Pediatric ObesityNCT00863083
Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity
A study testing Multifamily weight management intervention in people with Pediatric Obesity and Pediatric Overweight, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of the study is to examine the extent to which two different reward systems implemented in the context of a multi-family pediatric weight management group differentially promote adoption of healthy eating and activity habits among overweight and obese 8-17 year old youth. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Pediatric Obesity, Pediatric Overweight
- What is being tested?
- Multifamily weight management intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 2009
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patient age 8-17 years
- patient with public insurance managed by Children's Community Health Network
- English speaking patient and parent
- patient body mass index at or above the 85th percentile for age and sex
- parent or legal guardian willing to participate
Who cannot join
- significant patient developmental or cognitive delay
- concurrent involvement in another formal weight management program.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin/Children's Hosptial of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The purpose of the study is to examine the extent to which two different reward systems implemented in the context of a multi-family pediatric weight management group differentially promote adoption of healthy eating and activity habits among overweight and obese 8-17 year old youth. Participants will be randomly assigned to one of two reward conditions: rewards for attendance only or rewards for attendance and goal attainment. We hypothesize that all participants will demonstrate significant increases in healthy nutritional choices and physical activity and significant reductions in sedentary activity from pre-intervention to post intervention. We expect that participants in attendance plus goal attainment reward condition will demonstrate significantly greater improvements than participants in the attendance only condition.
Read the detailed description
Pediatric overweight and obesity are significant public health concerns, and group based interventions incorporating behavioral, nutrition, and activity disciplines have showed modest success in improving youth health and weight status. The role of financial rewards in encouraging attendance at weight management sessions and acquisition of healthy eating and activity habits is not well understood in the context of pediatric weight management, however. Behavior theory suggests that positive reinforcement can increase the frequency of desirable behaviors. As such, the primary goal of the study is to evaluate the role of different reinforcement systems in increasing healthy nutritional choices, increasing physical activity, and decreasing sedentary activity among youth participating in a multifamily group based pediatric overweight/obesity intervention program. An additional aim of the study is to evaluate the role of different levels of rewards in decreasing BMI among youth participating in a multifamily group based pediatric overweight/obesity intervention program. Participants will be randomly assigned to one of two different reward conditions: Condition A (rewards for attendance only) and Condition A+G (rewards for attendance and goal attainment).
Up to 80 participants will be recruited to participate. Eligibility criteria include patient age 8-17 years, patient with public insurance managed by Children's Community Health Network, English speaking patient and parent, and patient body mass index at or above the 85th percentile for age and sex. Exclusion criteria include: significant patient developmental or cognitive delay, or concurrent involvement in another formal weight management program.
Pre and post intervention assessments of anthropometric, psychosocial, nutritional, and physical fitness variables will be conducted, and participants will complete 8 weekly multi-family group-based weight management intervention sessions involving psychology, physical therapy, and dietitian disciplines. Following this intensive phase, families will follow up on a quarterly basis for one year. Families will receive financial rewards for attending program sessions (Conditions A and A+G) and for completing behavioral monitoring assignments (Condition A+G).
- Conditions
- Pediatric Obesity, Pediatric Overweight
- Being tested
- Multifamily weight management intervention
- Keywords
- pediatric obesity, pediatric overweight, multi-family group weight management intervention, financial rewards
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifamily weight management interventionBehavioural
8 week multifamily group weight management intervention incorporating behavioral health, nutrition, and activity disciplines.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Multifamily group weight management intervention plus rewards for program attendance Receives: Behavioral: Multifamily weight management intervention |
| 2 | Active comparator | Multifamily group weight management intervention plus rewards for attendance and goal attainment Receives: Behavioral: Multifamily weight management intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
dietary habits
Measured: pre, post, quarterly follow ups
physical and sedentary activity
Measured: pre, post, quarterly follow ups
Secondary outcomes (2)
body mass index
Measured: pre, post, quarterly follow ups
participant satisfaction
Measured: post intevention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 2009
Why it stopped: Study was terminated due to poor enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Health System, Inc., Wisconsin Department of Health and Family Services
- Investigators
- Rachel Neff Greenley, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863083
- Sponsor's protocol ID
- CHW 08/101
- Status last verified
- Jun 2010
- First submitted
- 16 Mar 2009
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity
- ClinicalTrials.gov ID
- NCT00863083
- Acronym / sponsor ID
- CHW 08/101
- Conditions
- Pediatric Obesity, Pediatric Overweight
- Keywords
- pediatric obesity, pediatric overweight, multi-family group weight management intervention, financial rewards
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to poor enrollment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Health System, Inc., Wisconsin Department of Health and Family Services
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 17 Mar 2009 (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 the study is to examine the extent to which two different reward systems implemented in the context of a multi-family pediatric weight management group differentially promote adoption of healthy eating and activity habits among overweight and obese 8-17 year old youth. Participants will be randomly assigned to one of two reward conditions: rewards for attendance only or rewards for attendance and goal attainment. We hypothesize that all participants will demonstrate significant increases in healthy nutritional choices and physical activity and significant reductions in sedentary activity from pre-intervention to post intervention. We expect that participants in attendance plus goal attainment reward condition will demonstrate significantly greater improvements than participants in the attendance only condition.
