PregnancyHIPNCT00540319
The Health in Pregnancy (HIP) Study
A study testing HIP in people with Pregnancy, run by University of California, San Francisco at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- HIP
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 410 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2006to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- English speaking
- Pregnant and receiving prenatal care at a participating study site.
Who cannot join
- >25 weeks gestation at baseline session.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Highland Hospital
Oakland, California, 94602
San Francisco General Hospital
San Francisco, California, 94110
St. Luke's Hospital
San Francisco, California, 94110
UCSF Faculty Obstetrics and Gynecology Group
San Francisco, California, 94143
Santa Clara Valley Medical Center
San Jose, California, 95128
About this study
Official title: Prevention for Prenatal Health: the Health in Pregnancy (HIP) Study
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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- HIP
- Keywords
- Risky behaviors, Prenatal care, Substance use, Domestic violence
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startJun 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Barbara Gerbert, PhD, Principal investigator, University of California, San FranciscoRebecca Jackson, MD, Study director, San Francisco General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540319
- Sponsor's protocol ID
- R01DA015597
- Other IDs
- R01DA015597
- Acronym
- HIP
- Status last verified
- Aug 2013
- First submitted
- 4 Oct 2007
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention for Prenatal Health: the Health in Pregnancy (HIP) Study
- ClinicalTrials.gov ID
- NCT00540319
- Acronym / sponsor ID
- HIP / R01DA015597
- Conditions
- Pregnancy
- Keywords
- Risky behaviors, Prenatal care, Substance use, Domestic violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- English speaking
- Pregnant and receiving prenatal care at a participating study site.
Key exclusion criteria (1 listed)
- >25 weeks gestation at baseline session.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPThe 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. | Behavioural | – |
Primary outcome
Elimination of cigarette smoking, alcohol drinking, and illicit drug use.
Reduction in frequency and/or severity of domestic violence.
2 secondary outcomes
Patient-provider discussions of risks.
Measures of change in cigarette smoking, alcohol drinking, and illicit drug use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Gerbert, PhD principal investigator
University of California, San Francisco
Rebecca Jackson, MD study director
San Francisco General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIP in people with Pregnancy, run by University of California, San Francisco at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elimination of cigarette smoking, alcohol drinking, and illicit drug use.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.