Childhood ObesityNCT01374646
Community-based Program to Treat Childhood Obesity
A study testing JOIN Intervention in people with Childhood Obesity, run by UnitedHealth Group at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- JOIN Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2011to 5 Jun 2012
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and teens between the ages of 6-17
- BMI percentile ≥85
- Participation of a parent/guardian
Who cannot join
- Enrollment in another weight loss program or study
- Diagnosis of type 1 or type 2 diabetes
- Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite
- Medications (e.g., steroids) that affect weight or appetite
- Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
YMCA of Greater Providence
Providence, Rhode Island, 02903
About this study
Official title: Effects of a Community-based Program to Treat Childhood and Adolescent Obesity
This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.
Read the detailed description
This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study.
This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include:
- Parental involvement
- Reduction in consumption of sugar sweetened beverages
- Reduction of screen time
- Self-monitoring
- Physical activity
- Stimulus control
- Conditions
- Childhood Obesity
- Being tested
- JOIN Intervention
- Keywords
- Childhood Obesity, Group Treatment, Community-based Programs
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOIN InterventionBehavioural
Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight and body mass index (BMI) in children and teens at 6 months
Assess the effects of a community based program on weight change in children ages 6-12 and teens ages 13-17. Assessments will occur at baseline, 3 and 6 months.
Measured: 6 Months
Secondary outcomes (4)
Change in weight and BMI in parent/guardian/care giver at 6 months
Assess the effects of a community based program on weight change in parent/guardian/care givers. Assessments will occur at baseline, 3 and 6 months.
Measured: 6 months
Change in physical activity level in children and teens at 6 months
Assess the effects of a community based program on physical activity level. Accelerometers will be used to access change at baseline, 3 and 6 months.
Measured: 6 months
Changes in intake and sedentary behavior at 6 months
Change in the number of sugar sweetened beverages consumed per day, hours per day on screen time (TV, video games, and computer), and quality of life at 6 months. Assessments will occur at baseline, 3 and 6 months.
Measured: 6 months
Process Outcomes
Assess process outcomes measures, such as attendance and program satisfaction.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study start1 Jan 2011
- Primary completion5 Jun 2012
- Study completion5 Jun 2012
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- UnitedHealth Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Deneen Votja, MD, Principal investigator, UnitedHealth Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374646
- Sponsor's protocol ID
- JOIN2011 10-309
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2011
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Community-based Program to Treat Childhood and Adolescent Obesity
- ClinicalTrials.gov ID
- NCT01374646
- Acronym / sponsor ID
- JOIN2011 10-309
- Conditions
- Childhood Obesity
- Keywords
- Childhood Obesity, Group Treatment, Community-based Programs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- UnitedHealth GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 5 Jun 2012 (actual)
- Study completion
- 5 Jun 2012 (actual)
- First posted
- 16 Jun 2011 (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.
This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.
Detailed description
This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study.
This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include:
- Parental involvement
- Reduction in consumption of sugar sweetened beverages
- Reduction of screen time
- Self-monitoring
- Physical activity
- Stimulus control
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children and teens between the ages of 6-17
- BMI percentile ≥85
- Participation of a parent/guardian
Key exclusion criteria (5 listed)
- Enrollment in another weight loss program or study
- Diagnosis of type 1 or type 2 diabetes
- Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite
- Medications (e.g., steroids) that affect weight or appetite
- Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in 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 |
|---|---|---|
| JOIN InterventionBehavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors. | Behavioural | – |
Primary outcome
Change in weight and body mass index (BMI) in children and teens at 6 months
Time frame: 6 Months
Assess the effects of a community based program on weight change in children ages 6-12 and teens ages 13-17. Assessments will occur at baseline, 3 and 6 months.
4 secondary outcomes
Change in weight and BMI in parent/guardian/care giver at 6 months
Time frame: 6 months
Change in physical activity level in children and teens at 6 months
Time frame: 6 months
Changes in intake and sedentary behavior at 6 months
Time frame: 6 months
Process Outcomes
Time frame: 6 Months
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 23 Jun 2021.
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.
Deneen Votja, MD principal investigator
UnitedHealth Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JOIN Intervention in people with Childhood Obesity, run by UnitedHealth Group 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 5 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 23 Jun 2021. 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?
Change in weight and body mass index (BMI) in children and teens at 6 months (time frame: 6 Months). 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 23 Jun 2021.