Prevention of Postpartum Weight Retention in Low Income WIC Women

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

University of North Carolina, Chapel Hill

Information provided by (Responsible Party):

Suzanne Phelan, California Polytechnic State University-San Luis Obispo

ClinicalTrials.gov Identifier:

NCT01408147

First received: July 29, 2011

Last updated: October 26, 2015

Last verified: October 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

July 29, 2011

Last Updated Date

October 26, 2015

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

September 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Weight [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Women randomized to the weight loss group will be assessed at study entry, 6 months, and 12 months. Weight is the primary outcome

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01408147 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Psychosocial measures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Behavioral and psychosocial variables will be measured at study entry, 6 and 12 months.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prevention of Postpartum Weight Retention in Low Income WIC Women

Official Title ^ICMJE

Prevention of Postpartum Weight Retention in Low Income WIC Women

Brief Summary

This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.

Detailed Description

This program is designed to reduce postpartum weight retention in low income women in the WIC program. The weight loss program will be delivered over the internet and will use behavioral weight loss techniques.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Behavioral: Online postpartum weight control

The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.

Other Name: Internet-based treatment for weight loss

Study Arm (s)

Active Comparator: Treatment Group
This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.

Intervention: Behavioral: Online postpartum weight control
No Intervention: Standard WIC care
The control group will received Standard Care as provided through WIC.

Publications *

Phelan S, Brannen A, Erickson K, Diamond M, Schaffner A, Muñoz-Christian K, Stewart A, Sanchez T, Rodriguez VC, Ramos DI, McClure L, Stinson C, Tate DF. 'Fit Moms/Mamás Activas' internet-based weight control program with group support to reduce postpartum weight retention in low-income women: study protocol for a randomized controlled trial. Trials. 2015 Feb 25;16:59. doi: 10.1186/s13063-015-0573-9.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

430

Estimated Completion Date

December 2016

Estimated Primary Completion Date

September 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women
Age 18-40 years.
Delivery within 6-52 weeks
Exceed pre-pregnancy weight by at least 4.5 kg (10 pounds) or current body mass index (BMI) >/= 25
Current BMI > 22
English or Spanish speaking
Has internet access at home or a landline
Literacy of at least 5th grade reading level
Has a cell phone

Exclusion Criteria:

Pregnant or planning to become pregnant
Relocating in the next year
Serious psychological problems (untreated depression, schizophrenia, bipolar disorder) or medical problem (i.e. heart disease, cancer, renal disease and diabetes), for which physician supervision of diet and exercise prescription is needed.

Gender

Female

Ages

18 Years to 40 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01408147

Other Study ID Numbers ^ICMJE

1R01DK087889-01A1

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Suzanne Phelan, California Polytechnic State University-San Luis Obispo

Study Sponsor ^ICMJE

California Polytechnic State University-San Luis Obispo

Collaborators ^ICMJE

University of North Carolina, Chapel Hill

Investigators ^ICMJE

Principal Investigator:

Suzanne Phelan, PhD.

California Polytechnic State University-San Luis Obispo

Information Provided By

California Polytechnic State University-San Luis Obispo

Verification Date

October 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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