilitate recruitment, county-level Smart Start partnerships (local organizations that have existing relationships with child care programs) will be asked to share information about the study with their local centers and compile a list of those who might be interested in participating. Then, trained research assistants will follow-up with interested centers by telephone to confirm interest and eligibility. To be eligible, a center must serve 3-5 year old children and have 2 preschool teachers willing to take part in measures along with the center director, have a quality rating of 2-5 stars (or be exempt from ratings), and not have participated in NAP SACC in the last 6 months. Centers directors will complete a memorandum of understanding and informed consent; and teachers will be given informational fact sheets (but will not be asked to sign consent).
Centers will be randomized following their completion of baseline measures. Those randomized into the intervention arm will be given immediate access to Go NAP SACC online tools. To facilitate their use, technical assistance providers from the local Smart Start partnerships will provide an in-person orientation to each center director to help them register, learn to navigate the website, and review a timeline for implementation. Center directors will then have 4 months to complete the self-assessment, select goals to work on, create action plans, and implement those plans using resources from the tips and materials library. Technical assistance staff will provide brief monthly check-ins (by telephone or email) to prompt continued efforts. Centers randomized into the control group will receive the same access and support just 4-6 months later (once post-intervention measures are complete).
To evaluate the impact of Go NAP SACC, centers' nutrition environments will be assessed at two timepoints: baseline and post-intervention. These assessments will use the self-report version of the Environment and Policy Assessment and Observation (EPAO-SR), which uses self-administered surveys completed by directors and preschool teachers. The EPAO-SR will be modified to focus solely on the nutrition environment (eliminating physical activity and screen time items).
The statistical analysis will compare the differences in mean change in centers' nutrition environment scores from pre- to post-intervention between intervention and control groups. The analysis will assess change in the overall nutrition environment score, as well as changes in each of the seven environmental sub-components. Analyses will involve testing of the hypotheses under the intent-to-treat (ITT) principle using SAS v.9.2 and Generalized Linear Modeling (PROC GLM). Use of PROC GLM, instead of a simple t-test, will allow us to control for key characteristics (e.g., technical assistance staff, quality star rating, participation in Child and Adult Care Food Program). To further explore the effect of the intervention, the investigators will fit Generalized Linear Mixed Models that: 1) adjust for baseline variables distributed differently between the intervention and comparison groups; 2) test interaction terms between the treatment group and other covariates; and 3) examine completers only.
NOTE DEVIATION: While the anticipated sample was 40 child care centers, only 33 enrolled, 31 of which provided sufficient baseline and follow-up data to be included in the analysis.
- Conditions
- Environment Related Disease
- Being tested
- Go NAP SACC
- Keywords
- web-based tool, child, preschool, nutrition, implementation, child care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go NAP SACCBehavioural
Go NAP SACC is a suite of online tools designed to help child care programs improve their nutrition environment. Tools include: self-assessment, goal setting, action planning, and tips and materials. In addition to these online tools, local technical assistance providers offer center directors an orientation on how to use Go NAP SACC and minimal ongoing technical assistance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Centers in this group will be granted immediate access to the Go NAP SACC website following randomization with minimal support from a local technical assistance provider. The center director will have 4 months to use Go NAPSACC tools. Receives: Behavioral: Go NAP SACC |
| Control group | No intervention | During the study, centers in this group will receive no intervention. However, they will be granted delayed access to the Go NAP SACC website and technical assistance support after post-intervention measures are collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EPAO-SR Scores from Baseline to Post-intervention
Nutrition-related environmental characteristics will be assessed using the EPAO-SR, integrating data from the center director, child care teachers, and trained staff (reviewing policy documents).Data from all components is used in scoring. Item responses are used to derive variables assessing compliance with 42 nutrition best practices (BPs). Each nutrition BP variable is scored on a 4-point scale (0-3), where higher scores indicate closer BP compliance. Nutrition BP variables are then sorted into one of 7 environmental components: foods provided (12), beverages provided (5), feeding practices (8), feeding environment (8), menus (1), education \& professional development (6), or policy (1). Environmental summary scores are calculated by averaging scores from relevant nutrition BP variables; hence, summary scores range from 0 to 3. An overall nutrition score is calculated by summing the 7 environmental summary scores; hence overall nutrition scores range from 0 to 21.
