NCT02799433

Brief Summary

This randomized controlled trial uses administrative public health screening data to test whether the Healthy Apple program (HAP), designed to support local implementation of national Let's Move! Child Care guidelines in San Francisco (SF), improves child care center nutrition and physical activity practices and child weight change.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,493

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

3.8 years

First QC Date

June 10, 2016

Last Update Submit

June 10, 2016

Conditions

Keywords

WaterPhysical activityChild careWeight change

Outcome Measures

Primary Outcomes (1)

  • BMI percentile change

    Annually, child BMI percentile is measured in Fall and about 6 months later in Spring.

    Fall to Spring (about 6 months)

Secondary Outcomes (1)

  • Incident overweight or obesity

    6 months

Other Outcomes (1)

  • Number of best practices

    6 months

Study Arms (2)

Usual Services

ACTIVE COMPARATOR

This group of child care centers receives standard services from the San Francisco Department of Public Health Child Care Health Program. CCHP offers services to child care centers annually. The standard services include nurse consultation, health education, monitoring of nutrition and physical activity resource need, vision, hearing, oral health, and height and weight screenings.

Behavioral: Usual services

Usual services + HAP

EXPERIMENTAL

This group of child care centers receives all the standard services plus invitation to participate in the voluntary Healthy Apple Program (HAP). The Healthy Apple program involves child care provider self-assessment, followed by an iterative process of goal setting, technical assistance/training, and re-assessment.

Behavioral: Usual services + HAP

Interventions

The HAP process includes child care center providers completing a self-assessment(s), setting improvement goals, receiving technical assistance materials, attending topic-specific workshops, improving best practices, re-self-assessment and qualification for a HAP award.

Usual services + HAP
Usual servicesBEHAVIORAL

Control condition

Usual Services

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child care center received nutrition screening services from the SFDPH Child Care Health Program in 2011-2012.

You may not qualify if:

  • Child care center declines CCHP services in 2012-2015.
  • Child care center is ineligible for CCHP services (based on funding source)
  • Child care center is closed or not serving children
  • Child or family decline the voluntary services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Department of Public Health

San Francisco, California, 94102, United States

Location

Related Publications (2)

  • Ammerman AS, Ward DS, Benjamin SE, Ball SC, Sommers JK, Molloy M, Dodds JM. An intervention to promote healthy weight: Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) theory and design. Prev Chronic Dis. 2007 Jul;4(3):A67. Epub 2007 Jun 15.

    PMID: 17572971BACKGROUND
  • 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.

    PMID: 24580983BACKGROUND

Related Links

MeSH Terms

Conditions

Pediatric ObesityMotor ActivityBody Weight Changes

Interventions

retinoic acid receptor beta

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jodi Stookey, PhD

    San Francisco Department of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Epidemiologist

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 14, 2016

Study Start

September 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 14, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

The data used for this analysis are public health program screening data.

Locations