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ObesityNCT00212251

Promoting Postpartum Weight Loss in Overweight Women

A study testing moderate exercise and healthy, low-fat diet in people with Obesity, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
moderate exercise and healthy, low-fat diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteUnited States
Study dates
Aug 2004to Apr 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Hemodynamically significant heart disease
  • Restrictive lung disease
  • Severe anemia
  • Unevaluated maternal cardiac arrythmia
  • Chronic bronchitis
  • Poorly controlled Type 1 diabetes
Show all 10Show fewer
  • Poorly controlled hypertension
  • Orthopedic limitations
  • Poorly controlled seizure disorder
  • Poorly controlled hyperthyroidism

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

Read the detailed description

Retention of weight gained in pregnancy contributes to the development of overweight and obesity in middle age, now at epidemic proportions in America. While interventions to reduce weight retention specifically targeting the postpartum period have been few, interventions that promote modest weight loss starting in early postpartum are safe and could be efficacious, particularly for women who were overweight prior to pregnancy. Moreover, postpartum-related changes in cognitive factors (risk perceptions), behavioral factors (physical activity, diet), self concept (self-esteem) and social role (work, food preparation, child care) may make this time a "teachable moment" that could be capitalized upon by formal interventions. Interventions could leverage natural weight changes to encourage adoption of a healthy diet and increase physical activity, which together could accelerate and/or increase natural weight loss in postpartum. Whether the postpartum period is a teachable moment for weight loss interventions can be investigated empirically.

Conditions
Obesity
Being tested
moderate exercise and healthy, low-fat diet
Keywords
obesity, postpartum period, exercise, diet, motivation
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • moderate exercise and healthy, low-fat dietBehavioural

Study groups in NCT00212251
Study groupRoleWhat they receive
Lifestyle counselingExperimental10 ActiveMoms classes, 8 Moms Time Out nutrition classes, 6 coaching calls, supportive materials
Receives: Behavioral: moderate exercise and healthy, low-fat diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startAug 2004
  3. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00212251
Sponsor's protocol ID
Pro00012546
Other IDs
R01DK064986, DK64986, Duke IRB #4399
Status last verified
Jan 2010
First submitted
19 Sep 2005
Last updated
15 Jul 2014
Results posted
No

Publications

  • 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.

    PubMed 19049350

  • 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.

    PubMed 19595557

  • 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.

    PubMed 21885890

  • 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.

    PubMed 21185967

  • 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.

    PubMed 20821042

Questions about this trial

What is this clinical trial studying?

A study testing moderate exercise and healthy, low-fat diet in people with Obesity, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00212251, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.

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