Achieving Energy Balance in Post Partum Teens (BALANCE)

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

Status

Completed

Conditions

Intervention / Treatment

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.

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.

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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