ObesityNCT05656807
Evaluation of Child Care Staff Weight Management Program
A study testing Go NAPSACC Enhanced and Go NAPSACC in people with Obesity, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this 12-month cluster clinical trial is to evaluate if improving child care providers' health behaviors using an online provider weight management program elicits meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Go NAPSACC Enhanced and Go NAPSACC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 924 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Child Care Centers:
- Be open year-round
- Licensed with no plans to close in the next 2 years
- Been in operation for at least 1 year
- Have at least two classrooms serving children 2-5 years-old
- Serve at least lunch to the 2-5-year old children
Show all 17Show fewer
- Have no history of Go NAPSACC participation in the past 6 months
- Two 2-5-year-old classroom providers and 4 parents from each classroom must provide consent to participate in the study
- Child Care Providers (Directors and Teachers):
- Ability to provide informed consent.
- Age 18 years or older.
- Teacher only: Be a teacher in a 2-5-year-old classroom.
- Teacher only: Not pregnant, nor planning to become pregnant in the next year
- Children:
- Be in a classroom with a participating child care teacher.
- Be 2-5 years old.
- The consenting primary caregiver must be able to read English
Who cannot join
- Child Care Centers:
- Serve only non-English speaking families
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, 27599-7426
About this study
Official title: My Weight-their Weight: eHealth Intervention for Managing Obesity in Child Care Settings
The goal of this 12-month cluster clinical trial is to evaluate if improving child care providers' health behaviors using an online provider weight management program elicits meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment.
The study sample will include 84 child care centers. Including: 84 center directors, 168 2-5-year-old classroom teachers, 672 2-5-year old children.
Read more
Some centers will do only the online Nutrition and Physical Activity Self-Assessment for Child Care (Go NAPSACC) program. This program works with child care center directors to make changes to their center around child nutrition and physical activity to foster healthier habits for the children enrolled in their care. Other centers will do Go NAPSACC Enhanced. This will include center directors doing Go NAPSACC and 2-5 year old teachers doing an online weight management program with support.
Researchers will compare centers in Go NAPSACC with centers in Go NAPSACC Enhanced to see if there are greater improvements in children's diet quality and physical activity, as well as the nutrition and physical activity environment of centers in the Go NAPSACC Enhanced group. Additionally, they will see if there are greater improvements in teachers' weight, diet quality, and physical activity in centers using Go NAPSACC Enhanced.
Read the detailed description
This study is a two-group clustered randomized trial to evaluate if improving child care providers' health behaviors elicit meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment. The investigators will randomize (by center, 1:1 ratio) 84 child care centers, 168 child care providers, and 672 children from these centers to one of two groups (standard Go NAPSACC or Go NAPSACC enhanced) for a 12 month trial (6 months provider weight loss; 6 months no contact follow-up). The specific aims are to 1) improve dietary quality and physical activity behaviors of 2-5-year-old children. 2) improve weight and weight related behaviors (dietary intake and physical activity) of child care providers, and 3) improve the nutrition and physical activity environments at child care centers. Participants randomized to standard Go NAPSACC will receive support for center wide changes focusing on engaging center directors and orienting them to Go NAPSACC, given access to interactive online tools that guide change, and providing ongoing support as they work to adopt evidence-based healthy weight practices. Participants randomized to Go NAPSACC enhanced will receive the traditional Go NAPSACC program (previously described); in addition, child care providers will receive a weight management intervention. The weight management intervention will be guided by social cognitive theory and integrate techniques known to be most effective for changing diet and physical activity behaviors, including intention formation, goal setting (≥5% weight loss at 6 mos. and no regain at 12 mos.), self-monitoring (diet, physical activity, weight), and feedback. Participants will receive a progressive physical activity program. The physical activity program (walking, jogging, biking, etc.) will be progressive and prescribed at a moderate intensity as recommended the "Physical Activity Guidelines for Americans" of 150 min/wk. Starting active minutes goal will be based on self-reported current activity levels: 0 min/wk = 10 min/day goal; 1-59 min/wk = 15/min/day goal, >60 min/wk = 20 min/day goal. The reduced energy diet will follow the Stop Light Diet approach which categorizes foods by energy content: green (low energy: consume freely), yellow (moderate energy: consume in moderation) and red (high energy: consume sparingly). Starting weight will be used to suggest tailored red food limits: Weight Loss - <250lbs = 3; 250 - <300 = 4; >300 = 5. Weight Maintenance - <250 = 4; 250 - <300 = 5; >300 = 6. The stop light diet approach is suitable for all participants (including for whom weight loss may not be recommended [e.g., BMI <25 kg/m2] as it does not specifically prescribe a calorie deficit but focuses on improvement of diet quality.The effectiveness of the intervention will be evaluated by comparing differences between the Go NAPSACC enhanced and standard Go NAPSACC control groups in child's physical activity and diet quality at 6 mos. (primary outcomes). Primary and secondary aims will be analyzed using maximum likelihood methods. Multi-level linear mixed models with repeated measures will be used to estimate change at 6 and 12 mos. and to test for statistical differences across groups in changes over time. Models will include random effect for cluster to account for covariance between participants within the same center as well as fixed effects for time, trial arm, time*arm interaction. To further explore the effect of the intervention, these analyses will be followed by sensitivity analyses that adjust for baseline variables distributed differently between intervention groups and examine completers only. Secondary outcomes will also be examined as longitudinal covariates and asses their association with longitudinal measures of primary outcomes, controlling for treatment, at 6 and 12 months.
