Evaluation of the Healthy Apple Program in San Francisco

Childhood Obesity Clinical Trial

Official title:

Evaluation of the Healthy Apple Program to Improve Nutrition and Physical Activity Practices and Child Weight Change in Child Care Centers in San Francisco

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799433
• Other study ID #: CTG HAP20112015
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: June 10, 2016
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: San Francisco Department of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

In the USA, First Lady Michelle Obama started a nationwide child care initiative called 'Let's Move! Child Care' which aims to improve nutrition and physical activity practices in child care centers to promote healthy weight for children ages 0-5y.

The San Francisco Child Care Wellness Collaborative, including the San Francisco Department of Public Health (SFDPH) and SF Children's Council, developed a citywide Healthy Apple Program (HAP) to support local implementation of the Let's Move! initiative.

The San Francisco Department of Public Health (SFDH) has an existing Child Care Health Program (CCHP) which provides nurse consultation and health education materials for child care centers and annual health screenings for children.

The aim of this analysis is to see whether child care centers offered the HAP in addition to usual CCHP services can improve child care center nutrition and physical activity practices and child weight change better than usual CCHP services alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3493
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Usual services + HAP
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
Control condition

Locations

Country	Name	City	State
United States	San Francisco Department of Public Health	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
San Francisco Department of Public Health

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of best practices	Child care center best practices, including use of physical activity curricula or pitchers of drinking water, and staff practice of joining in active play with children.	6 months	No
Primary	BMI percentile change	Annually, child BMI percentile is measured in Fall and about 6 months later in Spring.	Fall to Spring (about 6 months)	No
Secondary	Incident overweight or obesity	New cases of overweight or obesity that developed between the Fall and Spring screening during the school year. % of children who are normal weight in Fall who become overweight or obese by Spring.	6 months	No

External Links

•   Website for the Let's Move! Child Care initiative