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

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Weight Retention
• Intervention / Treatment: Behavioral: WIC E-Moms

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: E-Moms
No Intervention: WIC Moms; You will get advice and services for nutrition and weight management after pregnancy from your WIC clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight Change	The primary outcome measure is weight change after the 16 week intervention.	Baseline and 16 weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: University of California, Los Angeles; United States Department of Agriculture (USDA)
• Investigators: Principal Investigator: Leanne Redman, M.S., Ph.D., Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: December 14, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pregnancy; weight loss
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Gain; Weight Loss; Body Weight; Gestational Weight Gain
• Other Study ID Numbers: PBRC 12030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Study data available upon request and following appropriate data transfer agreements in place.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No