- Conditions
- Obesity
- Being tested
- Go NAPSACC Enhanced, Go NAPSACC
- Keywords
- child care centers, child care provider health, nutrition, physical activity, body weight, behavior change
- Medical subject headings
- Obesity, Motor Activity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go NAPSACC EnhancedBehavioural
Also called Go NAPSACC Cares
Centers will receive the Go NAPSACC program as well as an online weight management intervention that focuses on personal weight management strategies. Participants will have access to materials that will support their adoption of evidence-based strategies for their weight management or loss goal. Behavior change strategies used are meant to increase intervention adherence and improve weight loss.
Go NAPSACCBehavioural
Go NAPSACC is an online evidence-based behavioral intervention that supports centers as they adopt center-wide healthy weight practices. It anticipates producing change in the child care environment through fostering best practices in center provisions, practices, policies, and professional development around child nutrition and physical activity and in turn foster healthier habits in the children in their care.
| Study group | Role | What they receive |
|---|---|---|
| Go NAPSACC | Active comparator | Centers randomized to Go NAPSACC will receive the traditional Go NAPSACC program. This will include the center director leading the Go NAPSACC effort with support from a Go NAPSACC Implementation advisor. The advisor will orient each center to Go NAPSACC and its online tools and check in monthly with directors as they work through 2 cycles of Go NAPSACC over 6 months. Centers will take self-assessments on nutrition and physical activity, choose 6 goals (3 from each), create action plans, and take action to achieve their chosen goals. Receives: Behavioral: Go NAPSACC |
| Go NAPSACC Enhanced | Experimental | Centers randomized to Go NAPSACC Enhanced will receive the traditional Go NAPSACC program as described in the Active Comparator arm. Additionally, child care providers will simultaneously receive a weight management program, Go NAPSACC Cares over 6 months. The health educator will orient providers with the website and its tools and resources. Providers will take a self-assessment and choose a goal of weight maintenance or weight loss. They will go through 18 lessons with accompanying resources. Within the website they will self-monitor their weight, physical activity, and red foods (diet quality). Providers will receive daily tips, weekly reminders via text message or email, and tailored weekly feedback based on their weight management goals and progress. Receives: Behavioral: Go NAPSACC Enhanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Children's Diet Quality at Child Care from Baseline to 6 months
Dietary intake of food consumed by 2-5-year-old children will be assessed via the Diet Observation in Child Care (DOCC) by a trained and certified data collector in the 2-5-year old classroom. Dietary intake data will be used to calculate Healthy Eating Index 2015 (HEI2015) scores to produce an estimate of children's diet quality. Scores range from 0-100, where scores closer to 100 indicate higher diet quality.
Measured: Baseline and 6 months post-intervention
Change in Children's Non-sedentary Time at Child Care from Baseline to 6 months
Physical activity of children 2-5-years old will be assessed by a GT3X+ accelerometer. Children are fitted on the first day of data collection and wear the accelerometer on their non-dominant wrist for 24 hours per day over 7 consecutive days. Cut-points developed for preschool-aged children will be applied to children's accelerometer data to calculate minutes spent in different levels of physical activity (total non-sedentary, sedentary, light, moderate, and vigorous). Non-sedentary time (light, moderate, and vigorous combined) is the primary outcome for this study.
