Clinical trial NCT01890681: Baby Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) Intervention Study
Official title: Preventing Obesity in Infants and Toddlers in Child Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: childhood obesity
child care
infant
toddler
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-07-02
Enrollment: 960
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: change in weight-for-length z-score
timeFrame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
measure: change in skinfold thickness
timeFrame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
Secondary outcomes:
measure: change in child physical activity via accelerometer
timeFrame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
measure: change in child dietary intake
timeFrame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
measure: change in child care policies and practices
timeFrame: pre to post-intervention (from baseline to post-intervention; approximately 8 months later)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center, Department of Community and Family Medicine
state: North Carolina
Study officials:
affiliation: Johns Hopkins University
name: Sara Benjamin Neelon, PhD, RD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Truls Ostbye, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Hewitt 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.