Skip to main content
OpenTrials
Completed

NCT Number: NCT02142452

Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Body Weight Body Weight Changes Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral intervention

Behavioral

Behavioral intervention will include a group class for women in their 3rd trimester followed by a mobile texting program to support behavior change postpartum.

Usual Prenatal Care

Other

Primary outcomes

  1. BMI (body mass index)

    Time frame: 4 months postpartum

    A mobile Health intervention tailored for the 30 postpartum mother and grounded in behavioral change theory will be associated with significantly more reduction in BMI than 30 women not enrolled in the intervention.

Secondary outcomes

  1. Cardiovascular health metrics

    Time frame: 4 months postpartum

    (1) Examine changes in cardiovascular health metrics (fasting glucose, fasting insulin, and BP) and markers of inflammation (hs-CRP) verses control group (2) We will evaluate changes in perceived nutrition, physical activity, and weight-loss self-efficacy; self-efficacy has been shown to be a direct predictor of behavior (3) measure the effects of breastfeeding support on the length of time a mother breastfeeds verse the control group.

  2. Change in self efficacy score based on behavioral self-efficacy scale

    Time frame: 4 months postpartum

    We will measure changes in pre- and post-intervention self-efficacy of all women in intervention and control arms.

  3. Cardiovascular health metrics

    Time frame: 4 months postpartum

    We will evaluate changes in perceived nutrition, physical activity, and weight-loss self-efficacy; self-efficacy has been shown to be a direct predictor of behavior

  4. Cardiovascular health metric

    Time frame: 4 months postpartum

    Measure the effects of breastfeeding support on the length of time a mother breastfeeds verse the control group.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 20, 2014
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.