Measured: Baseline and 6 months post-intervention
Secondary outcomes (7)
Change in Children's Diet Quality at Child Care from 6 to 12 months
Dietary intake of food consumed by 2-5-year-old children will be assessed via the Diet Observation in Child Care (DOCC) by a trained and certified data collector in the 2-5-year old classroom. Dietary intake data will be used to calculate Healthy Eating Index 2015 (HEI2015) scores to produce an estimate of children's diet quality. Scores range from 0-100, where scores closer to 100 indicate higher diet quality.
Measured: 6 months post-intervention and 12 months post-intervention
Change in Children's Non-sedentary Time at Child Care from 6 to 12 Months
Physical activity of children 2-5-years old will be assessed by a GT3X+ accelerometer. Children are fitted on the first day of data collection and wear the accelerometer on their non-dominant wrist for 24 hours per day over 7 consecutive days. Cut-points developed for preschool-aged children will be applied to children's accelerometer data to calculate minutes spent in different levels of physical activity (total non-sedentary, sedentary, light, moderate, and vigorous). Non-sedentary time (light, moderate, and vigorous combined) is the physical activity outcome.
Measured: 6 months post-intervention and 12 months post-intervention
Change in Child Care Providers Diet Quality
Dietary intake of food consumed by child care providers will be assessed by self-report through the Automated Self-Administered Dietary Assessment Tool (ASA24) over 2 weekdays and 1 weekend day. Dietary intake data will be used to calculate Healthy Eating Index 2015 (HEI2015) scores to produce an estimate of children's diet quality. Scores range from 0-100, where scores closer to 100 indicate higher diet quality. Assessed at baseline and post-intervention at months 6 and 12.
Measured: Baseline through 12 months post intervention
Change in Child Care Providers Physical Activity
Physical activity of child care providers will be assessed by a GT3X+ accelerometer. Child care providers are fitted on the first day of data collection and wear the accelerometer on their non-dominant wrist for 24 hours per day over 7 consecutive days. Cut-points developed for adults will be applied to child care providers accelerometer data to calculate minutes spent in different levels of physical activity (sedentary, light, moderate, and vigorous). Assessed at baseline and post-intervention at months 6 and 12.
Measured: Baseline through 12 months post intervention
Change in Child Care Providers weight
Anthropometrics will be collected in the morning of the onsite visit while participants are in light clothing with shoes removed. Weight will be measured to the nearest 0.1 kg using a Seca digital scale (calibrated quarterly; seca, Chino, CA). Assessed at baseline and post-intervention at months 6 and 12.
Measured: Baseline through 12 months post intervention
Change in Nutrition Environment Score
Each center's nutrition environment will be assessed by trained and certified data collectors who spend two days at the center in a participating classroom using the Environment and Policy Assessment and Observation (EPAO) and Document Review. An overall nutrition environment score will be derived with scores ranging from 0-21, where higher scores indicate better (more supportive) nutrition and physical activity environments. Assessed at baseline and post-intervention at months 6 and 12.
Measured: Baseline through 12 months post intervention
Change in Physical Activity Environment Score
Each center's physical environment will be assessed by trained and certified data collectors who spend two days at the center in a participating classroom using the Environment and Policy Assessment and Observation (EPAO) and Document Review. An overall physical activity environment score will be derived with scores ranging from 0-36, where higher scores indicate better (more supportive) nutrition and physical activity environments. Assessed at baseline and post-intervention at months 6 and 12.
Measured: Baseline through 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start18 Jan 2023
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
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 ObesityStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 924 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Willis, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656807
- Sponsor's protocol ID
- 22-0257
- Other IDs
- R01DK128174
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina-Chapel Hill (UNC-CH).
Publications
Willis EA, Burney R, Hales D, Ilugbusi LO, Tate DF, Nezami B, Clarke EC, Moore RH, Mathews E, Thompson M, Beckelheimer B, Ward DS. "My wellbeing-their wellbeing "- An eHealth intervention for managing obesity in early care and education: Protocol for the Go NAPSACC Cares cluster randomized control trial. PLoS One. 2023 Jul 7;18(7):e0286912. doi: 10.1371/journal.pone.0286912. eCollection 2023.
PubMed 37418363
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Weight-their Weight: eHealth Intervention for Managing Obesity in Child Care Settings
- ClinicalTrials.gov ID
- NCT05656807
- Acronym / sponsor ID
- 22-0257
- Conditions
- Obesity
- Keywords
- child care centers, child care provider health, nutrition, physical activity, body weight, behavior change
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 924 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Dec 2022 (actual)
- 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 goal of this 12-month cluster clinical trial is to evaluate if improving child care providers' health behaviors using an online provider weight management program elicits meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment.
