Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/04/2015
Date assigned
24/04/2015
Last edited
30/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the USA, First Lady Michelle Obama started a nationwide child care initiative called ‘Let's Move!’ which aims to improve nutrition and physical activity practices in child care centres to promote healthy childhood weight. The Healthy Apple (HA) Program, developed by various organisations based in San Francisco, provides services specifically designed to support ‘Let's Move!’ and aims to tackle childhood obesity in children aged 0-5. The San Francisco Department of Public Health (SFDH) has an existing Child Care Health Program (CCHP) which promotes routine health screening of children and improvement of school health programmes. CCHP centres mainly help children from low income families. The aim of this study is to see whether child care centres using the HA programme alongside usual CCHP services could improve child care centre nutrition and physical activity practices better than centres using CCHP services alone. The study is also comparing changes in children’s body mass index (BMI) during the course of a year in HA+CCHP centres and CCHP-alone centres.

Who can participate?
Children and staff of child care centres serviced by the SFDH CCHP.

What does the study involve?
Participating child care staff complete HA self-assessment questionnaires at the start and end of the trial. Staff receive help to implement positive changes to their centre’s health programme, based on their own suggestions. Trained HA health workers visit centres and make note of their health and nutrition resources, such as play equipment and healthy food options. Staff are also interviewed about their centre’s practices. Health workers also record the height and weight of each child to calculate their BMI.

What are the possible benefits and risks of participating?
Participating child care centres may show greater implementation of best practices for health and nutrition. Children who attend participating centres may show improved weight gain/loss as a result of better understanding of healthy eating choices and lifestyle. There are no risks associated with taking part in this study.

Where is the study run from?
San Francisco Department of Public Health, Child Care Health Program (USA)

When is the study starting and how long is it expected to run for?
September 2011 to June 2014

Who is funding the study?
San Francisco Department of Public Health (USA)

Who is the main contact?
Dr J Stookey
jodi.stookey@sfdph.org

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jodi Stookey

ORCID ID

http://orcid.org/0000-0001-9604-2392

Contact details

SFDPH MCAH
30 Van Ness
Ste 210
San Francisco
94102
United States of America
+1 (0)415 575 5651
jodi.stookey@sfdph.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Healthy Apple Program pilot intervention for child care centers in San Francisco to improve their nutrition and physical activity practices and mean weight change for enrolled children ages 2 to 4 over 6 months

Acronym

HAP pilot

Study hypothesis

Child care centers that participate in the Healthy Apple (HA) program increase the number of nutrition and physical activity best practices and improve the mean weight change of enrolled children over 6 months relative to child care centers that do not participate in the HA program.

Ethics approval

UCSF Human Research Protection Program Committee on Human Research, 13/06/2015, IRB #: 15-16534, Reference #: 138098

Study design

Cluster randomised controlled trial.

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Nutrition and physical activity practices of child care centers and weight change of children enrolled in child care centers.

Intervention

1. Intervention group receives usual San Francisco Dept of Health Child Care Health Program (SFDH CCHP) services plus additional invitation to:
1.1. Complete a Healthy Apple provider self-assessment
1.2. Set goals for improving nutrition and/or physical activity practices
1.3. Receive Healthy Apple technical assistance materials
1.4. Attend Healthy Apple nutrition and physical activity workshops
1.5. Receive a Healthy Apple award recognizing nutrition and/or physical activity best practices
2. Control group receives usual SFDH CCHP services, which include health worker assessment of child care center nutrition and physical activity resources and BMI screening for all enrolled children.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Number of nutrition and physical activity best practices implemented

Secondary outcome measures

Child care center mean 6 month change in BMI percentile

Overall trial start date

01/09/2011

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All children enrolled at the participating child care centers serviced by the SFDH CCHP are eligible to take part, and for services and follow-up.

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

38 child care centers/~900 children ages 2-4

Participant exclusion criteria

Child care centers not served by the SFDPH CCHP.

Recruitment start date

01/09/2011

Recruitment end date

30/06/2014

Locations

Countries of recruitment

United States of America

Trial participating centre

San Francisco Department of Public Health, Child Care Health Program
30 Van Ness, Ste 260
San Francisco
94117
United States of America

Sponsor information

Organisation

San Francisco Department of Public Health (USA)

Sponsor details

30 Van Ness
San Francisco
94102
United States of America

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

San Francisco Department of Public Health (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the effect of Healthy Apple program participation on change in nutrition and physical activity best practices and 6-month change in BMI percentile. We expect to submit a manuscript for publication in Fall 2015.

Intention to publish date

01/01/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/03/2016: Ethics approval information added.