Measured: Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Environment Related DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Dianne S Ward, EdD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889198
- Sponsor's protocol ID
- 14-0931
- Status last verified
- Feb 2017
- First submitted
- 26 Aug 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ward DS, Vaughn AE, Mazzucca S, Burney R. Translating a child care based intervention for online delivery: development and randomized pilot study of Go NAPSACC. BMC Public Health. 2017 Nov 21;17(1):891. doi: 10.1186/s12889-017-4898-z.
PubMed 29162057
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Go NAP SACC: A Pilot Study Evaluating the Nutrition Tool of the Web-based Tool Based on the NAP SACC Program
- ClinicalTrials.gov ID
- NCT02889198
- Acronym / sponsor ID
- 14-0931
- Conditions
- Environment Related Disease
- Keywords
- web-based tool, child, preschool, nutrition, implementation, child care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Sep 2016 (estimated)
- 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 purpose of this project is to evaluate the effectiveness of Go NAP SACC (Get online with Nutrition and Physical Activity Self-Assessment for Child Care), a suite of web-based tools designed to help child care programs improve their nutrition environment (specifically classrooms serving 3-5 year olds) over the course of 4 months.
Detailed description
National data show that many children, even as young as 2-5 years old, have adopted unhealthy eating patterns and are overweight/obese. Interventions targeting early childhood are critical for reversing these trends. More than half of 3-6 year olds in the US are enrolled in center-based child care programs, where they spend more than 25 hours per week. For these children, the center's nutrition environment can influence developing preferences and habits and thereby, weight status. The Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) was developed in 2002 to help child care providers improve their food and physical activity environments. Evaluations of NAP SACC have shown it to be efficacious, but the program's reliance on trained technical assistance professionals and in-person delivery limits its potential for large-scale dissemination, especially in low-resourced rural areas. Go NAP SACC was developed to overcome this challenge by providing tailored web-based tools and resources that allow child care providers to complete more of the program on their own. This study will evaluate Go NAP SACC to determine if web-based delivery can broaden dissemination of the program, particularly in low-resourced rural areas.
This project will use a randomized controlled design to evaluate the impact of Go NAP SACC on centers' nutrition environments. A sample of 40 child care centers will be recruited to take part. Participating centers will be randomized (1:1) into one of two arms: immediate access (intervention) or delayed access (control). Measures will be collected at two time points, baseline and post-intervention (4 months later), to assess change in centers' nutrition environment scores.
The sample of 40 licensed centers will be recruited from rural counties in North Carolina. To facilitate recruitment, county-level Smart Start partnerships (local organizations that have existing relationships with child care programs) will be asked to share information about the study with their local centers and compile a list of those who might be interested in participating. Then, trained research assistants will follow-up with interested centers by telephone to confirm interest and eligibility. To be eligible, a center must serve 3-5 year old children and have 2 preschool teachers willing to take part in measures along with the center director, have a quality rating of 2-5 stars (or be exempt from ratings), and not have participated in NAP SACC in the last 6 months. Centers directors will complete a memorandum of understanding and informed consent; and teachers will be given informational fact sheets (but will not be asked to sign consent).
Centers will be randomized following their completion of baseline measures. Those randomized into the intervention arm will be given immediate access to Go NAP SACC online tools. To facilitate their use, technical assistance providers from the local Smart Start partnerships will provide an in-person orientation to each center director to help them register, learn to navigate the website, and review a timeline for implementation. Center directors will then have 4 months to complete the self-assessment, select goals to work on, create action plans, and implement those plans using resources from the tips and materials library. Technical assistance staff will provide brief monthly check-ins (by telephone or email) to prompt continued efforts. Centers randomized into the control group will receive the same access and support just 4-6 months later (once post-intervention measures are complete).
To evaluate the impact of Go NAP SACC, centers' nutrition environments will be assessed at two timepoints: baseline and post-intervention. These assessments will use the self-report version of the Environment and Policy Assessment and Observation (EPAO-SR), which uses self-administered surveys completed by directors and preschool teachers. The EPAO-SR will be modified to focus solely on the nutrition environment (eliminating physical activity and screen time items).
The statistical analysis will compare the differences in mean change in centers' nutrition environment scores from pre- to post-intervention between intervention and control groups. The analysis will assess change in the overall nutrition environment score, as well as changes in each of the seven environmental sub-components. Analyses will involve testing of the hypotheses under the intent-to-treat (ITT) principle using SAS v.9.2 and Generalized Linear Modeling (PROC GLM). Use of PROC GLM, instead of a simple t-test, will allow us to control for key characteristics (e.g., technical assistance staff, quality star rating, participation in Child and Adult Care Food Program). To further explore the effect of the intervention, the investigators will fit Generalized Linear Mixed Models that: 1) adjust for baseline variables distributed differently between the intervention and comparison groups; 2) test interaction terms between the treatment group and other covariates; and 3) examine completers only.
NOTE DEVIATION: While the anticipated sample was 40 child care centers, only 33 enrolled, 31 of which provided sufficient baseline and follow-up data to be included in the analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Go NAP SACCCenters in this group will be granted immediate access to the Go NAP SACC website following randomization with minimal support from a local technical assistance provider. The center director will have 4 months to use Go NAPSACC tools. |
| Control group | No intervention | –During the study, centers in this group will receive no intervention. However, they will be granted delayed access to the Go NAP SACC website and technical assistance support after post-intervention measures are collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Child Care Centers must have a quality rating of 2-5 stars OR be licensed as GS110-106 (faith-based and exempt from rating), serve lunch and a snack, and have 3-4 year old classrooms and 2 preschool teacher willing to participate.
- Teachers must teach in the 3-4 year old classrooms.
- Center directors and teachers must be able to read English.
Key exclusion criteria (1 listed)
- Child Care Centers cannot have participated in NAP SACC within the last 6 months.
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 |
|---|---|---|
| Go NAP SACCGo NAP SACC is a suite of online tools designed to help child care programs improve their nutrition environment. Tools include: self-assessment, goal setting, action planning, and tips and materials. In addition to these online tools, local technical assistance providers offer center directors an orientation on how to use Go NAP SACC and minimal ongoing technical assistance. | Behavioural | Intervention group |
Primary outcome
Change in EPAO-SR Scores from Baseline to Post-intervention
Time frame: Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention)
Nutrition-related environmental characteristics will be assessed using the EPAO-SR, integrating data from the center director, child care teachers, and trained staff (reviewing policy documents).Data from all components is used in scoring. Item responses are used to derive variables assessing compliance with 42 nutrition best practices (BPs). Each nutrition BP variable is scored on a 4-point scale (0-3), where higher scores indicate closer BP compliance. Nutrition BP variables are then sorted into one of 7 environmental components: foods provided (12), beverages provided (5), feeding practices (8), feeding environment (8), menus (1), education \& professional development (6), or policy (1). Environmental summary scores are calculated by averaging scores from relevant nutrition BP variables; hence, summary scores range from 0 to 3. An overall nutrition score is calculated by summing the 7 environmental summary scores; hence overall nutrition scores range from 0 to 21.
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 17 Feb 2017.
- Derived from this study: PubMed 29162057Ward DS, Vaughn AE, Mazzucca S, Burney R. Translating a child care based intervention for online delivery: development and randomized pilot study of Go NAPSACC. BMC Public Health. 2017 Nov 21;17(1):891. doi: 10.1186/s12889-017-4898-z.
- 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.
Dianne S Ward, EdD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go NAP SACC in people with Environment Related Disease, run by University of North Carolina, Chapel Hill 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 3 inclusion and 1 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 17 Feb 2017. 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. 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 EPAO-SR Scores from Baseline to Post-intervention (time frame: Measures collected at baseline (2-4 weeks prior to the intervention) and post-intervention (1-3 weeks following the intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02889198, which also lists 1 linked publication.
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 17 Feb 2017.