Childhood ObesityYMCA-PANNCT01107678
YMCA-Physical Activity and Nutrition
A study testing Healthy Snacks and Organized Physical Activity in people with Childhood Obesity, run by University of Kansas at 1 site in United States.
Trial summary
There is an epidemic rise in the number of overweight and obese children. Overweight and obesity in children tracks into adulthood and carries elevated risk of chronic diseases such as seen with the metabolic syndrome (i.e., elevated glucose, hypertension, etc.). Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Healthy Snacks and Organized Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 966 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2013
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- kindergarten through second grade age;
Who cannot join
- no BMI requirements but must meet age requirements and be available throughout the duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, 66045
About this study
Official title: The YMCA After School Program of Physical Activity and Nutrition
There is an epidemic rise in the number of overweight and obese children. Overweight and obesity in children tracks into adulthood and carries elevated risk of chronic diseases such as seen with the metabolic syndrome (i.e., elevated glucose, hypertension, etc.). Low levels of PA and poor nutrition seem to be tightly linked to the increase in overweight and obesity. A minimal intervention that targets simple strategies for both sides of the energy balance equation may diminish overweight and obesity. Increasing moderate to vigorous physical activity and improving nutrition through snacks is a feasible, low cost strategy and can be disseminated nationally through the YMCA, if successful. Specifically, we expect that children receiving YMCA PAN will show smaller changes in BMI after 3 years of the intervention when compared to children not receiving YMCA PAN (i.e. standard, existing YMCA After School Program or "YMCA standard care").
Read the detailed description
Our primary outcome measurement is body mass index (BMI) as this is now recommended by major health organizations as the preferred measure for the determination of obesity. All children at YMCA After School Programs will receive either YMCA-PAN or YMCA standard care; however, we will only follow children in grades kindergarten through second grade (K-2). For children in grades K-2, we will determine if 3 years of increased physical activity and snacks lower in energy and fat and higher in nutrient density will diminish gains in BMI. We have specifically targeted an increase of moderate to vigorous physical activity (MVPA) by 225 minutes per week that is delivered in YMCA-PAN as this is a compromise between the recommendations suggested by Healthy People 2010 and the Institute of Medicine (IOM) and is administratively feasible within the existing YMCA After School Programs. YMCA-PAN would exceed the Healthy People 2010 guidelines and would provide the majority of PA for the IOM guidelines. Children would satisfy the IOM guidelines with just 15 additional minutes of MVPA accrued throughout the day in physical education class or free play. Finally, YMCA PAN would provide opportunity for PA at the very time the guidelines call "most critical:" the hours between 3 and 6pm when children have finished the school day and frequently are sedentary. For the nutritional component, we are targeting snacks, as snacks are part of the YMCA after school programs, snacks contribute significantly to 24 hour energy intake, children are increasingly in control of the snacks they consume, and we have previously diminished 24 hour energy intake and fat intake using snacks in elementary school children.
We will provide this intervention using regular YMCA staff and use the regular time periods for PA that exist in the YMCA after school programs. We will also use the regular YMCA staff to provide snacks. Specifically, we expect that children receiving YMCA-PAN will show smaller changes in BMI after 3 years of the intervention when compared to children not receiving YMCA-PAN (i.e. standard, existing YMCA after school program or "YMCA standard care").
- Conditions
- Childhood Obesity
- Being tested
- Healthy Snacks and Organized Physical Activity
- Keywords
- YMCA; Preventative child obesity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Snacks and Organized Physical ActivityOther
Also called YMCA PAN, YMCA Standard Care
Children in the intervention group will receive healthy snacks, smaller portion sizes and participate in organized physical activity on a daily bais
| Study group | Role | What they receive |
|---|---|---|
| YMCA PAN | Experimental | YMCA PAN (Physical activity and nutrition)- Consists of organized physical activity and controlled serving sizes of healthy low fat snacks Receives: Other: Healthy Snacks and Organized Physical Activity |
| YMCA Standard CAre | Experimental | YMCA standard care - Follow the standard care of the YMCA after school Y-Care program for physical activity and nutrition Receives: Other: Healthy Snacks and Organized Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Body weight and height will be measured in order to calculate BMI
Measured: 3 years
Secondary outcomes (2)
Daily physical activity levels
Length of time and intensity of the program's physical activity sessions will be measured by visual observation on a daily basis
Measured: Daily
Daily energy intake
Energy intake of the snacks served during the program will be measured by visual observation in both the intervention and control schools on a daily basis
Measured: Daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJul 2007
- Primary completionMay 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 966 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Donnelly, University of Kansas
- Investigators
- Joseph E Donnelly, EdD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107678
- Sponsor's protocol ID
- HSCL16198
- Other IDs
- R01DK074909
- Acronym
- YMCA-PAN
- Status last verified
- Jan 2014
- First submitted
- 26 Mar 2010
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The YMCA After School Program of Physical Activity and Nutrition
- ClinicalTrials.gov ID
- NCT01107678
- Acronym / sponsor ID
- YMCA-PAN / HSCL16198
- Conditions
- Childhood Obesity
- Keywords
- YMCA; Preventative child obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 966 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2007
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Apr 2010 (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.
