Childhood ObesityNCT02799433
Evaluation of the Healthy Apple Program in San Francisco
A study testing Usual services + HAP and Usual services in people with Childhood Obesity, run by San Francisco Department of Public Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Usual services + HAP and Usual services
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,493 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2015
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child care center received nutrition screening services from the SFDPH Child Care Health Program in 2011-2012.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Department of Public Health
San Francisco, California, 94102
About this study
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
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.
Read the detailed 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.
- Conditions
- Childhood Obesity
- Being tested
- Usual services + HAP, Usual services
- Keywords
- Water, Physical activity, Child care, Weight change
- Medical subject headings
- Pediatric Obesity, Motor Activity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual services + HAPBehavioural
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 servicesBehavioural
Control condition
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual services + HAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI percentile change
Annually, child BMI percentile is measured in Fall and about 6 months later in Spring.
Measured: Fall to Spring (about 6 months)
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startSep 2011
- Primary completionJun 2015
- Study completionJun 2015
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 Childhood ObesityStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 3,493 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Department of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jodi Stookey, San Francisco Department of Public Health
- Investigators
- Jodi Stookey, PhD, Principal investigator, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799433
- Sponsor's protocol ID
- CTG HAP20112015
- Status last verified
- Jun 2016
- First submitted
- 10 Jun 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data used for this analysis are public health program screening data.
Publications
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.
PubMed 17572971Alkon 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.
PubMed 24580983
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02799433
- Acronym / sponsor ID
- CTG HAP20112015
- Conditions
- Childhood Obesity
- Keywords
- Water, Physical activity, Child care, Weight change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,493 participants (actual)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Study start
- Sep 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Jun 2016 (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 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Services | Active comparator | Behavioral: Usual servicesThis 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. |
| Usual services + HAP | Experimental | Behavioral: Usual services + HAPThis 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. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child care center received nutrition screening services from the SFDPH Child Care Health Program in 2011-2012.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Usual services + HAPThe 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. | Behavioural | Usual services + HAP |
| Usual servicesControl condition | Behavioural | Usual Services |
Primary outcome
BMI percentile change
Time frame: Fall to Spring (about 6 months)
Annually, child BMI percentile is measured in Fall and about 6 months later in Spring.
1 secondary outcome
Incident overweight or obesity
Time frame: 6 months
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 14 Jun 2016.
- Background: PubMed 17572971Ammerman 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.
- Background: PubMed 24580983Alkon 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.
- Website for the Let's Move! Child Care initiativeLink provided by the sponsor.
- Individual participant dataSharing planned: No. The data used for this analysis are public health program screening data.
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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.
Jodi Stookey, PhD principal investigator
San Francisco Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual services + HAP and Usual services in people with Childhood Obesity, run by San Francisco Department of Public Health at 1 site 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 1 inclusion and 4 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 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
BMI percentile change (time frame: Fall to Spring (about 6 months)). 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 NCT02799433, 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 14 Jun 2016; AzTrials last refreshed its copy on 6 Nov 2026.