ObesityPAACNCT01066910
Parents As The Agent Of Change For Childhood Obesity (PAAC)
A study testing Behavioral treatment for childhood obesity in people with Obesity, run by University of Minnesota at 1 site in United States.
Trial summary
The objective of this study is to test and evaluate the effectiveness of a parent-only treatment for childhood obesity. This study provides state-of-the-art treatment for childhood obesity. Parents and children will participate in treatment groups for 6 months. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Obesity
- What is being tested?
- Behavioral treatment for childhood obesity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Apr 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- An overweight child (>95th%) in the family who is between the ages of 8-12.
- A parent willing to participate and attend all treatment meetings.
- Family willing to commit to 6 months of treatment attendance, and follow-up for 6 months post-treatment.
- Family willing to submit the $60 deposit.
Who cannot join
- Child psychiatric disorder diagnoses (based on parent report).
- Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed.
- Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home.
- Child with physical difficulties that limit the ability to exercise.
- Child with an active eating disorder.
- All exclusionary and inclusionary criteria are similar to those in previous studies of Epstein and colleagues and Golan and colleagues.
Trial locations and contacts
1 site in 1 country.
United States1 site
KDWB University Pediatrics Family Center (UMP Stand alone clinic)
Minneapolis, Minnesota, 55455
About this study
The objective of this study is to test and evaluate the effectiveness of a parent-only treatment for childhood obesity. This study provides state-of-the-art treatment for childhood obesity. Parents and children will participate in treatment groups for 6 months. These treatment groups include recommendations to decrease overall caloric intake (by increasing fruits and vegetables), increasing physical activity, decreasing sedentary behavior and changing the home food environment. We are currently implementing this treatment in the Healthy Choices Program which is part of the Childhood Obesity Clinic at the University of Minnesota. Len Epstein at the University of Buffalo has been publishing on this treatment protocol for 30 years.
Read the detailed description
The objective of this study is to pilot test and evaluate the efficacy of a parent-only treatment for childhood obesity. The central working hypothesis is that the parent-only treatment will result in greater weight loss for the overweight child as compared to the parent + child treatment. The specific aims of this application focus on comparing a behavioral parent-only intervention to a parent + child intervention for childhood obesity.
The primary aim of the proposed study is to compare the efficacy of the parent-only treatment to the parent + child treatment for childhood obesity.
The secondary aim is to compare treatment groups on change in the child and parent diet and exercise behavior, change in the home food environment, and parent weight post-treatment and at 6-months post-treatment.
This study is a randomized, clinical pilot trial evaluating two 6-month treatments for childhood obesity; parent + child and parent-only groups, with 6-months of post-treatment follow-up. The two treatments will differ in terms of the designated recipient of treatment, which will be delivered either to parents-only or to parents and children separately. Study outcomes will be assessed at baseline, immediately post-treatment, and 6-months post-treatment.
- Conditions
- Obesity
- Being tested
- Behavioral treatment for childhood obesity
- Keywords
- Obesity, Childhood Obesity, Exercise, Nutrition
- Medical subject headings
- Obesity, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral treatment for childhood obesityBehavioural
Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.
Behavioral treatment for childhood obesityBehavioural
Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.
| Study group | Role | What they receive |
|---|---|---|
| Parent-only | Experimental | Not described Receives: Behavioral: Behavioral treatment for childhood obesity |
| Parent and child | Active comparator | Not described Receives: Behavioral: Behavioral treatment for childhood obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child BMI percentile, Child BMI, Child BMI_Z
Measured: 11 months
Secondary outcomes (1)
Parent BMI, Child nutritional intake, Child physical activity
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startDec 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerri N Boutelle, Ph.D., L.P., Principal investigator, University of Minnesota - Dept of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066910
- Sponsor's protocol ID
- 0611M96906
- Acronym
- PAAC
- Status last verified
- Jul 2012
- First submitted
- 9 Feb 2010
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents As The Agent Of Change For Childhood Obesity (PAAC)
- ClinicalTrials.gov ID
- NCT01066910
- Acronym / sponsor ID
- PAAC / 0611M96906
- Conditions
- Obesity
- Keywords
- Obesity, Childhood Obesity, Exercise, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 10 Feb 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.
The objective of this study is to test and evaluate the effectiveness of a parent-only treatment for childhood obesity. This study provides state-of-the-art treatment for childhood obesity. Parents and children will participate in treatment groups for 6 months. These treatment groups include recommendations to decrease overall caloric intake (by increasing fruits and vegetables), increasing physical activity, decreasing sedentary behavior and changing the home food environment. We are currently implementing this treatment in the Healthy Choices Program which is part of the Childhood Obesity Clinic at the University of Minnesota. Len Epstein at the University of Buffalo has been publishing on this treatment protocol for 30 years.
Detailed description
The objective of this study is to pilot test and evaluate the efficacy of a parent-only treatment for childhood obesity. The central working hypothesis is that the parent-only treatment will result in greater weight loss for the overweight child as compared to the parent + child treatment. The specific aims of this application focus on comparing a behavioral parent-only intervention to a parent + child intervention for childhood obesity.
The primary aim of the proposed study is to compare the efficacy of the parent-only treatment to the parent + child treatment for childhood obesity.
The secondary aim is to compare treatment groups on change in the child and parent diet and exercise behavior, change in the home food environment, and parent weight post-treatment and at 6-months post-treatment.
This study is a randomized, clinical pilot trial evaluating two 6-month treatments for childhood obesity; parent + child and parent-only groups, with 6-months of post-treatment follow-up. The two treatments will differ in terms of the designated recipient of treatment, which will be delivered either to parents-only or to parents and children separately. Study outcomes will be assessed at baseline, immediately post-treatment, and 6-months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-only | Experimental | Behavioral: Behavioral treatment for childhood obesity |
| Parent and child | Active comparator | Behavioral: Behavioral treatment for childhood obesity |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- An overweight child (>95th%) in the family who is between the ages of 8-12.
- A parent willing to participate and attend all treatment meetings.
- Family willing to commit to 6 months of treatment attendance, and follow-up for 6 months post-treatment.
- Family willing to submit the $60 deposit.
Key exclusion criteria (6 listed)
- Child psychiatric disorder diagnoses (based on parent report).
- Child diagnoses of a serious current physical disease (such as diabetes) for which physician supervision of diet and exercise prescription are needed.
- Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home.
- Child with physical difficulties that limit the ability to exercise.
- Child with an active eating disorder.
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 |
|---|---|---|
| Behavioral treatment for childhood obesityBehavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child. | Behavioural | Parent-only |
| Behavioral treatment for childhood obesityBehavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child. | Behavioural | Parent and child |
Primary outcome
Child BMI percentile, Child BMI, Child BMI_Z
Time frame: 11 months
1 secondary outcome
Parent BMI, Child nutritional intake, Child physical activity
Time frame: 11 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 10 Jul 2012.
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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.
Kerri N Boutelle, Ph.D., L.P. principal investigator
University of Minnesota - Dept of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral treatment for childhood obesity in people with Obesity, run by University of Minnesota 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 4 inclusion and 6 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 10 Jul 2012. 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?
Child BMI percentile, Child BMI, Child BMI_Z (time frame: 11 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 10 Jul 2012.