Childhood ObesityNCT00381069
SDSU MOVE/Me Muevo Project
A study testing Family & Community Recreation Center Intervention in people with Childhood Obesity, run by San Diego State University at 1 site in United States.
Trial summary
The purpose of this study is to design, implement, and evaluate a recreation site-based obesity prevention \& control intervention for 7-9 year old children and their families by targeting physical activity and dietary behaviors. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Family & Community Recreation Center Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 541 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2010
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary residence within 3 miles of recreation center
- Children ages 5-8 at baseline
- Commit to participate in study for 3 1/2 years
- Participating parent must be a legal guardian of the child
- Parent and child must be able to speak and read English or Spanish
- Willing to be randomly assigned to control or intervention
Who cannot join
- Child has a medical/health/psychological condition or is taking a medication that may impact the child's physical activity, diet or weight to confound BMI
- Parent or child is unable to read and speak English or Spanish
- Family plans to move during the next 3 1/2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obesity Prevention and Control in Community Recreation Centers
The purpose of this study is to design, implement, and evaluate a recreation site-based obesity prevention \& control intervention for 7-9 year old children and their families by targeting physical activity and dietary behaviors.
Read the detailed description
The primary aim is to evaluate the effectiveness of a multi-level intervention to prevent the onset of overweight and obesity in 7-9 year old children. The recreation center site intervention emphasizes changes in quantity and quality of physical activity and nutrition-related offerings within the centers. The home site intervention targets the home environment and household rule setting delivered via Family Health Coaches and tailored to the needs of the family. Five hundred forty one (541) families were recruited to participate in this project. Participants were selected in part based on residence in proximity to participating recreation centers. Eighteen (18) families living up to 3 miles from each of the 30 recreation centers involved in the project were be recruited to participate. For each family, one child was recruited between the ages of 5 and 8 years old and this child's primary caregiver was enrolled in the study. The study's primary outcome is Body Mass Index (kg/m2).
Comparisons: Control vs. Intervention
- Conditions
- Childhood Obesity
- Being tested
- Family & Community Recreation Center Intervention
- Keywords
- Recreation Centers, Families, Obesity Prevention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family & Community Recreation Center InterventionBehavioural
Also called MOVE/me Muevo Family Health Program
The two year intervention involves changing the environment and policies in community recreation centers to promote physical activity and healthy eating choices. The Recreation Specialist will meet with recreation center staff monthly to create action plans that work towards this goal. Family Health Coaches will be in contact with intervention families twice a month either through a phone consultation, workshop at the recreation center,or home visit. Intervention families will receive a monthly mailing highlighting tips for healthy eating and physical activity. MOVE families will be encouraged to utilize the recreation center as a resource in supporting their child's physical activity and healthy eating behaviors.
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (height & weight) at baseline, 1 year of intervention, and post intervention
Measured: February 2010-August 2010
Secondary outcomes (2)
Child physical activity measured by wearing the ActiGraph accelerometer in a subsample of 1/3 of participants from each center
Measured: February 2010-August 2010
Questionnaire to assess Parent-reported nutrition and eating behaviors,rules about physical activity & nutrition in the home, and physical activity & sedentary behavior at baseline, 2 years, 3 years.
Measured: February 2010-August 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2010
- Study completionAug 2010
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
- Single group
- Masking
- None (open label)
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Elder, San Diego State University
- Investigators
- John P Elder, PhD, MPH, Principal investigator, San Diego State University Graduate School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381069
- Sponsor's protocol ID
- DK72994
- Other IDs
- R01DK072994
- Status last verified
- Aug 2024
- First submitted
- 26 Sep 2006
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity Prevention and Control in Community Recreation Centers
- ClinicalTrials.gov ID
- NCT00381069
- Acronym / sponsor ID
- DK72994
- Conditions
- Childhood Obesity
- Keywords
- Recreation Centers, Families, Obesity Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Sep 2006 (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.
The purpose of this study is to design, implement, and evaluate a recreation site-based obesity prevention \& control intervention for 7-9 year old children and their families by targeting physical activity and dietary behaviors.
Detailed description
The primary aim is to evaluate the effectiveness of a multi-level intervention to prevent the onset of overweight and obesity in 7-9 year old children. The recreation center site intervention emphasizes changes in quantity and quality of physical activity and nutrition-related offerings within the centers. The home site intervention targets the home environment and household rule setting delivered via Family Health Coaches and tailored to the needs of the family. Five hundred forty one (541) families were recruited to participate in this project. Participants were selected in part based on residence in proximity to participating recreation centers. Eighteen (18) families living up to 3 miles from each of the 30 recreation centers involved in the project were be recruited to participate. For each family, one child was recruited between the ages of 5 and 8 years old and this child's primary caregiver was enrolled in the study. The study's primary outcome is Body Mass Index (kg/m2).
Comparisons: Control vs. Intervention
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Primary residence within 3 miles of recreation center
- Children ages 5-8 at baseline
- Commit to participate in study for 3 1/2 years
- Participating parent must be a legal guardian of the child
- Parent and child must be able to speak and read English or Spanish
Key exclusion criteria (3 listed)
- Child has a medical/health/psychological condition or is taking a medication that may impact the child's physical activity, diet or weight to confound BMI
- Parent or child is unable to read and speak English or Spanish
- Family plans to move during the next 3 1/2 years
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 |
|---|---|---|
| Family & Community Recreation Center InterventionAlso: MOVE/me Muevo Family Health ProgramThe two year intervention involves changing the environment and policies in community recreation centers to promote physical activity and healthy eating choices. The Recreation Specialist will meet with recreation center staff monthly to create action plans that work towards this goal. Family Health Coaches will be in contact with intervention families twice a month either through a phone consultation, workshop at the recreation center,or home visit. Intervention families will receive a monthly mailing highlighting tips for healthy eating and physical activity. MOVE families will be encouraged to utilize the recreation center as a resource in supporting their child's physical activity and healthy eating behaviors. | Behavioural | – |
Primary outcome
BMI (height & weight) at baseline, 1 year of intervention, and post intervention
Time frame: February 2010-August 2010
2 secondary outcomes
Child physical activity measured by wearing the ActiGraph accelerometer in a subsample of 1/3 of participants from each center
Time frame: February 2010-August 2010
Questionnaire to assess Parent-reported nutrition and eating behaviors,rules about physical activity & nutrition in the home, and physical activity & sedentary behavior at baseline, 2 years, 3 years.
Time frame: February 2010-August 2010
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 30 Aug 2024.
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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.
John P Elder, PhD, MPH principal investigator
San Diego State University Graduate School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family & Community Recreation Center Intervention in people with Childhood Obesity, run by San Diego State University 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 3 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 30 Aug 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.
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 (height & weight) at baseline, 1 year of intervention, and post intervention (time frame: February 2010-August 2010). 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 30 Aug 2024.