Childhood ObesityNCT00153322
Shape Up Somerville: Eat Smart Play Hard
A study testing Nurtition and Physical Activity Education in people with Childhood Obesity, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
Community-based environmental approach to obesity prevention targeting first, second, and third grade students in Somerville, MA. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Nurtition and Physical Activity Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Jun 2005
- 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 5 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Public school students in 1st, 2nd, and 3rd grade in Somerville, MA
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University, Friedman School of Nutrition
Boston, Massachusetts, 02111
About this study
Community-based environmental approach to obesity prevention targeting first, second, and third grade students in Somerville, MA.
Read the detailed description
This study will demonstrate using measures of effectiveness, the feasibility of partnering with the community to create, disseminate, implement and evaluate Shape Up Somerville: Eat Smart. Play Hard., a community-based environmental change intervention to prevent obesity in culturally diverse, high-risk, early elementary school children. Based on formative work with parents, children, teachers, school food service, school officials, and community members, a community-wide campaign will be developed with targeted environmental change strategies for early elementary school children within the before-, during-, and after-school environments reinforced by changes within the home and community to support behavioral action and maintenance. The intervention targeting children will bring the energy equation into balance by offering numerous physical activity options that total up to 125 kcals per day and by improving the composition of the food served and the dietary options, particularly snack foods, available throughout the day. This study will measure awareness and participation of the partners and residents within the community. In addition the temporal change in BMI z-score will be monitored internally in 700 Somerville children and externally in 1000 control children from 2 demographically-matched communities for one year and will be compared to the change in BMI z-score in children participating in Shape Up Somerville with children from control communities over the one-year intervention and for one year of follow up. If successful, Somerville will serve as the model community that paves the way for cost-effective nationwide environmental action to prevent obesity at the community level.
- Conditions
- Childhood Obesity
- Being tested
- Nurtition and Physical Activity Education
- Keywords
- Childhood Obesity, Community-based Participatory Research, School intervention, Parental Involvement
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurtition and Physical Activity EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI at one year
Dietary Behavior at one year
Physical Activity Behavior at one year
Nutrition Policy and Infrastructure Outcomes
Secondary outcomes (1)
Nutrition Policy and Infrastructure Outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 2002
- Study completionJun 2005
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 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
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Tufts University
- Investigators
- Christina D. Economos, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153322
- Sponsor's protocol ID
- CDC-OPHR-121519
- Other IDs
- R06 CCR 121519
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Publications
Folta SC, Kuder JF, Goldberg JP, Hyatt RR, Must A, Naumova EN, Nelson ME, Economos CD. Changes in diet and physical activity resulting from the Shape Up Somerville community intervention. BMC Pediatr. 2013 Oct 4;13:157. doi: 10.1186/1471-2431-13-157.
PubMed 24093936
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shape Up Somerville: Eat Smart Play Hard
- ClinicalTrials.gov ID
- NCT00153322
- Acronym / sponsor ID
- CDC-OPHR-121519
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity, Community-based Participatory Research, School intervention, Parental Involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Tufts University
- Study start
- Nov 2002
- Study completion
- Jun 2005
- First posted
- 12 Sep 2005 (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.
Community-based environmental approach to obesity prevention targeting first, second, and third grade students in Somerville, MA.
Detailed description
This study will demonstrate using measures of effectiveness, the feasibility of partnering with the community to create, disseminate, implement and evaluate Shape Up Somerville: Eat Smart. Play Hard., a community-based environmental change intervention to prevent obesity in culturally diverse, high-risk, early elementary school children. Based on formative work with parents, children, teachers, school food service, school officials, and community members, a community-wide campaign will be developed with targeted environmental change strategies for early elementary school children within the before-, during-, and after-school environments reinforced by changes within the home and community to support behavioral action and maintenance. The intervention targeting children will bring the energy equation into balance by offering numerous physical activity options that total up to 125 kcals per day and by improving the composition of the food served and the dietary options, particularly snack foods, available throughout the day. This study will measure awareness and participation of the partners and residents within the community. In addition the temporal change in BMI z-score will be monitored internally in 700 Somerville children and externally in 1000 control children from 2 demographically-matched communities for one year and will be compared to the change in BMI z-score in children participating in Shape Up Somerville with children from control communities over the one-year intervention and for one year of follow up. If successful, Somerville will serve as the model community that paves the way for cost-effective nationwide environmental action to prevent obesity at the community level.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Public school students in 1st, 2nd, and 3rd grade in Somerville, MA
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Nurtition and Physical Activity Education | Behavioural | – |
Primary outcome
BMI at one year
Dietary Behavior at one year
Physical Activity Behavior at one year
Nutrition Policy and Infrastructure Outcomes
1 secondary outcome
Nutrition Policy and Infrastructure Outcomes
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 12 Sep 2005.
- Derived from this study: PubMed 24093936Folta SC, Kuder JF, Goldberg JP, Hyatt RR, Must A, Naumova EN, Nelson ME, Economos CD. Changes in diet and physical activity resulting from the Shape Up Somerville community intervention. BMC Pediatr. 2013 Oct 4;13:157. doi: 10.1186/1471-2431-13-157.
Related trials for Childhood Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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.
Christina D. Economos, PhD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurtition and Physical Activity Education in people with Childhood Obesity, run by Centers for Disease Control and Prevention 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 12 Sep 2005. 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 at one year. 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 NCT00153322, 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 12 Sep 2005.