ObesityNCT01890681
Baby Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) Intervention Study
A study testing Baby NAP SACC and Back to Sleep in people with Obesity, run by Johns Hopkins University at 3 sites in United States.
Trial summary
This study will evaluate the efficacy of a six-month-long intervention in improving the nutrition and physical activity environments of child care centers serving racially and ethnically diverse children from birth to two years of age and the family home. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Baby NAP SACC and Back to Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 960 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2013to 31 Dec 2018
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- licensed child care centers in North Carolina (NC) serving children birth - 2
- within 120 mile radius of Duke University
- children must be from participating center and 3-18 months of age at baseline
- read/speak English
- adult teachers from infant/toddler classrooms within participating centers
- adult parents of infant/toddlers within participating centers
Who cannot join
- child care centers outside of 120 mile radius of Duke University
- children younger than 3 months or over 18 months of age
- parents with children who intend to leave the participating center in < 12 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21218
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27516
Duke University Medical Center, Department of Community and Family Medicine
Durham, North Carolina, 27710
About this study
Official title: Preventing Obesity in Infants and Toddlers in Child Care
This study will evaluate the efficacy of a six-month-long intervention in improving the nutrition and physical activity environments of child care centers serving racially and ethnically diverse children from birth to two years of age and the family home. The focus of the intervention will be on center policies, provider and parent practices, and children's home environments that influence dietary intake and physical activity. Outcomes for this study include child dietary intake, physical activity, and two adiposity measures: weight-for-length and skinfold thicknesses. Child care centers and children's home environments will also be measured to evaluate how well they support healthy behaviors.
- Conditions
- Obesity
- Being tested
- Baby NAP SACC, Back to Sleep
- Keywords
- childhood obesity, child care, infant, toddler
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby NAP SACCBehavioural
Back to SleepBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Back to Sleep | Active comparator | The Back to Sleep arm will encourage safe sleep practices to reduce the risk of Sudden Infant Death Syndrome (SIDS) in child care and at home. This include:
1. center and family self-assessment,
2. center intervention materials delivered several times over the 6-month period, and;
3. parent handouts
After the intervention period, comparator centers will receive an abbreviated version of the Baby NAP SACC intervention. Receives: Behavioral: Back to Sleep |
| Baby NAP SACC | Experimental | The intervention will include four complementary and mutually reinforcing components:
1. center and family self-assessment;
2. targeted technical assistance by Baby NAP SACC consultant for providers and parents;
3. training workshops for child care providers; and
4. parent outreach and support. Receives: Behavioral: Baby NAP SACC |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in weight-for-length z-score
Measured: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
change in skinfold thickness
Measured: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
Secondary outcomes (3)
change in child physical activity via accelerometer
Measured: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
change in child dietary intake
Measured: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
change in child care policies and practices
Measured: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study start1 Aug 2013
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Benjamin Neelon, PhD, RD, MPH, Principal investigator, Johns Hopkins UniversityTruls Ostbye, MD/PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890681
- Sponsor's protocol ID
- Pro00039195
- Other IDs
- R01DK093838
- Status last verified
- Jan 2019
- First submitted
- 27 Jun 2013
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjamin Neelon SE, Ostbye T, Hales D, Vaughn A, Ward DS. Preventing childhood obesity in early care and education settings: lessons from two intervention studies. Child Care Health Dev. 2016 May;42(3):351-8. doi: 10.1111/cch.12329. Epub 2016 Mar 14.
PubMed 26987658Hewitt L, Benjamin-Neelon SE, Carson V, Stanley RM, Janssen I, Okely AD. Child care centre adherence to infant physical activity and screen time recommendations in Australia, Canada and the United States: An observational study. Infant Behav Dev. 2018 Feb;50:88-97. doi: 10.1016/j.infbeh.2017.11.008. Epub 2017 Dec 7.
PubMed 29223777
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Obesity in Infants and Toddlers in Child Care
- ClinicalTrials.gov ID
- NCT01890681
- Acronym / sponsor ID
- Pro00039195
- Conditions
- Obesity
- Keywords
- childhood obesity, child care, infant, toddler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 2 Jul 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.
This study will evaluate the efficacy of a six-month-long intervention in improving the nutrition and physical activity environments of child care centers serving racially and ethnically diverse children from birth to two years of age and the family home. The focus of the intervention will be on center policies, provider and parent practices, and children's home environments that influence dietary intake and physical activity. Outcomes for this study include child dietary intake, physical activity, and two adiposity measures: weight-for-length and skinfold thicknesses. Child care centers and children's home environments will also be measured to evaluate how well they support healthy behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Back to Sleep | Active comparator | Behavioral: Back to SleepThe Back to Sleep arm will encourage safe sleep practices to reduce the risk of Sudden Infant Death Syndrome (SIDS) in child care and at home. This include: 1. center and family self-assessment, 2. center intervention materials delivered several times over the 6-month period, and; 3. parent handouts After the intervention period, comparator centers will receive an abbreviated version of the Baby NAP SACC intervention. |
| Baby NAP SACC | Experimental | Behavioral: Baby NAP SACCThe intervention will include four complementary and mutually reinforcing components: 1. center and family self-assessment; 2. targeted technical assistance by Baby NAP SACC consultant for providers and parents; 3. training workshops for child care providers; and 4. parent outreach and support. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- licensed child care centers in North Carolina (NC) serving children birth - 2
- within 120 mile radius of Duke University
- children must be from participating center and 3-18 months of age at baseline
- read/speak English
- adult teachers from infant/toddler classrooms within participating centers
Key exclusion criteria (3 listed)
- child care centers outside of 120 mile radius of Duke University
- children younger than 3 months or over 18 months of age
- parents with children who intend to leave the participating center in < 12 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 |
|---|---|---|
| Baby NAP SACC | Behavioural | Baby NAP SACC |
| Back to Sleep | Behavioural | Back to Sleep |
Primary outcome
change in weight-for-length z-score
Time frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
change in skinfold thickness
Time frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
3 secondary outcomes
change in child physical activity via accelerometer
Time frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
change in child dietary intake
Time frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
change in child care policies and practices
Time frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
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 29 Jan 2019.
- Results publication: PubMed 26987658Benjamin Neelon SE, Ostbye T, Hales D, Vaughn A, Ward DS. Preventing childhood obesity in early care and education settings: lessons from two intervention studies. Child Care Health Dev. 2016 May;42(3):351-8. doi: 10.1111/cch.12329. Epub 2016 Mar 14.
- Results publication: PubMed 29223777Hewitt L, Benjamin-Neelon SE, Carson V, Stanley RM, Janssen I, Okely AD. Child care centre adherence to infant physical activity and screen time recommendations in Australia, Canada and the United States: An observational study. Infant Behav Dev. 2018 Feb;50:88-97. doi: 10.1016/j.infbeh.2017.11.008. Epub 2017 Dec 7.
- 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.
Sara Benjamin Neelon, PhD, RD, MPH principal investigator
Johns Hopkins University
Truls Ostbye, MD/PhD principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby NAP SACC and Back to Sleep in people with Obesity, run by Johns Hopkins University at 3 sites 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 6 inclusion and 3 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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 weight-for-length z-score (time frame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)). 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 NCT01890681, which also lists 2 linked publications.
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 29 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.