ObesityPhase 1/2ADVANCENCT00359957
Efficacy of Increasing Physical Activity to Reduce Children's Visceral Fat
A Phase 1/2 study testing Pediatric Obesity Intervention (STANDARD) and Pediatric Obesity Intervention + High Activity (ADDED) in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
The purpose of this trial is to examine whether adding greater physical activity to standard family-based behavioral pediatric obesity treatment decreases the amount of visceral fat among treated overweight children. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Obesity
- What is being tested?
- Pediatric Obesity Intervention (STANDARD) and Pediatric Obesity Intervention + High Activity (ADDED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Dec 2007
- Phase
- Phase 1/2
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 7-12 years old
- >85th percentile BMI
- have at least one parent with a BMI>25
- able to engage in at least moderate intensity physical activity
- child and parent willing and able to participate in behavioral treatment
- English-speaking
Who cannot join
- child or parent already enrolled in another weight control program
- child or parent with a medical condition known to affect weight or growth
- child or parent with significant mental illness that would interfere with engaging in treatment
- child or parent with a current or past diagnosed eating disorder
- child or parent currently taking any medication that affects weight or growth
- child who is more than 120% above their median BMI for age and gender
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital and Regional Medical Center
Seattle, Washington, 98115
About this study
Official title: Activity, Diet, and Visceral Adiposity: New Care Emerging (ADVANCE) Project
The purpose of this trial is to examine whether adding greater physical activity to standard family-based behavioral pediatric obesity treatment decreases the amount of visceral fat among treated overweight children.
Read the detailed description
Adult studies suggest that greater visceral fat confers more health risk than peripheral fat accumulation and that physical activity interventions (as part of general weight control interventions) are efficacious in reducing adults' visceral fat. There are few studies examining the impact of physical activity and/or general weight loss on children's visceral fat accumulation. The present study compares standard family-based behavioral weight control treatment for pediatric obesity (STANDARD) with standard treatment plus added emphasis on participants attaining high levels of physical activity (ADDED). Both conditions receive the same behavioral dietary intervention and therapeutic contact and attention. The ADDED condition receives the recommendation and goal to be active at least 90 minutes per day, with behavioral strategies targeting increasing and sustaining these high levels of physical activity.
- Conditions
- Obesity
- Being tested
- Pediatric Obesity Intervention (STANDARD), Pediatric Obesity Intervention + High Activity (ADDED)
- Keywords
- Pediatric obesity, Physical activity, Visceral fat, Weight
- Medical subject headings
- Obesity, Pediatric Obesity, Motor Activity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Obesity Intervention (STANDARD)Behavioural
14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)
Pediatric Obesity Intervention + High Activity (ADDED)Behavioural
14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ADDED condition - behavioral intervention for modifying diet and physical activity, with greater emphasis on physical activity than the STANDARD condition Receives: Behavioral: Pediatric Obesity Intervention + High Activity (ADDED) |
| 2 | Active comparator | STANDARD condition - behavioral intervention for modifying diet, with little emphasis on physical activity Receives: Behavioral: Pediatric Obesity Intervention (STANDARD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral adiposity
Measured: Change over 3-4 month period
Secondary outcomes (4)
Subcutaneous abdominal adiposity
Measured: Change over 3-4 month period
Total body fat
Measured: Change over 3-4 month period
Body mass index
Measured: Change over 3-4 month period
Physical activity
Measured: Change over 3-4 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionDec 2007
- Study completionDec 2007
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 ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Seattle Children's Hospital
- Investigators
- Brian E Saelens, Ph.D., Principal investigator, Children's Hospital and Regiona Medical Center, Seattle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359957
- Sponsor's protocol ID
- DK60476 (completed)
- Other IDs
- NIH/NIDDK K23 DK60476
- Acronym
- ADVANCE
- Status last verified
- Mar 2010
- First submitted
- 1 Aug 2006
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saelens BE, Grow HM, Stark LJ, Seeley RJ, Roehrig H. Efficacy of increasing physical activity to reduce children's visceral fat: a pilot randomized controlled trial. Int J Pediatr Obes. 2011 Apr;6(2):102-12. doi: 10.3109/17477166.2010.482157. Epub 2010 Jun 7.
PubMed 20528109
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity, Diet, and Visceral Adiposity: New Care Emerging (ADVANCE) Project
- ClinicalTrials.gov ID
- NCT00359957
- Acronym / sponsor ID
- ADVANCE / DK60476 (completed)
- Conditions
- Obesity
- Keywords
- Pediatric obesity, Physical activity, Visceral fat, Weight
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Seattle Children's Hospital
- Study start
- Jul 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 3 Aug 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 trial is to examine whether adding greater physical activity to standard family-based behavioral pediatric obesity treatment decreases the amount of visceral fat among treated overweight children.
Detailed description
Adult studies suggest that greater visceral fat confers more health risk than peripheral fat accumulation and that physical activity interventions (as part of general weight control interventions) are efficacious in reducing adults' visceral fat. There are few studies examining the impact of physical activity and/or general weight loss on children's visceral fat accumulation. The present study compares standard family-based behavioral weight control treatment for pediatric obesity (STANDARD) with standard treatment plus added emphasis on participants attaining high levels of physical activity (ADDED). Both conditions receive the same behavioral dietary intervention and therapeutic contact and attention. The ADDED condition receives the recommendation and goal to be active at least 90 minutes per day, with behavioral strategies targeting increasing and sustaining these high levels of physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)ADDED condition - behavioral intervention for modifying diet and physical activity, with greater emphasis on physical activity than the STANDARD condition |
| 2 | Active comparator | Behavioral: Pediatric Obesity Intervention (STANDARD)STANDARD condition - behavioral intervention for modifying diet, with little emphasis on physical activity |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 7-12 years old
- >85th percentile BMI
- have at least one parent with a BMI>25
- able to engage in at least moderate intensity physical activity
- child and parent willing and able to participate in behavioral treatment
Key exclusion criteria (6 listed)
- child or parent already enrolled in another weight control program
- child or parent with a medical condition known to affect weight or growth
- child or parent with significant mental illness that would interfere with engaging in treatment
- child or parent with a current or past diagnosed eating disorder
- child or parent currently taking any medication that affects weight or growth
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 |
|---|---|---|
| Pediatric Obesity Intervention (STANDARD)14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes) | Behavioural | 2 |
| Pediatric Obesity Intervention + High Activity (ADDED)14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes) | Behavioural | 1 |
Primary outcome
Visceral adiposity
Time frame: Change over 3-4 month period
4 secondary outcomes
Subcutaneous abdominal adiposity
Time frame: Change over 3-4 month period
Total body fat
Time frame: Change over 3-4 month period
Body mass index
Time frame: Change over 3-4 month period
Physical activity
Time frame: Change over 3-4 month period
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 2 Mar 2010.
- Derived from this study: PubMed 20528109Saelens BE, Grow HM, Stark LJ, Seeley RJ, Roehrig H. Efficacy of increasing physical activity to reduce children's visceral fat: a pilot randomized controlled trial. Int J Pediatr Obes. 2011 Apr;6(2):102-12. doi: 10.3109/17477166.2010.482157. Epub 2010 Jun 7.
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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.
Brian E Saelens, Ph.D. principal investigator
Children's Hospital and Regiona Medical Center, Seattle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pediatric Obesity Intervention (STANDARD) and Pediatric Obesity Intervention + High Activity (ADDED) in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 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 2 Mar 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visceral adiposity (time frame: Change over 3-4 month period). 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 NCT00359957, 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 2 Mar 2010.