Prevention of Postpartum Weight Retention in Low Income WIC Women

August 27, 2020 updated by: Suzanne Phelan, California Polytechnic State University-San Luis Obispo
This study will examine the effects of an online behavioral intervention to promote weight loss in low income postpartum women in the WIC program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

371

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93401
        • California Polytechnic State University
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Internet-based treatment for weight loss
No Intervention: Standard WIC care
The control group will received Standard Care as provided through WIC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calorie Intake
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Polytechnic State University-San Luis Obispo

Collaborators

University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 29, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

August 27, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DK087889-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Online postpartum weight control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe