NCT00212251

Brief Summary

The purpose of this study is to evaluate, in a five-year randomized controlled trial, the efficacy of an intervention (AMP - ACTIVE MOTHERS POSTPARTUM) to increase physical activity and promote a healthy diet (decreased calorie and fat intake) for weight loss among postpartum women who were overweight or obese prior to pregnancy. The hypothesis is that the proportion of women losing at least 10% of BMI from baseline to 12 months post-intervention will be significantly greater in the AMP intervention arm than in the minimal care arm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2004

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

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 15, 2014

Status Verified

January 1, 2010

First QC Date

September 19, 2005

Last Update Submit

July 14, 2014

Conditions

Obesity

Keywords

obesitypostpartum periodexercisedietmotivation

Outcome Measures

Primary Outcomes (1)

  • BMI change from baseline to 12 months post-intervention (24 months postpartum) will be assessed via self-report and validated by in-person weight measurement. The proportion of women who lose 10% of baseline BMI

Secondary Outcomes (1)

  • Change in BMI from pre-pregnancy to 12 months post-intervention; proportion below their pre-pregnancy weight at 1, 6 and 12 months post-intervention; and BMI change from baseline to 1 a

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

10 ActiveMoms classes, 8 Moms Time Out nutrition classes, 6 coaching calls, supportive materials

Behavioral: moderate exercise and healthy, low-fat diet

Interventions

moderate exercise and healthy, low-fat dietBEHAVIORAL
Lifestyle counseling

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pre-pregnancy BMI\>24
  • over 18
  • delivered baby in past 6 weeks
  • English speaking
  • driving distance to Duke University Medical Center

You may not qualify if:

  • Hemodynamically significant heart disease
  • Restrictive lung disease
  • Severe anemia
  • Unevaluated maternal cardiac arrythmia
  • Chronic bronchitis
  • Poorly controlled Type 1 diabetes
  • Poorly controlled hypertension
  • Orthopedic limitations
  • Poorly controlled seizure disorder
  • Poorly controlled hyperthyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

  • Ostbye T, Krause KM, Brouwer RJ, Lovelady CA, Morey MC, Bastian LA, Peterson BL, Swamy GK, Chowdhary J, McBride CM. Active Mothers Postpartum (AMP): rationale, design, and baseline characteristics. J Womens Health (Larchmt). 2008 Dec;17(10):1567-75. doi: 10.1089/jwh.2007.0674.

    PMID: 19049350BACKGROUND

  • Ostbye T, Krause KM, Lovelady CA, Morey MC, Bastian LA, Peterson BL, Swamy GK, Brouwer RJ, McBride CM. Active Mothers Postpartum: a randomized controlled weight-loss intervention trial. Am J Prev Med. 2009 Sep;37(3):173-80. doi: 10.1016/j.amepre.2009.05.016.

    PMID: 19595557RESULT

  • Durham HA, Morey MC, Lovelady CA, Namenek Brouwer RJ, Krause KM, Ostbye T. Postpartum physical activity in overweight and obese women. J Phys Act Health. 2011 Sep;8(7):988-93. doi: 10.1123/jpah.8.7.988.

    PMID: 21885890DERIVED

  • Durham HA, Lovelady CA, Brouwer RJ, Krause KM, Ostbye T. Comparison of dietary intake of overweight postpartum mothers practicing breastfeeding or formula feeding. J Am Diet Assoc. 2011 Jan;111(1):67-74. doi: 10.1016/j.jada.2010.10.001.

    PMID: 21185967DERIVED

  • Krause KM, Lovelady CA, Ostbye T. Predictors of breastfeeding in overweight and obese women: data from Active Mothers Postpartum (AMP). Matern Child Health J. 2011 Apr;15(3):367-75. doi: 10.1007/s10995-010-0667-7.

    PMID: 20821042DERIVED

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Truls Ostbye, MD, PhD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 21, 2005

Study Start

August 1, 2004

Study Completion

April 1, 2008

Last Updated

July 15, 2014

Record last verified: 2010-01

Locations

US(1)