Clinical trial NCT01751230: A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women
Official title: E-Moms: A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Weight Retention
Keywords: pregnancy
weight loss
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: United States Department of Agriculture (USDA)
First posted: 2012-12-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Body Weight Change
timeFrame: Baseline and 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne Redman, M.S., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: