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Achieving Energy Balance in Post Partum Teens (BALANCE)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01617486
First received: April 2, 2012
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  Purpose

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).


Condition Intervention
Obesity
 Behavioral: BALANCE

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Achieving Energy Balance in Overweight Post Partum Teens

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • BMI change at 6 month post assessment [ Time Frame: Baseline and 6 month post assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • reduce caloric intake [ Time Frame: baseline and 6 month post test ] [ Designated as safety issue: No ]
    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.

  • Engage in moderate intensity walking [ Time Frame: Baseline and 6 month Post test ] [ Designated as safety issue: No ]
    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.

  • Improve their knowledge of energy patterns [ Time Frame: Baseline and 6 month Post test ] [ Designated as safety issue: No ]
    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.

  • Increase frequency of performance of energy patterns [ Time Frame: Baseline and 6 month post test ] [ Designated as safety issue: No ]
    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.


Enrollment: 1325
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BALANCE Behavioral: 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).

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617486

Locations
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63130
Sponsors and Collaborators
Washington University School of Medicine
National Cancer Institute (NCI)
Investigators
Principal Investigator: Debra Haire-Joshu, PhD Washington University in St. Louis
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01617486     History of Changes
Other Study ID Numbers: 201105325, 5R01CA121534
Study First Received: April 2, 2012
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013