Overweight and ObesityPhase 1NCT03321071
Healthy Summer Learners
A Phase 1 study testing Healthy Summer Learners and 21st Century Summer Learning Center in people with Overweight and Obesity and Academic Acheivement, run by University of South Carolina at 1 site in United States.
Trial summary
Summer vacation represents a "window of vulnerability" where dramatic declines in both health and academics occur for elementary age children. Currently, there are no summer programs that incorporate curriculum addressing both unhealthy weight gains and academic achievement simultaneously. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Overweight and Obesity, Academic Acheivement
- What is being tested?
- Healthy Summer Learners and 21st Century Summer Learning Center
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- MAP scores are norm referenced based on typical grade level scores. Students that have scored between the 25th and 75th percentile will be eligible to participate in the study.
Who cannot join
- children with severe intellectual or physical disabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29205
About this study
Official title: Interventions to Promote Healthy Lifestyle and Academic Performance in Children During the Summer Months.
Summer vacation represents a "window of vulnerability" where dramatic declines in both health and academics occur for elementary age children. Currently, there are no summer programs that incorporate curriculum addressing both unhealthy weight gains and academic achievement simultaneously. This work represents an important step towards addressing important public health goals - obesity and learning - through a comprehensive program delivered during a timeframe - summer vacation - where substantial and long-lasting negative effects occur.
Read the detailed description
Summer vacation represents an important time away from the school setting for a majority of children attending public school in the US. This break is characterized by large amounts of free time and involvement in a wide variety of formal and informal activities, time spent with friends and family, and travel. Yet for many children, particularly those from low-income households, summer vacation represents a "window of vulnerability" in which dramatic declines in both health and academics occur. During the summer months (typically 3 months) children gain a larger amount of body weight compared to the amount of weight gained over the school year, and weight gain during summer reverses weight losses achieved during school. For academics, it is well established that children from low-income households experience greater declines in reading and math during the summer than their middle-to-upper income peers. Numerous programs that address these issues currently exist (e.g., summer school, summer weight loss or fitness programs). However, these programs are designed and delivered at the expense of the promotion or prevention of the other - academic focus without health or health focus without academics. Our long-term goal is to develop summer programming for widespread dissemination that addresses both lifestyle behaviors (i.e., physical activity and nutrition) and academic performance. The objective of the proposed study is to establish the effectiveness of an innovative "Healthy Summer Learners" (HSL) program for low-income, minority children. The rationale for the proposed research is that no summer programs incorporate curriculum that addresses both unhealthy weight gains and academic achievement simultaneously. This study seeks to fill this void by testing a prototype learning and health-oriented summer program focused on promoting physical activity and nutrition, along with content that provides quality learning experiences to develop reading and math skills. To accomplish this objective, this study will evaluate over 2 summers the effectiveness of a 6-week Healthy Summer Learners program delivered within a Boys \& Girls Club summer camp using a randomized design in a sample of rising 2nd, 3rd, and 4th graders. The aims of the study are Aim 1: Evaluate the impact of Healthy Summer Learners on children's weight gain and academic performance from beginning (end of Spring school year) to the end of summer (beginning of Fall school year), and Aim 2: Evaluate the feasibility and acceptability of Healthy Summer Learners to children, parents, and program staff.
- Conditions
- Overweight and Obesity, Academic Acheivement
- Being tested
- Healthy Summer Learners, 21st Century Summer Learning Center
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Summer LearnersBehavioural
Physical Activity Component. The physical activity component of Healthy Summer Learners is designed to engage children in moderate-to-vigorous physical activity (MVPA) for at least 50% of the time. With 3 hours each day dedicated to physical activity, this translates into children accumulating 90 minutes of MVPA daily. This is 30 minutes above the 60 minutes of MVPA each day recommended by the Physical Activity Guidelines for Americans.
Nutrition Component. The nutrition component of Healthy Summer Learners is designed to provide healthy snacks and meals and nutrition education via standardized pre-existing curricula.
Food/Beverage Guidelines. Meals will follow the USDA Nutrition Standards for the National School Lunch and School Breakfast Programs.
Academic Component. The academic component will consist of existing, effective academic programs focused on Math and Reading.
