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A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women (E-Moms)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751230
First Posted: December 17, 2012
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of California, Los Angeles
United States Department of Agriculture (USDA)
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center
  Purpose
The purpose of this study is to help women lose the weight they gained during their pregnancy using a SmartPhone app the investigators have developed called E-Moms. The investigators hypothesize that the moms given the app to use during the study will lose more weight than the moms who do not use the app.

Condition Intervention
Postpartum Weight Retention Behavioral: WIC E-Moms

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: E-Moms: A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women

Resource links provided by NLM:


Further study details as provided by Leanne Redman, Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Body weight [ Time Frame: 6 months postpartum ]

Secondary Outcome Measures:
  • Dietary Intake [ Time Frame: 6 months postpartum ]

Enrollment: 40
Study Start Date: August 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WIC E-Moms
If picked for this group, you will receive a personalized diet and exercise plan to help you lose the weight you gained during your pregnancy. All information will be given to you using a SmartPhone, such as an iPhone. You can use your own phone or one can be loaned to you for the study. You will also be loaned a scale so you can weigh yourself at home. You will also get advice and services from your WIC clinic.
Behavioral: WIC E-Moms
Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
Other Name: E-Moms
No Intervention: WIC Moms
You will get advice and services for nutrition and weight management after pregnancy from your WIC clinic.

Detailed Description:

The E-Moms Study will last about 4 months. The weight management program is 4 months long and will end about 6 months after the participant's baby is born. All participants will receive Women, Infants and Children (WIC) services.

For the weight management program, participants will be put into one of these groups:

  1. WIC Moms: receive advice and services for nutrition and weight management after pregnancy from their WIC clinic.
  2. WIC E-Moms: receive a personalized diet and exercise plan to help them lose the weight they gained during their pregnancy. All information will be given to them using a SmartPhone, such as an iPhone. They will also get advice and services from your WIC clinic.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are a female who has delivered a baby within the last 2 months
  • Are 18 years of age or older
  • Have a body mass index ≥25 kg/m2 or <40 kg/m2
  • Are accepted for post-pregnancy WIC services
  • Are English-speaking

Exclusion Criteria:

  • Are participating in the Nurse Family Partnership program
  • Had multiples in your most recent pregnancy
  • Are unwilling to be assigned at random to either of the 2 study groups
  • Are planning to move out of the study area within the next 6 months
  • Have a history of psychiatric conditions or chronic disease than can impact body weight, appetite, or energy intake such as HIV/AIDS, cancer, bipolar disorder or schizophrenia
  • Currently use antipsychotic medications or have used such medications in the previous 12 months
  • Have been diagnosis with type I diabetes
  • Report having a heart attack, stroke, or being hospitalized or treated for chest pain
  • Currently taking medications or supplements to aid in weight loss
  • Have had weight loss surgery in the past year or plan to have it prior to study completion.
  • Currently participating in another interventional study that influences weight control
  • Currently abusing drugs or alcohol (up to 14 drinks per week allowed)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751230


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
University of California, Los Angeles
United States Department of Agriculture (USDA)
Investigators
Principal Investigator: Leanne Redman, M.S., Ph.D. Pennington Biomedical Research Center
  More Information

Responsible Party: Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01751230     History of Changes
Other Study ID Numbers: PBRC 12030
First Submitted: December 13, 2012
First Posted: December 17, 2012
Last Update Posted: October 31, 2017
Last Verified: January 2017

Keywords provided by Leanne Redman, Pennington Biomedical Research Center:
pregnancy
weight loss

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes