Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

NCT01997151 | Completed

• 2 other identifiers: GRANT102361325R44DP001115-03
• Study Type: interventional
• Target: 374
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Life Stress; Smoking Cessation; Poor Nutrition

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Proportion who progress to the action criteria for effectively managing stress (at baseline not meeting criteria)

  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)

  Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery

Study Arms (2)

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.

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.

Interventions

Healthy Pregnancy: Step by Step BEHAVIORAL

Healthy Pregnancy: Step by Step

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Speak and read either English or Spanish
• Consent to the research.

You may not qualify if:

• More than 18 weeks gestation

Sponsors & Collaborators

• Pro-Change Behavior Systems: lead

Related Publications (3)

• 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.

  PMID: 21323854 BACKGROUND

• Prochaska 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.

  PMID: 22092465 BACKGROUND

• Mauriello 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.

  PMID: 26305603 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Smoking Cessation; Malnutrition

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Health Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Leanne D Mauriello, Ph.D.

  Pro-Change Behavior Systems Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Research and Product Development

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: December 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11