21st Century Summer Learning CenterBehavioural
Children in this condition will attend a 21st Century Summer Learning Program.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Summer Learners | Experimental | Similar to typical summer day camp procedures, students attending Healthy Summer Learners will be dropped-off and picked-up at camp. The physical activity component of the program was designed with the expertise and input from B\&G Club youth program staff. The academic component was informed by school district personnel. The program was also designed to be analogous to typical summer day camp program in terms of operating weeks (10 weeks) length of program day (i.e., 8am-5pm), and program component time blocks (~45min-1hr time blocks). Receives: Behavioral: Healthy Summer Learners |
| 21st Century Learning Center | Active comparator | Children in this condition will attend a 21st Century Summer Learning Program. Receives: Behavioral: 21st Century Summer Learning Center |
| Passive control | No intervention | Children in this condition will not attend a summer program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI) Z-score
Measure Description: Centers for Disease Control age and sex-specific Body Mass Index z-scores. A z-score of 0 represents the population mean. Higher or lower z-scores could represent better or worse outcomes as too low could be underweight and too high could indicate overweight or obesity.
Children above the 85th percentile are considered overweight while children above the 95th percentile are considered obese
Measured: Body mass index will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
Change in Measures of Academic Progress Reading Scores
Measure Description: Created by the Northwest Evaluation Association (www.nwea.org), MAP results are widely accepted and used extensively in school-aged children. Scores are reported using the Rasch Unit Scale, a curriculum scale developed using Item Response Theory that estimates student achievement. The Rasch Unit Scale ranges from 140-300 and are norm referenced based on grade. Higher scores indicate better reading profeciency.
Measured: MAP reading scores will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
Secondary outcomes (8)
Average Minutes Per Day Spent in Moderate to Vigorous Physical Activity During the Summer on Days Attending a Program and Not Attending a Program
Moderate to vigorous physical activity will be collected via a wrist placed Fitbit. Negative numbers mean the behavior decreased on days attending while positive numbers indicate the behavior increased on days attending. No change is indicated for the passive control as they did not attend a program. Passive control never attended a structured summer program thus no change can be calculated.
Measured: Moderate to vigorous physical activity will be collected daily from baseline to 12 weeks
Average Minutes Per Day Spent in Sedentary Behavior During the Summer on Days Attending a Program and Not Attending a Program
Sedentary time will be collected via a wrist placed Fitbit. Negative numbers mean the behavior decreased on days attending while positive numbers indicate the behavior increased on days attending. No change is indicated for the passive control as they did not attend a program. Passive control never attended a structured summer program thus no change can be calculated.
Measured: Sedentary time will be collected daily from baseline to 12 weeks
Average Minutes Per Day Screen Time During the Summer on Days Attending a Program and Not Attending a Program
Screen time will be collected via parent proxy report during the summer. Passive control never attended a structured summer program thus no change can be calculated.
Measured: Screen time will be collected twice weekly from baseline to 12 weeks
Average Number of Healthy Foods Consumed/Day on Days Attending a Program and Not Attending a Program
Diet will be collected via food frequency questionnaires and the number of healthy and unhealthy foods consumed will be calculated. Negative numbers mean the number of healthy foods consumed decreased on days attending while positive numbers indicate the number of healthy foods consumed increased on days attending. No change is indicated for the passive control as they did not attend a program. Passive control never attended a structured summer program thus no change can be calculated.
Measured: Diet will be collected twice weekly from baseline to 12 weeks
Average Minutes Per Day of Sleep During the Summer on Days Attending a Program and Not Attending a Program
Sleep time will be collected via a wrist placed Fitbit. Negative numbers mean the behavior decreased on days attending while positive numbers indicate the behavior increased on days attending. No change is indicated for the passive control as they did not attend a program.
Measured: Sleep will be collected daily from baseline to 12 weeks
Average Minutes Per Day Shift in Sleep Onset During the Summer on Days Attending a Program and Not Attending a Program.
Sleep onset will be collected via a wrist placed Fitbit. Negative numbers indicate sleep onset was earlier on days attending while positive numbers indicate sleep onset was later on days attending. No change is indicated for the passive control as they did not attend a program.
Measured: Sleep onset will be collected daily from baseline to 12 weeks
Average Minutes Per Day Shift in Sleep Offset During the Summer on Days Attending a Program and Not Attending a Program
Sleep offset will be collected via a wrist-placed Fitbit. Negative numbers mean sleep offset was earlier on days attending while positive numbers indicate sleep offset was later on days attending. No change is indicated for the passive control as they did not attend a program.
Measured: Sleep offset will be collected daily from baseline to 12 weeks
Average Minutes Per Day Shift in Sleep Midpoint During the Summer on Days Attending a Program and Not Attending a Program
Sleep midpoint will be collected via a wrist placed Fitbit. Negative numbers mean midpoint was earlier on days attending while positive numbers indicate midpoint was later on days attending. No change is indicated for the passive control as they did not attend a program.
Measured: Sleep midpoint will be collected daily from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 May 2018
- Primary completion1 May 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Glenn Weaver, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321071
- Sponsor's protocol ID
- Pro00065094
- Status last verified
- Jan 2024
- First submitted
- 25 Aug 2017
- Last updated
- 5 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD data.
