Prevention of Postpartum Weight Retention in Low Income WIC Women

Obesity Clinical Trial

Official title:

Prevention of Postpartum Weight Retention in Low Income WIC Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408147
• Other study ID #: 1R01DK087889-01A1
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2020
• Source: California Polytechnic State University-San Luis Obispo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gestational Weight Gain
• Obesity

Intervention

Behavioral:
• Online postpartum weight control
The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	California Polytechnic State University	San Luis Obispo	California

Sponsors (2)

Lead Sponsor	Collaborator
California Polytechnic State University-San Luis Obispo	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (3)

Martin CL, Tate DF, Schaffner A, Brannen A, Hatley KE, Diamond M, Munoz-Christian K, Pomeroy J, Sanchez T, Mercado A, Hagobian T, Phelan S. Acculturation Influences Postpartum Eating, Activity, and Weight Retention in Low-Income Hispanic Women. J Womens Health (Larchmt). 2017 Dec;26(12):1333-1339. doi: 10.1089/jwh.2016.6154. Epub 2017 Aug 17. — View Citation

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 — View Citation

Phelan S, Hagobian T, Brannen A, Hatley KE, Schaffner A, Muñoz-Christian K, Tate DF. Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial. JAMA. 2017 Jun 20;317(23):2381-2391. doi: 10.1001/jama.2017.7119. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months.; The primary outcome is change from entry to the endpoint at 12 months.	12 months
Secondary	Calorie Intake	Calorie intake was measured over time at study entry, 6 and 12 months. The primary outcome is change from entry to 12 months.	12 months