A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women

Postpartum Weight Retention Clinical Trial

— E-Moms  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751230
• Other study ID #: PBRC 12030
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Postpartum Weight Retention
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	United States Department of Agriculture (USDA), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight Change	The primary outcome measure is weight change after the 16 week intervention.	Baseline and 16 weeks