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

This study has been completed.
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: October 20, 2014
Last verified: October 2014
  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:


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 ]

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

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 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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: October 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
pregnancy
weight loss

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

ClinicalTrials.gov processed this record on November 27, 2014