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

NCT01751230 | Completed Results

• 1 other identifier: PBRC 12030
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Weight Retention

Keywords

pregnancy; weight loss

Outcome Measures

Primary Outcomes (1)

• Body Weight Change

  The primary outcome measure is weight change after the 16 week intervention.

  Baseline and 16 weeks

Study Arms (2)

WIC E-Moms

EXPERIMENTAL

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

WIC Moms

NO INTERVENTION

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

Interventions

WIC E-Moms 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.

Also known as: E-Moms

WIC E-Moms

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• University of California, Los Angeles: collaborator
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Gestational Weight Gain; Weight Loss

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1\) pilot and feasibility study (small sample size), 2) Variable adherence to the intervention, 3) greater lost to follow-up in the control group.

Results Point of Contact

• Title: Dr. Leanne Redman
• Organization: Pennington Biomedical Research Center

leanne.redman@pbrc.edu

2257630947

Study Officials

• Leanne Redman, M.S., Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: August 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 24, 2021
• Results First Posted: March 26, 2019

Record last verified: 2021-08

Locations

US (1)