Childhood Obesity PreventionNCT04085965
Testing the Feasibility and Preliminary Effect of Summer Camp
A study testing Boys and Girls Club summer day camp in people with Childhood Obesity Prevention, run by The Miriam Hospital at 1 site in United States.
Trial summary
This pilot randomized controlled trial was designed to assess the feasibility and preliminary efficacy of randomizing children, ages 6-12 years from two low-income communities in Rhode Island, to attend a summer day camp (CAMP) or to experience summer as usual (SAU). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity Prevention
- What is being tested?
- Boys and Girls Club summer day camp
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2017to 22 Aug 2018
- 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
- Qualify for free or reduced-price meals at school
- Speak English (for purposes of camp participation)
- Agree, along with their parent(s), to randomization.
Who cannot join
- A medical condition that interferes with participation in physical activity
- Enrollment in summer programming (camp, summer school, etc) for more than one week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Feasibility and Preliminary Effect of Summer Day Camp on Excess Summer Weight Gain in Children From Low-income Communities
This pilot randomized controlled trial was designed to assess the feasibility and preliminary efficacy of randomizing children, ages 6-12 years from two low-income communities in Rhode Island, to attend a summer day camp (CAMP) or to experience summer as usual (SAU). Children randomized to CAMP attended a Boys and Girls Club summer day camp for 8-weeks in summer 2017 or 2018. As part of the consent process, children randomized to SAU agreed to experience an unstructured summer (i.e. not enroll in more than one week of summer camp, summer school or other structured summer programming). Primary feasibility outcomes included retention, engagement and completion of midsummer measures. Secondary outcomes, change in BMIz (a proxy for excess summer weight gain), physical activity engagement, sedentary behavior, and diet (energy intake and diet quality), were collected by blinded research staff at the end of the school year, midsummer and the end of the summer.
- Conditions
- Childhood Obesity Prevention
- Being tested
- Boys and Girls Club summer day camp
- Keywords
- Summer Camp, Child overweight / obesity, Diet, Physical Activity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boys and Girls Club summer day campBehavioural
Daily camp activities included sports, games, obstacle courses, swimming and boating, summer learning and arts and crafts. Lunch was served daily via the USDA's Summer Food Service Program.
| Study group | Role | What they receive |
|---|---|---|
| CAMP | Experimental | Children randomized to CAMP were enrolled in the Boys and Girls Club Camp in one of two low-income Rhode Island communities in summer 2017 or 2018 for 7-weeks in 2017 and 8-weeks in 2018 due to a delayed end to the 2017 school year (i.e. snow days). Camp was offered daily from 8:30 to 4:30. Receives: Behavioral: Boys and Girls Club summer day camp |
| Summer As Usual | No intervention | Children randomized to the SAU group were asked to experience an unstructured summer as otherwise planned by their parent / guardian. They agreed to not attend structured summer programming (i.e. camp, summer school, or day care) for more than one week over the summer so as to provide an inactive control group for comparison to those in CAMP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Number of participants who completed both baseline and end of summer assessments
Measured: Baseline to end of summer; 8 weeks
Camp Attendance
Number of days children attended the Boys and Girls Club Camp
Measured: 8 weeks
Participation in Summer Activities
Number of days children attended camp, summer school, or day care over the summer
Measured: 8 weeks
Completion of study measures
Number of participants who completed three 24-hour diet recalls and/or 7-days of actigraphy at baseline and mid-summer assessment visits
Measured: Baseline (May / June); Midsummer (mid-July)
Secondary outcomes (5)
Excess summer weight gain
Change in BMIz
Measured: Baseline to end of summer; 8 weeks
Physical Activity
Change in minutes of moderate to vigorous physical activity (MVPA) as measured by ActiGraph accelerometer
Measured: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Sedentary Behavior
Change in percent time spent sedentary as measured by ActiGraph accelerometer
Measured: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Energy Intake
Change in total energy intake as measured from 3 non-consecutive 24-hour diet recalls
Measured: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Diet Quality
Change in Diet Quality as measured by the HEI-2015 from three non-consecutive 24-hour diet recalls
Measured: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start17 May 2017
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
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 Childhood Obesity PreventionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hassenfeld Child Health Innovation Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085965
- Sponsor's protocol ID
- 710-9073
- Status last verified
- Aug 2019
- First submitted
- 3 Sep 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evans EW, Wing RR, Pierre DF, Howie WC, Brinker M, Jelalian E. Testing the effect of summer camp on excess summer weight gain in youth from low-income households: a randomized controlled trial. BMC Public Health. 2020 Nov 17;20(1):1732. doi: 10.1186/s12889-020-09806-y.
