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

This study is not yet open for participant recruitment.

Verified December 2012 by Pennington Biomedical Research Center

Sponsor:

Collaborators:

University of California, Los Angeles

USDA Beltsville Human Nutrition Research Center

Information provided by (Responsible Party):

Leanne Redman, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT01751230

First received: December 13, 2012

Last updated: December 14, 2012

Last verified: December 2012

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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:

MedlinePlus related topics: Postpartum Care Weight Control

U.S. FDA Resources

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:

Body weight [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dietary Intake [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2013
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	December 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.

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:

WIC Moms: receive advice and services for nutrition and weight management after pregnancy from their WIC clinic.
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

Ages Eligible for Study:	18 Years and older
Genders 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 twins 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751230

Contacts

Contact: Anne Gilmore, Ph.D.	225-763-2848	anne.gilmore@pbrc.edu
Contact: Elizabeth Frost, B.S.	225-763-2794	Elizabeth.frost@pbrc.edu

Locations

United States, Louisiana
Pennington Biomedical Research Center	Not yet recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Leanne Redman, M.S., Ph.D. 225-763-0947 leanne.redman@pbrc.edu
Contact: Elizabeth Frost, B.S. 225-763-2794 elizabeth.frost@pbrc.edu
Principal Investigator: Leanne Redman, M.S., Ph.D.
Sub-Investigator: Corby Martin, Ph.D.
Sub-Investigator: Frank Greenway, M.D.

Sponsors and Collaborators

Pennington Biomedical Research Center

University of California, Los Angeles

USDA Beltsville Human Nutrition Research Center

Investigators

Principal Investigator:

Leanne Redman, M.S., Ph.D.

Pennington Biomedical Research Center

More Information

No publications provided

Responsible Party:	Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT01751230 History of Changes
Other Study ID Numbers:	PBRC12030
Study First Received:	December 13, 2012
Last Updated:	December 14, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:

pregnancy
weight loss

Additional relevant MeSH terms:

Urinary Retention
Weight Loss
Urination Disorders
Urologic Diseases

Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013

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