Overview

This trial is active, not recruiting.

Conditions pregnancy, weight gain
Treatments behavioral intervention, usual prenatal care
Sponsor Stanford University
Start date March 2014
End date August 2016
Trial size 55 participants
Trial identifier NCT02142452, 28810

Summary

The investigators will test the efficacy of a tailored behavioral lifestyle modification program to support cardiovascular health in postpartum women with excessive gestational weight gain. This program will include a mobile health texting component postpartum to support changes in nutrition and physical activity. The investigators will randomize women into either the control arm (usual care) or the intervention (usual care + mobile health program postpartum). The women will be recruited during their 3rd trimester once they have been identified as gaining too much weight according to the 2009 IOM guidelines during pregnancy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Behavioral intervention. Women with excessive weight gain in pregnancy will be recruited in their 3rd trimester. They will begin with a 5 week group session on weight management. After they deliver the baby, they will begin receiving text messages supporting behavior change they learned in their 3rd trimester. They will follow up at 6 weeks postpartum and 4 months postpartum.
behavioral intervention
Behavioral intervention will include a group class for women in their 3rd trimester followed by a mobile texting program to support behavior change postpartum.
(Placebo Comparator)
Women will receive usual prenatal care from their OB. Postpartum, they will receive a monthly newsletter relevant to the new mother on her nutrition and physical activity. They will be followed at 6 weeks postpartum and 4 months postpartum.
usual prenatal care

Primary Outcomes

Measure
BMI (body mass index)
time frame: 4 months postpartum

Secondary Outcomes

Measure
Cardiovascular health metrics
time frame: 4 months postpartum
Change in self efficacy score based on behavioral self-efficacy scale
time frame: 4 months postpartum
Cardiovascular health metrics
time frame: 4 months postpartum
Cardiovascular health metric
time frame: 4 months postpartum

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: - Pregnant woman diagnosed with excessive gestational weight at 24 weeks gestation or later - Age 18 years or older - English-speaking, and willing and able to participate in the proposed intervention. Exclusion Criteria: - Inability to provide informed consent and/or an inability to speak, read, or understand English - Primary residence is outside of the immediate catchment area of 10 miles - Physical or mental challenges that precludes them from exercising or returning for scheduled study follow ups - Concurrent enrollment in another behavior modification program

Additional Information

Official title Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain
Principal investigator Sandra A Tsai, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Stanford University.