Smoking Cessation Clinical Trial
Official title:
Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention
Verified date | November 2013 |
Source | Pro-Change Behavior Systems |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This program of research tested the effectiveness of an iPad delivered multiple behavior intervention grounded in the Transtheoretical Model of Behavior Change for pregnant women. It was hypothesized that the intervention would reduce the number of health behavior risks reported by pregnant women in the treatment group. The target behaviors of the intervention are smoking cessation and relapse prevention, stress management, and fruit and vegetable consumption.
Status | Completed |
Enrollment | 374 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - At least 18 years old - Speak and read either English or Spanish - Consent to the research. Exclusion Criteria: - More than 18 weeks gestation |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pro-Change Behavior Systems |
Mauriello L, Dyment S, Prochaska J, Gagliardi A, Weingrad-Smith J. Acceptability and feasibility of a multiple-behavior, computer-tailored intervention for underserved pregnant women. J Midwifery Womens Health. 2011 Jan-Feb;56(1):75-80. doi: 10.1111/j.1542-2011.2010.00007.x. — View Citation
Prochaska JM, Mauriello L, Dyment S, Gökbayrak S. Designing a health behavior change program for dissemination to underserved pregnant women. Public Health Nurs. 2011 Nov-Dec;28(6):548-55. doi: 10.1111/j.1525-1446.2011.00959.x. Epub 2011 Aug 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery | Health risks were defined as not meeting criteria for smoking (not smoking), fruit and vegetable consumption (eating at least 5 servings a day), and stress management (effectively managing stress). | Third trimester of pregnancy, 1 month post delivery, 4 months post delivery | No |
Primary | Change in number of minutes spent on stress management each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery | Third trimester of pregnancy, 1 month post delivery, 4 months post delivery | No | |
Primary | Change in number of servings of fruits and vegetables consumed each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery | Third trimester of pregnancy, 1 month post delivery, 4 months post delivery | No | |
Secondary | Proportion who progress to the action criteria for effectively managing stress (at baseline not meeting criteria) | Assessed by readiness to effectively manage stress each day. | Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery | No |
Secondary | Proportion who progress to the action criteria for eating enough fruits and vegetables (at baseline not meeting criteria) | Assessed by readiness to eat at least 5 servings of fruits and vegetables each day. | Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery | No |
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