OverweightCCWSNCT01921842
Child Care Wellness Study on Nutrition and Physical Activity
A study testing NAP-SACC Child Care Wellness Program in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- NAP-SACC Child Care Wellness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Aug 2010
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In each of the three geographical areas (NC, CA, CT), two pairs of community-based child care centers in urban areas with English-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy.
Who cannot join
- If the randomly selected child care center has an open case of child abuse or neglect.
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Care Centers
Wilmington, North Carolina, 28401
About this study
Official title: Promoting Nutrition and Physical Activity in Child Care Centers
The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.
Read the detailed description
The broad, long term goal is to develop a reproducible nutrition and physical activity intervention which utilizes child care consultant nutrition specialists to reduce the risk of overweight among children in regulated out-of-home child care. The objectives are:
- To train Child Care Health consultants (CCHCs) to become specialists in nutrition consultation in child care such that they will increase their daily consultation activities on nutrition, physical activity, and childhood overweight,
- To increase child care staff and parental knowledge of and positive attitudes toward providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers.,
- To strengthen child care center policies, procedures, practices and behaviors, regarding providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers, and
- To improve dietary intake and levels of physical activity, and to prevent increases in overweight and the risk of overweight as determined by body mass indexes among children in out-of-home child care centers.
- Conditions
- Overweight, Obesity
- Being tested
- NAP-SACC Child Care Wellness Program
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAP-SACC Child Care Wellness ProgramBehavioural
Nutrition And Physical activity Self-Assessment for Child Care
| Study group | Role | What they receive |
|---|---|---|
| Nutrition and Physical Activity Training | Experimental | NAP-SACC Child Care Wellness program administered in year 1 of study Receives: Behavioral: NAP-SACC Child Care Wellness Program |
| Delayed Intervention Group | Other | NAP-SACC Child Care Wellness Program is administered in year 2 of study. Receives: Behavioral: NAP-SACC Child Care Wellness Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nutrition and Physical Activity Policies
Determine if the use of a Nurse Child Care Health Consultant changes nutrition and physical activity policies at child care centers using criteria based on the national standards identified from resources such as NAEYC accreditation guidelines, Child and Adult Care Food Program (CACFP) policies and requirements, and the joint APHA/AAP publication Caring for our Children (American Academy of Pediatrics, American Public Health Association \& National Resource Center for Health and Safety in Child Care, 2002; 1992). If written policies were present, they were compared to the gold-standard criteria from the national resource material and assigned a rating of either none (no written policies), poor (written policies fail to meet either state regulatory criteria or national standards), adequate (meets state regulatory criteria but not all of the national standards), or excellent (meets all of the national criteria present).
Measured: Baseline, Year 1, Year 2
Secondary outcomes (1)
Change in Nutrition and Physical Activity Behaviors
Determine if the use of a Nurse Child Care Health Consultant changes nutrition and physical activity behaviors at child care centers using the NAP SACC instrument intervention tool which consists of fifteen different areas of interest (9 nutrition and 6 physical activity) with several items each. The total number of items scored, 34, evaluate the center's environment with regard to support of healthy eating and regular physical activity. The instrument scoring is at one of four levels moving from minimal to best practice.
Measured: Baseline, Year 1, Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionAug 2010
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 OverweightStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, University of California, San Francisco, HRSA/Maternal and Child Health Bureau
- Responsible party
- Sponsor
- Investigators
- Jonathan B Kotch, MD, Principal investigator, University of North Carolina in Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921842
- Sponsor's protocol ID
- 07-1861
- Other IDs
- R40MC08727
- Acronym
- CCWS
- Status last verified
- Aug 2013
- First submitted
- 7 Aug 2013
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alkon A, Crowley AA, Neelon SE, Hill S, Pan Y, Nguyen V, Rose R, Savage E, Forestieri N, Shipman L, Kotch JB. Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children's body mass index. BMC Public Health. 2014 Mar 1;14:215. doi: 10.1186/1471-2458-14-215.
PubMed 24580983
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Nutrition and Physical Activity in Child Care Centers
- ClinicalTrials.gov ID
- NCT01921842
- Acronym / sponsor ID
- CCWS / 07-1861
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Yale University, University of California, San Francisco, HRSA/Maternal and Child Health Bureau
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 Aug 2013 (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 study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.
Detailed description
The broad, long term goal is to develop a reproducible nutrition and physical activity intervention which utilizes child care consultant nutrition specialists to reduce the risk of overweight among children in regulated out-of-home child care. The objectives are:
- To train Child Care Health consultants (CCHCs) to become specialists in nutrition consultation in child care such that they will increase their daily consultation activities on nutrition, physical activity, and childhood overweight,
- To increase child care staff and parental knowledge of and positive attitudes toward providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers.,
- To strengthen child care center policies, procedures, practices and behaviors, regarding providing healthy foods, appropriate portions of foods, and appropriate levels of physical activity for young children in out-of-home child care centers, and
- To improve dietary intake and levels of physical activity, and to prevent increases in overweight and the risk of overweight as determined by body mass indexes among children in out-of-home child care centers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition and Physical Activity Training | Experimental | Behavioral: NAP-SACC Child Care Wellness ProgramNAP-SACC Child Care Wellness program administered in year 1 of study |
| Delayed Intervention Group | Other | Behavioral: NAP-SACC Child Care Wellness ProgramNAP-SACC Child Care Wellness Program is administered in year 2 of study. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- In each of the three geographical areas (NC, CA, CT), two pairs of community-based child care centers in urban areas with English-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy.
Key exclusion criteria (1 listed)
- If the randomly selected child care center has an open case of child abuse or neglect.
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 |
|---|---|---|
| NAP-SACC Child Care Wellness ProgramNutrition And Physical activity Self-Assessment for Child Care | Behavioural | Delayed Intervention Group, Nutrition and Physical Activity Training |
Primary outcome
Change in Nutrition and Physical Activity Policies
Time frame: Baseline, Year 1, Year 2
Determine if the use of a Nurse Child Care Health Consultant changes nutrition and physical activity policies at child care centers using criteria based on the national standards identified from resources such as NAEYC accreditation guidelines, Child and Adult Care Food Program (CACFP) policies and requirements, and the joint APHA/AAP publication Caring for our Children (American Academy of Pediatrics, American Public Health Association \& National Resource Center for Health and Safety in Child Care, 2002; 1992). If written policies were present, they were compared to the gold-standard criteria from the national resource material and assigned a rating of either none (no written policies), poor (written policies fail to meet either state regulatory criteria or national standards), adequate (meets state regulatory criteria but not all of the national standards), or excellent (meets all of the national criteria present).
1 secondary outcome
Change in Nutrition and Physical Activity Behaviors
Time frame: Baseline, Year 1, Year 2
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 13 Aug 2013.
- Derived from this study: PubMed 24580983Alkon A, Crowley AA, Neelon SE, Hill S, Pan Y, Nguyen V, Rose R, Savage E, Forestieri N, Shipman L, Kotch JB. Nutrition and physical activity randomized control trial in child care centers improves knowledge, policies, and children's body mass index. BMC Public Health. 2014 Mar 1;14:215. doi: 10.1186/1471-2458-14-215.
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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.
Jonathan B Kotch, MD principal investigator
University of North Carolina in 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 NAP-SACC Child Care Wellness Program in people with Overweight and Obesity, 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 1 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 13 Aug 2013. 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 Nutrition and Physical Activity Policies (time frame: Baseline, Year 1, Year 2). 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 NCT01921842, 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 13 Aug 2013.