There is an epidemic rise in the number of overweight and obese children. Overweight and obesity in children tracks into adulthood and carries elevated risk of chronic diseases such as seen with the metabolic syndrome (i.e., elevated glucose, hypertension, etc.). Low levels of PA and poor nutrition seem to be tightly linked to the increase in overweight and obesity. A minimal intervention that targets simple strategies for both sides of the energy balance equation may diminish overweight and obesity. Increasing moderate to vigorous physical activity and improving nutrition through snacks is a feasible, low cost strategy and can be disseminated nationally through the YMCA, if successful. Specifically, we expect that children receiving YMCA PAN will show smaller changes in BMI after 3 years of the intervention when compared to children not receiving YMCA PAN (i.e. standard, existing YMCA After School Program or "YMCA standard care").
Detailed description
Our primary outcome measurement is body mass index (BMI) as this is now recommended by major health organizations as the preferred measure for the determination of obesity. All children at YMCA After School Programs will receive either YMCA-PAN or YMCA standard care; however, we will only follow children in grades kindergarten through second grade (K-2). For children in grades K-2, we will determine if 3 years of increased physical activity and snacks lower in energy and fat and higher in nutrient density will diminish gains in BMI. We have specifically targeted an increase of moderate to vigorous physical activity (MVPA) by 225 minutes per week that is delivered in YMCA-PAN as this is a compromise between the recommendations suggested by Healthy People 2010 and the Institute of Medicine (IOM) and is administratively feasible within the existing YMCA After School Programs. YMCA-PAN would exceed the Healthy People 2010 guidelines and would provide the majority of PA for the IOM guidelines. Children would satisfy the IOM guidelines with just 15 additional minutes of MVPA accrued throughout the day in physical education class or free play. Finally, YMCA PAN would provide opportunity for PA at the very time the guidelines call "most critical:" the hours between 3 and 6pm when children have finished the school day and frequently are sedentary. For the nutritional component, we are targeting snacks, as snacks are part of the YMCA after school programs, snacks contribute significantly to 24 hour energy intake, children are increasingly in control of the snacks they consume, and we have previously diminished 24 hour energy intake and fat intake using snacks in elementary school children.
We will provide this intervention using regular YMCA staff and use the regular time periods for PA that exist in the YMCA after school programs. We will also use the regular YMCA staff to provide snacks. Specifically, we expect that children receiving YMCA-PAN will show smaller changes in BMI after 3 years of the intervention when compared to children not receiving YMCA-PAN (i.e. standard, existing YMCA after school program or "YMCA standard care").
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YMCA PAN | Experimental | Other: Healthy Snacks and Organized Physical ActivityYMCA PAN (Physical activity and nutrition)- Consists of organized physical activity and controlled serving sizes of healthy low fat snacks |
| YMCA Standard CAre | Experimental | Other: Healthy Snacks and Organized Physical ActivityYMCA standard care - Follow the standard care of the YMCA after school Y-Care program for physical activity and nutrition |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- kindergarten through second grade age;
Key exclusion criteria (1 listed)
- no BMI requirements but must meet age requirements and be available throughout the duration of the study
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 Snacks and Organized Physical ActivityAlso: YMCA PAN, YMCA Standard CareChildren in the intervention group will receive healthy snacks, smaller portion sizes and participate in organized physical activity on a daily bais | Other | YMCA PAN, YMCA Standard CAre |
Primary outcome
Body Mass Index (BMI)
Time frame: 3 years
Body weight and height will be measured in order to calculate BMI
2 secondary outcomes
Daily physical activity levels
Time frame: Daily
Daily energy intake
Time frame: Daily
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 9 Jan 2014.
Related trials for Childhood Obesity
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
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.
Joseph E Donnelly, EdD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Snacks and Organized Physical Activity in people with Childhood Obesity, run by University of Kansas 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 9 Jan 2014. 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?
Body Mass Index (BMI) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2014.