Publications
von Klinggraeff L, Dugger R, Brazendale K, Hunt ET, Moore JB, Turner-McGrievy G, Vogler K, Beets MW, Armstrong B, Weaver RG. Healthy Summer Learners: An explanatory mixed methods study and process evaluation. Eval Program Plann. 2022 Jun;92:102070. doi: 10.1016/j.evalprogplan.2022.102070. Epub 2022 Mar 17.
PubMed 35339766Dugger R, Brazendale K, Hunt ET, Moore JB, Turner-McGrievy G, Vogler K, Beets MW, Armstrong B, Weaver RG. The impact of summer programming on the obesogenic behaviors of children: behavioral outcomes from a quasi-experimental pilot trial. Pilot Feasibility Stud. 2020 May 28;6:78. doi: 10.1186/s40814-020-00617-x. eCollection 2020.
PubMed 32514369
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Promote Healthy Lifestyle and Academic Performance in Children During the Summer Months.
- ClinicalTrials.gov ID
- NCT03321071
- Acronym / sponsor ID
- Pro00065094
- Conditions
- Overweight and Obesity, Academic Acheivement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Posted 5 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Summer vacation represents a "window of vulnerability" where dramatic declines in both health and academics occur for elementary age children. Currently, there are no summer programs that incorporate curriculum addressing both unhealthy weight gains and academic achievement simultaneously. This work represents an important step towards addressing important public health goals - obesity and learning - through a comprehensive program delivered during a timeframe - summer vacation - where substantial and long-lasting negative effects occur.
Detailed description
Summer vacation represents an important time away from the school setting for a majority of children attending public school in the US. This break is characterized by large amounts of free time and involvement in a wide variety of formal and informal activities, time spent with friends and family, and travel. Yet for many children, particularly those from low-income households, summer vacation represents a "window of vulnerability" in which dramatic declines in both health and academics occur. During the summer months (typically 3 months) children gain a larger amount of body weight compared to the amount of weight gained over the school year, and weight gain during summer reverses weight losses achieved during school. For academics, it is well established that children from low-income households experience greater declines in reading and math during the summer than their middle-to-upper income peers. Numerous programs that address these issues currently exist (e.g., summer school, summer weight loss or fitness programs). However, these programs are designed and delivered at the expense of the promotion or prevention of the other - academic focus without health or health focus without academics. Our long-term goal is to develop summer programming for widespread dissemination that addresses both lifestyle behaviors (i.e., physical activity and nutrition) and academic performance. The objective of the proposed study is to establish the effectiveness of an innovative "Healthy Summer Learners" (HSL) program for low-income, minority children. The rationale for the proposed research is that no summer programs incorporate curriculum that addresses both unhealthy weight gains and academic achievement simultaneously. This study seeks to fill this void by testing a prototype learning and health-oriented summer program focused on promoting physical activity and nutrition, along with content that provides quality learning experiences to develop reading and math skills. To accomplish this objective, this study will evaluate over 2 summers the effectiveness of a 6-week Healthy Summer Learners program delivered within a Boys \& Girls Club summer camp using a randomized design in a sample of rising 2nd, 3rd, and 4th graders. The aims of the study are Aim 1: Evaluate the impact of Healthy Summer Learners on children's weight gain and academic performance from beginning (end of Spring school year) to the end of summer (beginning of Fall school year), and Aim 2: Evaluate the feasibility and acceptability of Healthy Summer Learners to children, parents, and program staff.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Summer Learners | Experimental | Behavioral: Healthy Summer LearnersSimilar to typical summer day camp procedures, students attending Healthy Summer Learners will be dropped-off and picked-up at camp. The physical activity component of the program was designed with the expertise and input from B\&G Club youth program staff. The academic component was informed by school district personnel. The program was also designed to be analogous to typical summer day camp program in terms of operating weeks (10 weeks) length of program day (i.e., 8am-5pm), and program component time blocks (~45min-1hr time blocks). |
| 21st Century Learning Center | Active comparator | Behavioral: 21st Century Summer Learning CenterChildren in this condition will attend a 21st Century Summer Learning Program. |
| Passive control | No intervention | –Children in this condition will not attend a summer program. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- MAP scores are norm referenced based on typical grade level scores. Students that have scored between the 25th and 75th percentile will be eligible to participate in the study.
