Life StressNCT01997151
Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention
A study testing Healthy Pregnancy: Step by Step in people with Life Stress and Smoking Cessation, run by Pro-Change Behavior Systems.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Life Stress, Smoking Cessation, Poor Nutrition
- What is being tested?
- Healthy Pregnancy: Step by Step
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Aug 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Speak and read either English or Spanish
- Consent to the research.
Who cannot join
- More than 18 weeks gestation
About this study
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.
Read the detailed description
Promoting health behaviors during pregnancy has tremendous public health significance. Poor health behaviors are associated with pregnancy complications, birth outcomes, and the health of the child. They influence infant birthweight, premature birth, and infant mortality rates, all of which continue to be public health concerns, reflected in the goals of Healthy People 2020.
Pregnant women, particularly those from under-served populations, often have a multitude of health behavior risks that threaten positive pregnancy and birth outcomes, as well as the future health of mother and baby. Pregnancy offers a window of opportunity for behavioral intervention. The immediate health risk for the baby motivates most pregnant women to at least consider changing their behavior. Furthermore, the regular and continual medical care that most pregnant women receive allows optimal access for intervention. The circumstance of pregnancy can be used as a teachable moment to better the future health of women and children.
The primary goals of this study were to complete and enhance the development of an iPad delivered intervention and to assess the efficacy in a randomized clinical trial involving pregnant women from three federally-funded community health centers that treat under-served populations. Using interactive technology, users complete onscreen assessments and receive individually tailored feedback messages on key behavior change strategies identified by the Transtheoretical Model of Behavior Change and matched to their stage of readiness for each behavior. Supplemental intervention components were created including printed feedback reports, a multiple behavior stage-based manual, and Spanish versions of all intervention materials. This intervention offers a cost-effective, science based, and easily deliverable solution to improve multiple health behaviors, and overall health and well-being, of populations of pregnant women.
- Conditions
- Life Stress, Smoking Cessation, Poor Nutrition
- Being tested
- Healthy Pregnancy: Step by Step
- Medical subject headings
- Stress, Psychological, Smoking Cessation, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Pregnancy: Step by StepBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Healthy Pregnancy: Step by Step | Experimental | Pregnant women interacted with a multiple behavior change iPad- delivered program at federally funded health centers. The 20-30 minute program offered onscreen assessments of Transtheoretical Model strategies of change, and then provided individually tailored feedback messages matched to their readiness to change for relevant target behaviors. The program addressed smoking cessation and relapse prevention, stress management, and fruit and vegetable consumption. The feedback screens were interactive and engaging. The messages were written at a 4th-5th grade level and were reviewed for multicultural relevancy. Participants in the treatment group interacted with the program up to 3 times during pregnancy. A printed multiple behavior change guide also was distributed. All program components are available in English and Spanish. Receives: Behavioral: Healthy Pregnancy: Step by Step |
| Usual Care | No intervention | Pregnant women received regular prenatal care as delivered by the health care center from where they were receiving care. Standard informational March of Dimes brochures related to the target behaviors were distributed to usual care participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
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
Measured: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
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
Measured: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
Secondary outcomes (2)
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.
Measured: Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery
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.
Measured: Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Life StressStudies of the same condition, open and under way.
- 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
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pro-Change Behavior Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leanne Mauriello, Pro-Change Behavior Systems
- Investigators
- Leanne D Mauriello, Ph.D., Principal investigator, Pro-Change Behavior Systems Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997151
- Sponsor's protocol ID
- GRANT10236132
- Other IDs
- 5R44DP001115-03
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21323854Prochaska JM, Mauriello L, Dyment S, Gokbayrak 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.
PubMed 22092465Mauriello LM, Van Marter DF, Umanzor CD, Castle PH, de Aguiar EL. Using mHealth to Deliver Behavior Change Interventions Within Prenatal Care at Community Health Centers. Am J Health Promot. 2016 Sep;30(7):554-62. doi: 10.4278/ajhp.140530-QUAN-248. Epub 2016 Jun 16.
