Prevention of Postpartum Weight Retention in Low Income WIC Women
This study is currently recruiting participants.
Verified February 2012 by California Polytechnic State University-San Luis Obispo
Sponsor:
California Polytechnic State University-San Luis Obispo
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: February 9, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: Online postpartum weight control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prevention of Postpartum Weight Retention in Low Income WIC Women |
Resource links provided by NLM:
Further study details as provided by California Polytechnic State University-San Luis Obispo:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 430 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
|
No Intervention: Standard WIC care
The control group will received Standard Care as provided through WIC.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Women
- Age 18-40 years.
- Delivery within 6-24 weeks
- Exceed pre-pregnancy weight by at least 6.8 kg (15 pounds)
- Current body mass index (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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408147
Contacts
| Contact: Suzanne Phelan, PhD | 805-756-2087 | sphelan@calpoly.edu |
| Contact: Anna Brannen, B.S | 805-756-5365 | acbranne@calpoly.edu |
Locations
| United States, California | |
| California Polytechnic State University | Recruiting |
| San Luis Obispo, California, United States, 93401 | |
| Contact: Anna Brannen, BS 805-756-5368 acbranne@calpoly.edu | |
| Principal Investigator: Suzanne Phelan, PhD | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States | |
| Contact: Deborah Tate, PhD dtate@unc.edu | |
| Principal Investigator: Deborah Tate, PhD | |
Sponsors and Collaborators
California Polytechnic State University-San Luis Obispo
University of North Carolina, Chapel Hill
Investigators
| Principal Investigator: | Suzanne Phelan, PhD. | California Polytechnic State University-San Luis Obispo |
More Information
No publications provided
| Responsible Party: | Suzanne Phelan, Associate Professor-Principle Investigator, California Polytechnic State University-San Luis Obispo |
| ClinicalTrials.gov Identifier: | NCT01408147 History of Changes |
| Other Study ID Numbers: | 1 RO1 DK087889-01A1 |
| Study First Received: | July 29, 2011 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by California Polytechnic State University-San Luis Obispo:
|
Postpartum weight retention Low income women WIC Online |
Additional relevant MeSH terms:
|
Obesity Urinary Retention Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Urination Disorders Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013