NCT01617486

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,325

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

April 2, 2012

Last Update Submit

June 8, 2012

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Baseline to 1 year post assessment

Secondary Outcomes (4)

  • reduce caloric intake

    baseline and 6 month post test

  • Engage in moderate intensity walking

    Baseline and 6 month Post test

  • Improve their knowledge of energy patterns

    Baseline and 6 month Post test

  • Increase frequency of performance of energy patterns

    Baseline and 6 month post test

Study Arms (1)

BALANCE

EXPERIMENTAL
Behavioral: BALANCE

Interventions

BALANCEBEHAVIORAL

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).

BALANCE

Eligibility Criteria

Age12 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • between 12 to 20 years of age
  • less than 1 year post partum
  • current participant in Parents as Teachers

You may not qualify if:

  • currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Related Publications (3)

  • 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.

    PMID: 21324248RESULT

  • 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.

    PMID: 21185974RESULT

  • 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.

    PMID: 26112041DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Debra Haire-Joshu, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2012

First Posted

June 12, 2012

Study Start

January 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

US(1)