PubMed 33203385
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility and Preliminary Effect of Summer Day Camp on Excess Summer Weight Gain in Children From Low-income Communities
- ClinicalTrials.gov ID
- NCT04085965
- Acronym / sponsor ID
- 710-9073
- Conditions
- Childhood Obesity Prevention
- Keywords
- Summer Camp, Child overweight / obesity, Diet, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Hassenfeld Child Health Innovation Institute
- Study start
- 17 May 2017 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 11 Sep 2019 (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.
This pilot randomized controlled trial was designed to assess the feasibility and preliminary efficacy of randomizing children, ages 6-12 years from two low-income communities in Rhode Island, to attend a summer day camp (CAMP) or to experience summer as usual (SAU). Children randomized to CAMP attended a Boys and Girls Club summer day camp for 8-weeks in summer 2017 or 2018. As part of the consent process, children randomized to SAU agreed to experience an unstructured summer (i.e. not enroll in more than one week of summer camp, summer school or other structured summer programming). Primary feasibility outcomes included retention, engagement and completion of midsummer measures. Secondary outcomes, change in BMIz (a proxy for excess summer weight gain), physical activity engagement, sedentary behavior, and diet (energy intake and diet quality), were collected by blinded research staff at the end of the school year, midsummer and the end of the summer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAMP | Experimental | Behavioral: Boys and Girls Club summer day campChildren randomized to CAMP were enrolled in the Boys and Girls Club Camp in one of two low-income Rhode Island communities in summer 2017 or 2018 for 7-weeks in 2017 and 8-weeks in 2018 due to a delayed end to the 2017 school year (i.e. snow days). Camp was offered daily from 8:30 to 4:30. |
| Summer As Usual | No intervention | –Children randomized to the SAU group were asked to experience an unstructured summer as otherwise planned by their parent / guardian. They agreed to not attend structured summer programming (i.e. camp, summer school, or day care) for more than one week over the summer so as to provide an inactive control group for comparison to those in CAMP. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Qualify for free or reduced-price meals at school
- Speak English (for purposes of camp participation)
- Agree, along with their parent(s), to randomization.
Key exclusion criteria (2 listed)
- A medical condition that interferes with participation in physical activity
- Enrollment in summer programming (camp, summer school, etc) for more than one week
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 |
|---|---|---|
| Boys and Girls Club summer day campDaily camp activities included sports, games, obstacle courses, swimming and boating, summer learning and arts and crafts. Lunch was served daily via the USDA's Summer Food Service Program. | Behavioural | CAMP |
Primary outcome
Retention
Time frame: Baseline to end of summer; 8 weeks
Number of participants who completed both baseline and end of summer assessments
Camp Attendance
Time frame: 8 weeks
Number of days children attended the Boys and Girls Club Camp
Participation in Summer Activities
Time frame: 8 weeks
Number of days children attended camp, summer school, or day care over the summer
Completion of study measures
Time frame: Baseline (May / June); Midsummer (mid-July)
Number of participants who completed three 24-hour diet recalls and/or 7-days of actigraphy at baseline and mid-summer assessment visits
5 secondary outcomes
Excess summer weight gain
Time frame: Baseline to end of summer; 8 weeks
Physical Activity
Time frame: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Sedentary Behavior
Time frame: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Energy Intake
Time frame: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Diet Quality
Time frame: 4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
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 11 Sep 2019.
- Derived from this study: PubMed 33203385Evans EW, Wing RR, Pierre DF, Howie WC, Brinker M, Jelalian E. Testing the effect of summer camp on excess summer weight gain in youth from low-income households: a randomized controlled trial. BMC Public Health. 2020 Nov 17;20(1):1732. doi: 10.1186/s12889-020-09806-y.
- 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 Boys and Girls Club summer day camp in people with Childhood Obesity Prevention, 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 3 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 11 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?
Retention (time frame: Baseline to end of summer; 8 weeks). The study lists 4 primary outcomes in all. 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 NCT04085965, 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 11 Sep 2019.