Back to resultsPrevention of Postpartum Weight Retention in Low Income WIC Women
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online postpartum weight control
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Postpartum weight retention, Low income women, WIC, Online
Eligibility Criteria
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.
Sites / Locations
- California Polytechnic State University
- University of North Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Treatment Group
Standard WIC care
Arm Description
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.
The control group will received Standard Care as provided through WIC.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01408147
First Posted
July 29, 2011
Last Updated
August 27, 2020
Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT01408147
Brief Title
Prevention of Postpartum Weight Retention in Low Income WIC Women
Official Title
Prevention of Postpartum Weight Retention in Low Income WIC Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Postpartum weight retention, Low income women, WIC, Online
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
371 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard WIC care
Arm Type
No Intervention
Arm Description
The control group will received Standard Care as provided through WIC.
Intervention Type
Behavioral
Intervention Name(s)
Online postpartum weight control
Other Intervention Name(s)
Internet-based treatment for weight loss
Intervention Description
The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
Primary Outcome Measure Information:
Title
Weight
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Calorie Intake
Description
Calorie intake was measured over time at study entry, 6 and 12 months. The primary outcome is change from entry to 12 months.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, PhD.
Organizational Affiliation
California Polytechnic State University-San Luis Obispo
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Polytechnic State University
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28632867
Citation
Phelan S, Hagobian T, Brannen A, Hatley KE, Schaffner A, Munoz-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.
Results Reference
background
PubMed Identifier
28816589
Citation
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.
Results Reference
background
PubMed Identifier
25887964
Citation
Phelan S, Brannen A, Erickson K, Diamond M, Schaffner A, Munoz-Christian K, Stewart A, Sanchez T, Rodriguez VC, Ramos DI, McClure L, Stinson C, Tate DF. 'Fit Moms/Mamas 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.
Results Reference
result
PubMed Identifier
32888250
Citation
Bennion KA, Tate D, Munoz-Christian K, Phelan S. Impact of an Internet-Based Lifestyle Intervention on Behavioral and Psychosocial Factors During Postpartum Weight Loss. Obesity (Silver Spring). 2020 Oct;28(10):1860-1867. doi: 10.1002/oby.22921. Epub 2020 Sep 4.
Results Reference
derived
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Prevention of Postpartum Weight Retention in Low Income WIC Women
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