- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01617486
Achieving Energy Balance in Post Partum Teens (BALANCE)
June 8, 2012 updated by: Washington University School of Medicine
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
1325
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
St. Louis, Missouri, United States, 63130
- Washington University in St. Louis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- between 12 to 20 years of age
- less than 1 year post partum
- current participant in Parents as Teachers
Exclusion Criteria:
- currently pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BALANCE
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and 6 month post assessment
|
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
|
Baseline to 1 year post assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reduce caloric intake
Time Frame: baseline and 6 month post test
|
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.
|
baseline and 6 month post test
|
Engage in moderate intensity walking
Time Frame: Baseline and 6 month Post test
|
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.
|
Baseline and 6 month Post test
|
Improve their knowledge of energy patterns
Time Frame: Baseline and 6 month Post test
|
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.
|
Baseline and 6 month Post test
|
Increase frequency of performance of energy patterns
Time Frame: Baseline and 6 month post test
|
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.
|
Baseline and 6 month post test
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Haire-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.
- Haire-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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
April 2, 2012
First Submitted That Met QC Criteria
June 8, 2012
First Posted (Estimate)
June 12, 2012
Study Record Updates
Last Update Posted (Estimate)
June 12, 2012
Last Update Submitted That Met QC Criteria
June 8, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- 201105325
- 5R01CA121534 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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