The study sample will include 84 child care centers. Including: 84 center directors, 168 2-5-year-old classroom teachers, 672 2-5-year old children.
Some centers will do only the online Nutrition and Physical Activity Self-Assessment for Child Care (Go NAPSACC) program. This program works with child care center directors to make changes to their center around child nutrition and physical activity to foster healthier habits for the children enrolled in their care. Other centers will do Go NAPSACC Enhanced. This will include center directors doing Go NAPSACC and 2-5 year old teachers doing an online weight management program with support.
Researchers will compare centers in Go NAPSACC with centers in Go NAPSACC Enhanced to see if there are greater improvements in children's diet quality and physical activity, as well as the nutrition and physical activity environment of centers in the Go NAPSACC Enhanced group. Additionally, they will see if there are greater improvements in teachers' weight, diet quality, and physical activity in centers using Go NAPSACC Enhanced.
Detailed description
This study is a two-group clustered randomized trial to evaluate if improving child care providers' health behaviors elicit meaningful change in dietary and physical activity behaviors in 2-5-year-old preschool children in their care and the child care environment. The investigators will randomize (by center, 1:1 ratio) 84 child care centers, 168 child care providers, and 672 children from these centers to one of two groups (standard Go NAPSACC or Go NAPSACC enhanced) for a 12 month trial (6 months provider weight loss; 6 months no contact follow-up). The specific aims are to 1) improve dietary quality and physical activity behaviors of 2-5-year-old children. 2) improve weight and weight related behaviors (dietary intake and physical activity) of child care providers, and 3) improve the nutrition and physical activity environments at child care centers. Participants randomized to standard Go NAPSACC will receive support for center wide changes focusing on engaging center directors and orienting them to Go NAPSACC, given access to interactive online tools that guide change, and providing ongoing support as they work to adopt evidence-based healthy weight practices. Participants randomized to Go NAPSACC enhanced will receive the traditional Go NAPSACC program (previously described); in addition, child care providers will receive a weight management intervention. The weight management intervention will be guided by social cognitive theory and integrate techniques known to be most effective for changing diet and physical activity behaviors, including intention formation, goal setting (≥5% weight loss at 6 mos. and no regain at 12 mos.), self-monitoring (diet, physical activity, weight), and feedback. Participants will receive a progressive physical activity program. The physical activity program (walking, jogging, biking, etc.) will be progressive and prescribed at a moderate intensity as recommended the "Physical Activity Guidelines for Americans" of 150 min/wk. Starting active minutes goal will be based on self-reported current activity levels: 0 min/wk = 10 min/day goal; 1-59 min/wk = 15/min/day goal, >60 min/wk = 20 min/day goal. The reduced energy diet will follow the Stop Light Diet approach which categorizes foods by energy content: green (low energy: consume freely), yellow (moderate energy: consume in moderation) and red (high energy: consume sparingly). Starting weight will be used to suggest tailored red food limits: Weight Loss - <250lbs = 3; 250 - <300 = 4; >300 = 5. Weight Maintenance - <250 = 4; 250 - <300 = 5; >300 = 6. The stop light diet approach is suitable for all participants (including for whom weight loss may not be recommended [e.g., BMI <25 kg/m2] as it does not specifically prescribe a calorie deficit but focuses on improvement of diet quality.The effectiveness of the intervention will be evaluated by comparing differences between the Go NAPSACC enhanced and standard Go NAPSACC control groups in child's physical activity and diet quality at 6 mos. (primary outcomes). Primary and secondary aims will be analyzed using maximum likelihood methods. Multi-level linear mixed models with repeated measures will be used to estimate change at 6 and 12 mos. and to test for statistical differences across groups in changes over time. Models will include random effect for cluster to account for covariance between participants within the same center as well as fixed effects for time, trial arm, time*arm interaction. To further explore the effect of the intervention, these analyses will be followed by sensitivity analyses that adjust for baseline variables distributed differently between intervention groups and examine completers only. Secondary outcomes will also be examined as longitudinal covariates and asses their association with longitudinal measures of primary outcomes, controlling for treatment, at 6 and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Go NAPSACC | Active comparator | Behavioral: Go NAPSACCCenters randomized to Go NAPSACC will receive the traditional Go NAPSACC program. This will include the center director leading the Go NAPSACC effort with support from a Go NAPSACC Implementation advisor. The advisor will orient each center to Go NAPSACC and its online tools and check in monthly with directors as they work through 2 cycles of Go NAPSACC over 6 months. Centers will take self-assessments on nutrition and physical activity, choose 6 goals (3 from each), create action plans, and take action to achieve their chosen goals. |