Detailed description
Pediatric overweight and obesity are significant public health concerns, and group based interventions incorporating behavioral, nutrition, and activity disciplines have showed modest success in improving youth health and weight status. The role of financial rewards in encouraging attendance at weight management sessions and acquisition of healthy eating and activity habits is not well understood in the context of pediatric weight management, however. Behavior theory suggests that positive reinforcement can increase the frequency of desirable behaviors. As such, the primary goal of the study is to evaluate the role of different reinforcement systems in increasing healthy nutritional choices, increasing physical activity, and decreasing sedentary activity among youth participating in a multifamily group based pediatric overweight/obesity intervention program. An additional aim of the study is to evaluate the role of different levels of rewards in decreasing BMI among youth participating in a multifamily group based pediatric overweight/obesity intervention program. Participants will be randomly assigned to one of two different reward conditions: Condition A (rewards for attendance only) and Condition A+G (rewards for attendance and goal attainment).
Up to 80 participants will be recruited to participate. Eligibility criteria include patient age 8-17 years, patient with public insurance managed by Children's Community Health Network, English speaking patient and parent, and patient body mass index at or above the 85th percentile for age and sex. Exclusion criteria include: significant patient developmental or cognitive delay, or concurrent involvement in another formal weight management program.
Pre and post intervention assessments of anthropometric, psychosocial, nutritional, and physical fitness variables will be conducted, and participants will complete 8 weekly multi-family group-based weight management intervention sessions involving psychology, physical therapy, and dietitian disciplines. Following this intensive phase, families will follow up on a quarterly basis for one year. Families will receive financial rewards for attending program sessions (Conditions A and A+G) and for completing behavioral monitoring assignments (Condition A+G).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Multifamily weight management interventionMultifamily group weight management intervention plus rewards for program attendance |
| 2 | Active comparator | Behavioral: Multifamily weight management interventionMultifamily group weight management intervention plus rewards for attendance and goal attainment |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- patient age 8-17 years
- patient with public insurance managed by Children's Community Health Network
- English speaking patient and parent
- patient body mass index at or above the 85th percentile for age and sex
- parent or legal guardian willing to participate
Key exclusion criteria (2 listed)
- significant patient developmental or cognitive delay
- concurrent involvement in another formal weight management program.
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 |
|---|---|---|
| Multifamily weight management intervention8 week multifamily group weight management intervention incorporating behavioral health, nutrition, and activity disciplines. | Behavioural | 1, 2 |
Primary outcome
dietary habits
Time frame: pre, post, quarterly follow ups
physical and sedentary activity
Time frame: pre, post, quarterly follow ups
2 secondary outcomes
body mass index
Time frame: pre, post, quarterly follow ups
participant satisfaction
Time frame: post intevention
Results and safety
The study was stopped early (reason given: Study was terminated due to poor enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
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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.
Rachel Neff Greenley, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifamily weight management intervention in people with Pediatric Obesity and Pediatric Overweight, run by Medical College of Wisconsin 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 22 Jun 2010. 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 was stopped early (reason given: Study was terminated due to poor enrollment.). Results are not available in the source record.
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?
dietary habits (time frame: pre, post, quarterly follow ups). 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?
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 22 Jun 2010.