The Health in Pregnancy (HIP) Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00540319
First received: October 4, 2007
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

Pregnancy is a critical time to address preventable behavioral risks that pose serious threats to the health of both the mother and the developing fetus. We propose to conduct a randomized, controlled trial to determine the extent to which the Health in Pregnancy (HIP) program, a brief motivational intervention featuring a "Video Doctor," provider cueing sheets, and patient educational worksheets, can reduce pregnant women's cigarette smoking, alcohol drinking, illicit drug use, and domestic violence risks compared with usual care.


Condition Intervention
Pregnancy
Behavioral: HIP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Prevention for Prenatal Health: the Health in Pregnancy (HIP) Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Elimination of cigarette smoking, alcohol drinking, and illicit drug use.
  • Reduction in frequency and/or severity of domestic violence.

Secondary Outcome Measures:
  • Patient-provider discussions of risks.
  • Measures of change in cigarette smoking, alcohol drinking, and illicit drug use.

Enrollment: 410
Study Start Date: June 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: HIP
    The Health in Pregnancy (HIP) computer program provides tailored, interactive "Video Doctor" counseling about behavioral risks, educational worksheets for the patients, and a cueing sheet for providers.
Detailed Description:

Regular prenatal visits offer opportunities to deliver and reinforce risk reduction messages regarding tobacco, alcohol, or illicit drug use and domestic violence. Because health care providers may lack the time, comfort, or skills to screen or counsel their patients about these risks, innovative approaches are needed. Computer programs are increasingly used to assess risky behaviors and deliver individualized preventive interventions. We have designed a randomized, controlled trial to determine if a brief, interactive, multimedia intervention delivered on a laptop computer and integrated into routine prenatal care can reduce pregnant women's smoking, drinking, drug use, and experiences of domestic violence compared to usual care. To capitalize on health care providers' credibility, the multimedia intervention is delivered by an actor-portrayed "Video Doctor" programmed to respond to participant input, simulating a live interview. Pregnant women who receive prenatal care at one of the study sites and who consent to participate will be screened for substance use and domestic violence prior to a regularly scheduled medical appointment. Women who report one or more of these risks will be randomly assigned to the Intervention or Control group according to a blocked, stratified randomization plan. Participants in the Intervention group will receive the Health in Pregnancy (HIP) intervention, consisting of brief, multimedia counseling presented by a "Video Doctor" and an educational worksheet. Their provider will receive a "Cueing Sheet," which offers a brief summary of the patient's risk profile and suggests counseling statements. Components of the multimedia program will be tailored to each participant's risk profile and readiness to change. Women assigned to the Control group will complete a risk assessment than receive the usual care offered by the health care settings. Both Intervention and Control participants will complete two follow-up risk assessments at consecutive medical visits approximately four weeks apart. At the first follow-up session, Intervention participants will also receive "booster" risk reduction messages from teh video doctor. To determine the effect of the HIP program on patient-provider discussions, both Intervention and Control participants will complete a post-interview after their medical appointment. The post-interview will also assess the acceptability of the HIP program by participants. To determine the effect of teh program on participants' risky behaviors we will compare self-reported discussions, behavior change, and readiness to change at baseline and at a third session with the computer program. We expect that participants in the Intervention group will show significant reductions in risky behaviors compared to the Control group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or older
  • English speaking
  • Pregnant and receiving prenatal care at a participating study site.

Exclusion Criteria:

  • >25 weeks gestation at baseline session.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540319

Locations
United States, California
Highland Hospital
Oakland, California, United States, 94602
San Francisco General Hospital
San Francisco, California, United States, 94110
St. Luke's Hospital
San Francisco, California, United States, 94110
UCSF Faculty Obstetrics and Gynecology Group
San Francisco, California, United States, 94143
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Barbara Gerbert, PhD University of California, San Francisco
Study Director: Rebecca Jackson, MD San Francisco General Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00540319     History of Changes
Other Study ID Numbers: R01DA15597, R01DA015597
Study First Received: October 4, 2007
Last Updated: August 5, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Risky behaviors
Prenatal care
Substance use
Domestic violence

ClinicalTrials.gov processed this record on October 22, 2014