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Behavioral Intervention

Activity Intervention for Pregnancy Stress (STEP Trial)

N/A

Waitlist Available

Led By Tracy A Manuck, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maternal age 18 to 51 years of age

Ability to communicate in and provide consent in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.

Awards & highlights

STEP Trial Summary

This trial is testing whether a smartphone-based activity intervention using a wrist-based activity tracker can help high risk pregnant women reduce their stress during pregnancy.

Who is the study for?

This trial is for pregnant women at high risk of complications due to obesity or past issues like preeclampsia, with a stress score ≥14. They must be 8-19.9 weeks along in a single pregnancy without abnormalities, aged 18-51, speak English, and own a compatible smartphone.Check my eligibility

What is being tested?

The study tests if using a wrist-based activity tracker and receiving enhanced counseling can reduce stress and improve outcomes during pregnancy compared to standard care. Participants will fill out questionnaires and provide blood samples for analysis.See study design

What are the potential side effects?

There are no direct side effects from the intervention as it involves non-invasive tracking of activity levels. However, participants should consult their doctor if they have conditions that limit physical activity.

STEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman aged between 18 and 51.

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I can communicate and consent in English.

STEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of women with adverse perinatal outcomes

Reduction in Perceived Maternal Stress

Secondary outcome measures

Gestational weight gain

Gestational weight gain, per week after study enrollment

Mean 'Moderate' or greater physical activity

+14 more

STEP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Activity InterventionExperimental Treatment1 Intervention

Women randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. .

Group II: Usual careActive Control1 Intervention

Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Activity Intervention

2014

Completed Phase 2

~90

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,187,412 Total Patients Enrolled

4 Trials studying Pregnancy Complications

13,063 Patients Enrolled for Pregnancy Complications

Tracy A Manuck, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

15 Total Patients Enrolled

1 Trials studying Pregnancy Complications

15 Patients Enrolled for Pregnancy Complications

Media Library

Activity Intervention (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04173559 — N/A

Pregnancy Complications Research Study Groups: Activity Intervention, Usual care

Pregnancy Complications Clinical Trial 2023: Activity Intervention Highlights & Side Effects. Trial Name: NCT04173559 — N/A

Activity Intervention (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04173559 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this clinical investigation?

"Per clinicaltrials.gov, this research project is not currently enrolling participants. It was posted on the 1st of May 2021 and last edited on September 12th 2022; nonetheless, there are four hundred seventy-six other medical studies that require volunteers right now."

Answered by AI

Is this trial amenable to seniors aged 55 and above?

"To be considered for this medical trial, patients must aged between 18 and 51. There are 103 studies specifically targeting minors while 291 clinical trials focus on those over the age of 65."

Answered by AI

What is the objective of this experiment?

"This clinical trial evaluates the ratio of women with adverse perinatal outcomes over a period of 7 months on average. Secondary goals include calculating mean and median daily steps taken, as well as measuring how much 'moderate' or more intense physical activity participants engage in weekly."

Answered by AI

Is participation in this clinical experiment permissible for individuals?

"This clinical trial seeks to recruit 250 pregnant individuals with a record of poor birth outcomes, aged between 18 and 51. Moreover, eligible candidates must be at risk for adverse pregnancy results due to body mass index ≥ 30 kg/m^2 or previous experience of preeclampsia, intrauterine growth restriction or preterm delivery before 37 weeks gestation; in addition to having a perceived stress score over 14 (10-question scale). Furthermore, the gestational age should lay within 8.0 - 19.9 weeks according to American College of Obstetricians and Gynecologists' criteria (utilizing ultrasound tests as well as menstrual dating where"

Answered by AI

Recent research and studies

HypertensionJournal

Recreational Physical Activity During Pregnancy and Risk of Preeclampsia

Sorensen, Tanya K., Michelle A. Williams, I-Min Lee, Edward E. Dashow, Mary Lou Thompson, and David A. Luthy. 2003. “Recreational Physical Activity During Pregnancy and Risk of Preeclampsia”. Hypertension. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.hyp.0000072270.82815.91.

American Journal of Obstetrics and GynecologyJournal

Efficacy of an Intervention to Prevent Excessive Gestational Weight Gain

Olson, Christine M., Myla S. Strawderman, and Roberta G. Reed. 2004. “Efficacy of an Intervention to Prevent Excessive Gestational Weight Gain”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2004.01.027.

Maternal and Child Health JournalJournal

Leisure Time Physical Activity and the Risk of Pre-eclampsia: A Systematic Review

Wolf, H. T., K. M. Owe, M. Juhl, and H. K. Hegaard. 2013. “Leisure Time Physical Activity and the Risk of Pre-eclampsia: A Systematic Review”. Maternal and Child Health Journal. Springer Science and Business Media LLC. doi:10.1007/s10995-013-1316-8.

Cochrane Database of Systematic ReviewsJournal