Cardiovascular Health in Postpartum Women Diagnosed With Excessive Gestational Weight Gain

NCT02142452 | Completed

• 1 other identifier: 28810
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Weight Gain

Keywords

Pregnancy; Obesity/Overweight; postpartum; mobile health; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• BMI (body mass index)

  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.

  4 months postpartum

Secondary Outcomes (4)

• Cardiovascular health metrics

  4 months postpartum

• Change in self efficacy score based on behavioral self-efficacy scale

  4 months postpartum

• Cardiovascular health metrics

  4 months postpartum

• Cardiovascular health metric

  4 months postpartum

Study Arms (2)

mobile health intervention

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: behavioral intervention

Control Group

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.

Other: Usual Prenatal Care

Interventions

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.

mobile health intervention

Usual Prenatal Care OTHER

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Weight Gain; Obesity; Overweight; Cardiovascular Diseases

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sandra A Tsai, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 20, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)