A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women (E-Moms)
Primary Purpose
Postpartum Weight Retention
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WIC E-Moms
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Weight Retention focused on measuring pregnancy, weight loss
Eligibility 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)
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
WIC E-Moms
WIC Moms
Arm Description
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.
You will get advice and services for nutrition and weight management after pregnancy from your WIC clinic.
Outcomes
Primary Outcome Measures
Body Weight Change
The primary outcome measure is weight change after the 16 week intervention.
Secondary Outcome Measures
Full Information
NCT ID
NCT01751230
First Posted
December 13, 2012
Last Updated
August 23, 2021
Sponsor
Pennington Biomedical Research Center
Collaborators
University of California, Los Angeles, United States Department of Agriculture (USDA)
1. Study Identification
Unique Protocol Identification Number
NCT01751230
Brief Title
A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women
Acronym
E-Moms
Official Title
E-Moms: A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
University of California, Los Angeles, United States Department of Agriculture (USDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Weight Retention
Keywords
pregnancy, weight loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WIC E-Moms
Arm Type
Experimental
Arm Description
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.
Arm Title
WIC Moms
Arm Type
No Intervention
Arm Description
You will get advice and services for nutrition and weight management after pregnancy from your WIC clinic.
Intervention Type
Behavioral
Intervention Name(s)
WIC E-Moms
Other Intervention Name(s)
E-Moms
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Weight Change
Description
The primary outcome measure is weight change after the 16 week intervention.
Time Frame
Baseline and 16 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Redman, M.S., Ph.D.
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study data available upon request and following appropriate data transfer agreements in place.
Learn more about this trial
A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women
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