Pediatric ObesityPHASTNCT03118635
Effect of the Enhanced Summer Food Service Program on Schoolchildren
A study testing Intervention in people with Pediatric Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
Convergent findings from several studies document that children, especially those who are already overweight or obese or from racial / ethnic minority groups, are at risk for accelerated weight gain during the summer months. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2016to 1 Sep 2016
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Low-income (defined as qualifying for free or reduced-price meals as part of the National School Lunch Program)
- Ages 6-12 years
- Ability of child to speak, read and write English (for purposes of assessment and intervention)
- Parent/guardian involvement
- Agreement to study participation
- Intent to participate in the SFSP in the upcoming summer
Who cannot join
- Medical condition that would interfere with participation in physical activity
- Enrolled in a camp or other physical activity based summer program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effect of the Enhanced Summer Food Service Program on the Health of Schoolchildren
Convergent findings from several studies document that children, especially those who are already overweight or obese or from racial / ethnic minority groups, are at risk for accelerated weight gain during the summer months. Therefore, this project is comprised of three separate community-based interventions designed to increase access to healthy meals and physical activity opportunities to minimize excess summer weight gain in elementary school children from a diverse, low-income Rhode Island community. Specifically, we will complete a quasi-experimental study in which we will design and deliver a physical activity intervention in conjunction with the Summer Food Service Program (SFSP) to 50 children living in a low-income, urban community. We anticipate that the addition of physical activity programming to the SFSP, a federal program funded by the USDA which reimburses states for serving lunch meals to children during the summer in communities where at least 50% of students are eligible for free or reduced-price school meals, will increase both the acceptability and effectiveness of the SFSP and affect 1) physical activity levels, 2) sedentary behavior, and 3) diet quality. The primary outcome (change in BMI z-score) will be compared between the 50 kids enrolled in the active intervention and 50 children enrolled in the control condition, both recruited from the same community.
- Conditions
- Pediatric Obesity
- Being tested
- Intervention
- Keywords
- Summer, Diet, Physical Activity, Sedentary behavior, Low-income
- Medical subject headings
- Pediatric Obesity, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Physical activity programming in accordance with the SPARK - After School curriculum as well as engaging activities provided by local community partners. The intervention proceeded the SFSP lunch meal service, so that children received approximately three hours of physical activity programming daily.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Daily, four-hour physical activity intervention Receives: Behavioral: Intervention |
| Control | No intervention | No treatment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI z-score over the summer
BMI was measured at the baseline visit (early June 2016) and three months later at the end of the summer (late August, 2016). Outcome of interest was change (BMIz at f/u - BMIz at baseline)
Measured: Three months (summer)
Secondary outcomes (3)
Physical Activity
Activity was measured using a wrist-worn ActiGraph for 7-days. Outcome of interest was minutes of bout-related moderate to vigorous physical activity
Measured: Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention
Sedentary Behavior
Activity was measured using a wrist-worn ActiGraph for 7-days. Outcome of interest was percent of total wear time spent sedentary (<100 counts/minute)
Measured: Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention
Energy intake
Reported calorie intake from three, non-consecutive 24-hour diet recalls
Measured: Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start15 Jun 2016
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118635
- Sponsor's protocol ID
- GFT640211
- Acronym
- PHAST
- Status last verified
- Mar 2017
- First submitted
- 4 Apr 2017
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evans EW, Bond DS, Pierre DF, Howie WC, Wing RR, Jelalian E. Promoting health and activity in the summer trial: Implementation and outcomes of a pilot study. Prev Med Rep. 2018 Feb 16;10:87-92. doi: 10.1016/j.pmedr.2018.02.008. eCollection 2018 Jun.
PubMed 29868357
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of the Enhanced Summer Food Service Program on the Health of Schoolchildren
- ClinicalTrials.gov ID
- NCT03118635
- Acronym / sponsor ID
- PHAST / GFT640211
- Conditions
- Pediatric Obesity
- Keywords
- Summer, Diet, Physical Activity, Sedentary behavior, Low-income
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
Convergent findings from several studies document that children, especially those who are already overweight or obese or from racial / ethnic minority groups, are at risk for accelerated weight gain during the summer months. Therefore, this project is comprised of three separate community-based interventions designed to increase access to healthy meals and physical activity opportunities to minimize excess summer weight gain in elementary school children from a diverse, low-income Rhode Island community. Specifically, we will complete a quasi-experimental study in which we will design and deliver a physical activity intervention in conjunction with the Summer Food Service Program (SFSP) to 50 children living in a low-income, urban community. We anticipate that the addition of physical activity programming to the SFSP, a federal program funded by the USDA which reimburses states for serving lunch meals to children during the summer in communities where at least 50% of students are eligible for free or reduced-price school meals, will increase both the acceptability and effectiveness of the SFSP and affect 1) physical activity levels, 2) sedentary behavior, and 3) diet quality. The primary outcome (change in BMI z-score) will be compared between the 50 kids enrolled in the active intervention and 50 children enrolled in the control condition, both recruited from the same community.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionDaily, four-hour physical activity intervention |
| Control | No intervention | –No treatment control |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Low-income (defined as qualifying for free or reduced-price meals as part of the National School Lunch Program)
- Ages 6-12 years
- Ability of child to speak, read and write English (for purposes of assessment and intervention)
- Parent/guardian involvement
- Agreement to study participation
Key exclusion criteria (2 listed)
- Medical condition that would interfere with participation in physical activity
- Enrolled in a camp or other physical activity based summer program.
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 |
|---|---|---|
| InterventionPhysical activity programming in accordance with the SPARK - After School curriculum as well as engaging activities provided by local community partners. The intervention proceeded the SFSP lunch meal service, so that children received approximately three hours of physical activity programming daily. | Behavioural | Intervention |
Primary outcome
Change in BMI z-score over the summer
Time frame: Three months (summer)
BMI was measured at the baseline visit (early June 2016) and three months later at the end of the summer (late August, 2016). Outcome of interest was change (BMIz at f/u - BMIz at baseline)
3 secondary outcomes
Physical Activity
Time frame: Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention
Sedentary Behavior
Time frame: Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention
Energy intake
Time frame: Cross-sectional measure taken for 7 days during the window of weeks 4-6 of the 8 week intervention
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 4 Sep 2019.
- Derived from this study: PubMed 29868357Evans EW, Bond DS, Pierre DF, Howie WC, Wing RR, Jelalian E. Promoting health and activity in the summer trial: Implementation and outcomes of a pilot study. Prev Med Rep. 2018 Feb 16;10:87-92. doi: 10.1016/j.pmedr.2018.02.008. eCollection 2018 Jun.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Pediatric Obesity, run by The Miriam Hospital 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 6 inclusion and 2 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 4 Sep 2019. 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?
Change in BMI z-score over the summer (time frame: Three months (summer)). 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 NCT03118635, which also lists 1 linked publication.
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 4 Sep 2019.