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

NCT ID: NCT01751230

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-10-31

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:

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.

Conditions

Postpartum Weight Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

WIC E-Moms

Intervention Type: BEHAVIORAL

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.

WIC Moms

You will get advice and services for nutrition and weight management after pregnancy from your WIC clinic.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

E-Moms

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Leanne Redman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

PBRC 12030

Identifier Type: -

Identifier Source: org_study_id