ObesityBALANCENCT01617486
Achieving Energy Balance in Post Partum Teens
A study testing BALANCE in people with Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT) and designed to reduce overweight in postpartum teens. Read more about this study
- Who is it for?
- Ages 12 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- BALANCE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,325 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 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 12 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- between 12 to 20 years of age
- less than 1 year post partum
- current participant in Parents as Teachers
Who cannot join
- currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63130
About this study
Official title: Achieving Energy Balance in Overweight Post Partum Teens
This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT) and designed to reduce overweight in postpartum teens. The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).
- Conditions
- Obesity
- Being tested
- BALANCE
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALANCEBehavioural
The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).
| Study group | Role | What they receive |
|---|---|---|
| BALANCE | Experimental | Not described Receives: Behavioral: BALANCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI change at 6 month post assessment
Postpartum adolescents in the intervention group who are at risk for overweight (85th-94th percentile BMI) or are overweight (equal to or greater than the 95th percentile) at baseline will have a change in BMI with a lower absolute BMI at 6 month post assessment than those in the control group
Measured: Baseline and 6 month post assessment
BMI change at 1 year post assessment
Postpartum adolescents in the intervention group who are at risk for overweight (85th-94th percentile BMI) or are overweight (equal to or greater than the 95th percentile) at baseline will have a change in BMI with a lower absolute BMI at the 1 year post assessment than those in the control group
Measured: Baseline to 1 year post assessment
Secondary outcomes (4)
reduce caloric intake
Our secondary hypotheses are that at the conclusion of the study (6 month post assessment) when compared to the control group, there will be a significantly greater proportion of postpartum adolescents in the intervention group who reduce caloric intake.
Measured: baseline and 6 month post test
Engage in moderate intensity walking
Our secondary hypotheses are that at the conclusion of the study (6 month post assessment) when compared to the control group, there will be a significantly greater proportion of postpartum adolescents in the intervention group who increase moderate intensity walking.
Measured: Baseline and 6 month Post test
Improve their knowledge of energy patterns
Our secondary hypotheses are that at the conclusion of the study (6 month post assessment) when compared to the control group, there will be a significantly greater proportion of postpartum adolescents in the intervention group who improve their knowledge of energy patterns.
Measured: Baseline and 6 month Post test
Increase frequency of performance of energy patterns
Our secondary hypotheses are that at the conclusion of the study (6 month post assessment) when compared to the control group, there will be a significantly greater proportion of postpartum adolescents in the intervention group who increase frequency of performance of energy patterns.
Measured: Baseline and 6 month post test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startJan 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Debra Haire-Joshu, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617486
- Sponsor's protocol ID
- 201105325
- Other IDs
- 5R01CA121534
- Acronym
- BALANCE
- Status last verified
- Jun 2012
- First submitted
- 2 Apr 2012
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Haire-Joshu D, Yount BW, Budd EL, Schwarz C, Schermbeck R, Green S, Elliott M. The quality of school wellness policies and energy-balance behaviors of adolescent mothers. Prev Chronic Dis. 2011 Mar;8(2):A34. Epub 2011 Feb 15.
PubMed 21324248Haire-Joshu D, Schwarz C, Budd E, Yount BW, Lapka C. Postpartum teens' breakfast consumption is associated with snack and beverage intake and body mass index. J Am Diet Assoc. 2011 Jan;111(1):124-30. doi: 10.1016/j.jada.2010.10.009.
PubMed 21185974Haire-Joshu DL, Schwarz CD, Peskoe SB, Budd EL, Brownson RC, Joshu CE. A group randomized controlled trial integrating obesity prevention and control for postpartum adolescents in a home visiting program. Int J Behav Nutr Phys Act. 2015 Jun 26;12:88. doi: 10.1186/s12966-015-0247-8.
PubMed 26112041
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Energy Balance in Overweight Post Partum Teens
- ClinicalTrials.gov ID
- NCT01617486
- Acronym / sponsor ID
- BALANCE / 201105325
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,325 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 12 Jun 2012 (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 proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT) and designed to reduce overweight in postpartum teens. The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BALANCE | Experimental | Behavioral: BALANCE |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- between 12 to 20 years of age
- less than 1 year post partum
- current participant in Parents as Teachers
Key exclusion criteria (1 listed)
- currently pregnant
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 |
|---|---|---|
| BALANCEThe intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking). | Behavioural | BALANCE |
Primary outcome
BMI change at 6 month post assessment
Time frame: Baseline and 6 month post assessment
Postpartum adolescents in the intervention group who are at risk for overweight (85th-94th percentile BMI) or are overweight (equal to or greater than the 95th percentile) at baseline will have a change in BMI with a lower absolute BMI at 6 month post assessment than those in the control group
BMI change at 1 year post assessment
Time frame: Baseline to 1 year post assessment
Postpartum adolescents in the intervention group who are at risk for overweight (85th-94th percentile BMI) or are overweight (equal to or greater than the 95th percentile) at baseline will have a change in BMI with a lower absolute BMI at the 1 year post assessment than those in the control group
4 secondary outcomes
reduce caloric intake
Time frame: baseline and 6 month post test
Engage in moderate intensity walking
Time frame: Baseline and 6 month Post test
Improve their knowledge of energy patterns
Time frame: Baseline and 6 month Post test
Increase frequency of performance of energy patterns
Time frame: Baseline and 6 month post test
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 12 Jun 2012.
- Results publication: PubMed 21324248Haire-Joshu D, Yount BW, Budd EL, Schwarz C, Schermbeck R, Green S, Elliott M. The quality of school wellness policies and energy-balance behaviors of adolescent mothers. Prev Chronic Dis. 2011 Mar;8(2):A34. Epub 2011 Feb 15.
- Results publication: PubMed 21185974Haire-Joshu D, Schwarz C, Budd E, Yount BW, Lapka C. Postpartum teens' breakfast consumption is associated with snack and beverage intake and body mass index. J Am Diet Assoc. 2011 Jan;111(1):124-30. doi: 10.1016/j.jada.2010.10.009.
- Derived from this study: PubMed 26112041Haire-Joshu DL, Schwarz CD, Peskoe SB, Budd EL, Brownson RC, Joshu CE. A group randomized controlled trial integrating obesity prevention and control for postpartum adolescents in a home visiting program. Int J Behav Nutr Phys Act. 2015 Jun 26;12:88. doi: 10.1186/s12966-015-0247-8.
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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.
Debra Haire-Joshu, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BALANCE in people with Obesity, run by Washington University School of Medicine 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 1 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 12 Jun 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?
BMI change at 6 month post assessment (time frame: Baseline and 6 month post assessment). 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?
On the ClinicalTrials.gov record for NCT01617486, which also lists 3 linked publications.
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 12 Jun 2012.