| Go NAPSACC Enhanced | Experimental | Behavioral: Go NAPSACC EnhancedCenters randomized to Go NAPSACC Enhanced will receive the traditional Go NAPSACC program as described in the Active Comparator arm. Additionally, child care providers will simultaneously receive a weight management program, Go NAPSACC Cares over 6 months. The health educator will orient providers with the website and its tools and resources. Providers will take a self-assessment and choose a goal of weight maintenance or weight loss. They will go through 18 lessons with accompanying resources. Within the website they will self-monitor their weight, physical activity, and red foods (diet quality). Providers will receive daily tips, weekly reminders via text message or email, and tailored weekly feedback based on their weight management goals and progress. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Be open year-round
- Licensed with no plans to close in the next 2 years
- Been in operation for at least 1 year
- Have at least two classrooms serving children 2-5 years-old
- Serve at least lunch to the 2-5-year old children
Key exclusion criteria (2 listed)
- Serve only non-English speaking families
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 NAPSACC EnhancedAlso: Go NAPSACC CaresCenters will receive the Go NAPSACC program as well as an online weight management intervention that focuses on personal weight management strategies. Participants will have access to materials that will support their adoption of evidence-based strategies for their weight management or loss goal. Behavior change strategies used are meant to increase intervention adherence and improve weight loss. | Behavioural | Go NAPSACC Enhanced |
| Go NAPSACCGo NAPSACC is an online evidence-based behavioral intervention that supports centers as they adopt center-wide healthy weight practices. It anticipates producing change in the child care environment through fostering best practices in center provisions, practices, policies, and professional development around child nutrition and physical activity and in turn foster healthier habits in the children in their care. | Behavioural | Go NAPSACC |
Primary outcome
Change in Children's Diet Quality at Child Care from Baseline to 6 months
Time frame: Baseline and 6 months post-intervention
Dietary intake of food consumed by 2-5-year-old children will be assessed via the Diet Observation in Child Care (DOCC) by a trained and certified data collector in the 2-5-year old classroom. Dietary intake data will be used to calculate Healthy Eating Index 2015 (HEI2015) scores to produce an estimate of children's diet quality. Scores range from 0-100, where scores closer to 100 indicate higher diet quality.
Change in Children's Non-sedentary Time at Child Care from Baseline to 6 months
Time frame: Baseline and 6 months post-intervention
Physical activity of children 2-5-years old will be assessed by a GT3X+ accelerometer. Children are fitted on the first day of data collection and wear the accelerometer on their non-dominant wrist for 24 hours per day over 7 consecutive days. Cut-points developed for preschool-aged children will be applied to children's accelerometer data to calculate minutes spent in different levels of physical activity (total non-sedentary, sedentary, light, moderate, and vigorous). Non-sedentary time (light, moderate, and vigorous combined) is the primary outcome for this study.
7 secondary outcomes
Change in Children's Diet Quality at Child Care from 6 to 12 months
Time frame: 6 months post-intervention and 12 months post-intervention
Change in Children's Non-sedentary Time at Child Care from 6 to 12 Months
Time frame: 6 months post-intervention and 12 months post-intervention
Change in Child Care Providers Diet Quality
Time frame: Baseline through 12 months post intervention
Change in Child Care Providers Physical Activity
Time frame: Baseline through 12 months post intervention
Change in Child Care Providers weight
Time frame: Baseline through 12 months post intervention
Change in Nutrition Environment Score
Time frame: Baseline through 12 months post intervention
Change in Physical Activity Environment Score
Time frame: Baseline through 12 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 37418363Willis EA, Burney R, Hales D, Ilugbusi LO, Tate DF, Nezami B, Clarke EC, Moore RH, Mathews E, Thompson M, Beckelheimer B, Ward DS. "My wellbeing-their wellbeing "- An eHealth intervention for managing obesity in early care and education: Protocol for the Go NAPSACC Cares cluster randomized control trial. PLoS One. 2023 Jul 7;18(7):e0286912. doi: 10.1371/journal.pone.0286912. eCollection 2023.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina-Chapel Hill (UNC-CH).
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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.
Erik Willis, PhD 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 NAPSACC Enhanced and Go NAPSACC in people with Obesity, run by UNC Lineberger Comprehensive Cancer Center 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 17 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 Children's Diet Quality at Child Care from Baseline to 6 months (time frame: Baseline and 6 months post-intervention). The study lists 2 primary outcomes in all. 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 NCT05656807, 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 9 Sep 2026.