NCT00540319

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
410

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Jun 2006

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

1.1 years

First QC Date

October 4, 2007

Last Update Submit

August 5, 2013

Conditions

Keywords

Risky behaviorsPrenatal careSubstance useDomestic violence

Outcome Measures

Primary Outcomes (2)

  • Elimination of cigarette smoking, alcohol drinking, and illicit drug use.

  • Reduction in frequency and/or severity of domestic violence.

Secondary Outcomes (2)

  • Patient-provider discussions of risks.

  • Measures of change in cigarette smoking, alcohol drinking, and illicit drug use.

Interventions

HIPBEHAVIORAL

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \>25 weeks gestation at baseline session.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Highland Hospital

Oakland, California, 94602, United States

Location

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

St. Luke's Hospital

San Francisco, California, 94110, United States

Location

UCSF Faculty Obstetrics and Gynecology Group

San Francisco, California, 94143, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Barbara Gerbert, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR
  • Rebecca Jackson, MD

    San Francisco General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 8, 2007

Study Start

June 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

August 7, 2013

Record last verified: 2013-08

Locations