Key exclusion criteria (1 listed)
- children with severe intellectual or physical disabilities
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 |
|---|---|---|
| Healthy Summer LearnersPhysical Activity Component. The physical activity component of Healthy Summer Learners is designed to engage children in moderate-to-vigorous physical activity (MVPA) for at least 50% of the time. With 3 hours each day dedicated to physical activity, this translates into children accumulating 90 minutes of MVPA daily. This is 30 minutes above the 60 minutes of MVPA each day recommended by the Physical Activity Guidelines for Americans. Nutrition Component. The nutrition component of Healthy Summer Learners is designed to provide healthy snacks and meals and nutrition education via standardized pre-existing curricula. Food/Beverage Guidelines. Meals will follow the USDA Nutrition Standards for the National School Lunch and School Breakfast Programs. Academic Component. The academic component will consist of existing, effective academic programs focused on Math and Reading. | Behavioural | Healthy Summer Learners |
| 21st Century Summer Learning CenterChildren in this condition will attend a 21st Century Summer Learning Program. | Behavioural | 21st Century Learning Center |
Primary outcome
Change in Body Mass Index (BMI) Z-score
Time frame: Body mass index will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
Measure Description: Centers for Disease Control age and sex-specific Body Mass Index z-scores. A z-score of 0 represents the population mean. Higher or lower z-scores could represent better or worse outcomes as too low could be underweight and too high could indicate overweight or obesity. Children above the 85th percentile are considered overweight while children above the 95th percentile are considered obese
Change in Measures of Academic Progress Reading Scores
Time frame: MAP reading scores will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL
Measure Description: Created by the Northwest Evaluation Association (www.nwea.org), MAP results are widely accepted and used extensively in school-aged children. Scores are reported using the Rasch Unit Scale, a curriculum scale developed using Item Response Theory that estimates student achievement. The Rasch Unit Scale ranges from 140-300 and are norm referenced based on grade. Higher scores indicate better reading profeciency.
8 secondary outcomes
Average Minutes Per Day Spent in Moderate to Vigorous Physical Activity During the Summer on Days Attending a Program and Not Attending a Program
Time frame: Moderate to vigorous physical activity will be collected daily from baseline to 12 weeks
Average Minutes Per Day Spent in Sedentary Behavior During the Summer on Days Attending a Program and Not Attending a Program
Time frame: Sedentary time will be collected daily from baseline to 12 weeks
Average Minutes Per Day Screen Time During the Summer on Days Attending a Program and Not Attending a Program
Time frame: Screen time will be collected twice weekly from baseline to 12 weeks
Average Number of Healthy Foods Consumed/Day on Days Attending a Program and Not Attending a Program
Time frame: Diet will be collected twice weekly from baseline to 12 weeks
Average Minutes Per Day of Sleep During the Summer on Days Attending a Program and Not Attending a Program
Time frame: Sleep will be collected daily from baseline to 12 weeks
Average Minutes Per Day Shift in Sleep Onset During the Summer on Days Attending a Program and Not Attending a Program.
Time frame: Sleep onset will be collected daily from baseline to 12 weeks
Average Minutes Per Day Shift in Sleep Offset During the Summer on Days Attending a Program and Not Attending a Program
Time frame: Sleep offset will be collected daily from baseline to 12 weeks
Average Minutes Per Day Shift in Sleep Midpoint During the Summer on Days Attending a Program and Not Attending a Program
Time frame: Sleep midpoint will be collected daily from baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35339766von Klinggraeff L, Dugger R, Brazendale K, Hunt ET, Moore JB, Turner-McGrievy G, Vogler K, Beets MW, Armstrong B, Weaver RG. Healthy Summer Learners: An explanatory mixed methods study and process evaluation. Eval Program Plann. 2022 Jun;92:102070. doi: 10.1016/j.evalprogplan.2022.102070. Epub 2022 Mar 17.
- Derived from this study: PubMed 32514369Dugger R, Brazendale K, Hunt ET, Moore JB, Turner-McGrievy G, Vogler K, Beets MW, Armstrong B, Weaver RG. The impact of summer programming on the obesogenic behaviors of children: behavioral outcomes from a quasi-experimental pilot trial. Pilot Feasibility Stud. 2020 May 28;6:78. doi: 10.1186/s40814-020-00617-x. eCollection 2020.
- Individual participant dataSharing planned: No. We will not share IPD 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.
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 Phase 1 study testing Healthy Summer Learners and 21st Century Summer Learning Center in people with Overweight and Obesity and Academic Acheivement, run by University of South Carolina 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 1 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 5 Jul 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Body Mass Index (BMI) Z-score (time frame: Body mass index will be collected in the spring academic semester up to 6 weeks prior to attending HSL and the fall academic semester up to 6 weeks after attending HSL). The study lists 2 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 NCT03321071, 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 5 Jul 2024.