Randomized Clinical Trial to Increase Physical Activity After a a Hypertensive Pregnancy

NCT04119232 | Completed

• 1 other identifier: 833609
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

STEPUP is a 12-week randomized clinical trial among 126 postpartum women with pregnancies complicated by hypertensive disorders. Participants will be randomized to a control arm and receive a Fitbit or an intervention arm. The intervention arm will receive a Fitbit and set a step count goal, receive daily feedback via text about whether they reached their goal, and will be placed in virtual teams with other participants where they can win points for their team if they meet their daily goals. The main study outcomes will be increase in mean step count and change in psychosocial survey measures.

Conditions

Hypertension in Pregnancy; Preeclampsia; Gestational Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in mean daily steps

  Change in mean daily step count from the baseline period (weeks 1-2) to the intervention period (weeks 3-14)

  weeks 3 to 14 of the intervention

Secondary Outcomes (12)

• Proportion of participant-days that step goals are achieved

  weeks 3 to 14 of the intervention

• Mean daily steps during the 12-week intervention period adjusted for baseline step count

  12-week intervention period

• Change in perceived social support scale

  weeks 3 to 14 of the intervention

• Change in Edinburgh postnatal depression scale (EPDS)

  weeks 3 to 14 of the intervention

• Change in Systolic blood pressure

  weeks 3 to 14 of the intervention

Study Arms (2)

Control

NO INTERVENTION

Individual participants will use a wearable device to monitor daily step counts, set a step goal, and receive automated daily feedback on step goal attainment.

Social incentives-based program

EXPERIMENTAL

Individual participants will use a wearable device to monitor daily step counts, set a step goal, and receive automated daily feedback on step goal attainment. Participants will be placed on a team of 3 randomly assigned participants and receive the social incentives intervention.

Behavioral: Social incentives-based program

Interventions

Social incentives-based program BEHAVIORAL

Individual participants will use a wearable device to monitor daily step counts, set a step goal, and receive automated daily feedback on step goal attainment. Participants will be placed on a team of 3 randomly assigned participants and receive the social incentives intervention.

Social incentives-based program

Eligibility Criteria

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

You may qualify if:

• Delivered a live baby at HUP or PAH within 4.0-12.6 weeks prior to study enrollment;
• Diagnosis of chronic hypertension, gestational hypertension, or preeclampsia during most recent pregnancy;
• Participating in Heart Safe Motherhood (HSM) program;
• Ability to read and provide informed consent to participate in the study;
• Has smartphone and email address

You may not qualify if:

• Does not speak English
• Answers yes to any of the following questions:
• Are you currently participating in any other physical activity studies?
• Do you have any medical conditions or other reasons why you could not participate in a 12-week physical activity program?
• Participants will be excluded after completing the baseline period if their baseline step count is too high (greater than or equal to 10,000 steps per day).

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a two-arm randomized, controlled trial comparing a control group that uses wearable devices to track physical activity to an intervention group that uses the same wearable devices and participates in a team-based model of social incentives that gamifies physical activity. Patients will be randomized to one of the two arms.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 8, 2019
• Study Start: October 10, 2019
• Primary Completion: June 18, 2020
• Study Completion: October 5, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)