PubMed 26305603
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention
- ClinicalTrials.gov ID
- NCT01997151
- Acronym / sponsor ID
- GRANT10236132
- Conditions
- Life Stress, Smoking Cessation, Poor Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Pro-Change Behavior SystemsUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 27 Nov 2013 (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.
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.
Detailed description
Promoting health behaviors during pregnancy has tremendous public health significance. Poor health behaviors are associated with pregnancy complications, birth outcomes, and the health of the child. They influence infant birthweight, premature birth, and infant mortality rates, all of which continue to be public health concerns, reflected in the goals of Healthy People 2020.
Pregnant women, particularly those from under-served populations, often have a multitude of health behavior risks that threaten positive pregnancy and birth outcomes, as well as the future health of mother and baby. Pregnancy offers a window of opportunity for behavioral intervention. The immediate health risk for the baby motivates most pregnant women to at least consider changing their behavior. Furthermore, the regular and continual medical care that most pregnant women receive allows optimal access for intervention. The circumstance of pregnancy can be used as a teachable moment to better the future health of women and children.
The primary goals of this study were to complete and enhance the development of an iPad delivered intervention and to assess the efficacy in a randomized clinical trial involving pregnant women from three federally-funded community health centers that treat under-served populations. Using interactive technology, users complete onscreen assessments and receive individually tailored feedback messages on key behavior change strategies identified by the Transtheoretical Model of Behavior Change and matched to their stage of readiness for each behavior. Supplemental intervention components were created including printed feedback reports, a multiple behavior stage-based manual, and Spanish versions of all intervention materials. This intervention offers a cost-effective, science based, and easily deliverable solution to improve multiple health behaviors, and overall health and well-being, of populations of pregnant women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Pregnancy: Step by Step | Experimental | Behavioral: Healthy Pregnancy: Step by StepPregnant women interacted with a multiple behavior change iPad- delivered program at federally funded health centers. The 20-30 minute program offered onscreen assessments of Transtheoretical Model strategies of change, and then provided individually tailored feedback messages matched to their readiness to change for relevant target behaviors. The program addressed smoking cessation and relapse prevention, stress management, and fruit and vegetable consumption. The feedback screens were interactive and engaging. The messages were written at a 4th-5th grade level and were reviewed for multicultural relevancy. Participants in the treatment group interacted with the program up to 3 times during pregnancy. A printed multiple behavior change guide also was distributed. All program components are available in English and Spanish. |
| Usual Care | No intervention | –Pregnant women received regular prenatal care as delivered by the health care center from where they were receiving care. Standard informational March of Dimes brochures related to the target behaviors were distributed to usual care participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old
- Speak and read either English or Spanish
- Consent to the research.
Key exclusion criteria (1 listed)
- More than 18 weeks gestation
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 |
|---|---|---|
| Healthy Pregnancy: Step by Step | Behavioural | Healthy Pregnancy: Step by Step |
Primary outcome
Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery
Time frame: Third trimester of pregnancy, 1 month post delivery, 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).
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
Time frame: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
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
Time frame: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
2 secondary outcomes
Proportion who progress to the action criteria for effectively managing stress (at baseline not meeting criteria)
Time frame: Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery
Proportion who progress to the action criteria for eating enough fruits and vegetables (at baseline not meeting criteria)
Time frame: Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery
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 27 Nov 2013.
- Background: PubMed 21323854Mauriello 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.
- Background: PubMed 22092465Prochaska JM, Mauriello L, Dyment S, Gokbayrak 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.
- Derived from this study: PubMed 26305603Mauriello LM, Van Marter DF, Umanzor CD, Castle PH, de Aguiar EL. Using mHealth to Deliver Behavior Change Interventions Within Prenatal Care at Community Health Centers. Am J Health Promot. 2016 Sep;30(7):554-62. doi: 10.4278/ajhp.140530-QUAN-248. Epub 2016 Jun 16.
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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.
Leanne D Mauriello, Ph.D. principal investigator
Pro-Change Behavior Systems Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Pregnancy: Step by Step in people with Life Stress and Smoking Cessation, run by Pro-Change Behavior Systems.
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 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery (time frame: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997151, which also lists 3 linked publications.
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 27 Nov 2013.