Community Translation of the Expecting Study

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Arkansas Children's Hospital Research Institute
Study ID
NCT04298125
Status
Recruiting
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Conditions

  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise in Pregnancy — BEHAVIORAL
    Women in this group will participate in psychical activity 3 times per week in their community setting.

Study Details

The Expecting intervention as delivered in prior studies in a clinical setting is described in a previous approved IRB submission (Protocol 202954). The current project will seek to engage community stakeholders to translate Expecting to a community-delivered intervention and to test its acceptability, feasibility, and fidelity in a proof of principle study with 60 expecting mothers.

Key Dates

Start date
Jul 16, 2021
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Exercise in Pregnancy in Community
    The Expecting intervention at the ACNC includes three 30-45 minute, in-person exercise sessions per week. The sessions are gradually increased in length over the first weeks of participation, and are comprised of 15-30 minutes of moderate aerobic activity (recumbent bike, walking on a treadmill or on an elliptical machine) as well as 5-10 minutes of resistance training using hydraulic exercise equipment. The sessions conclude with stretching exercises. Throughout the session, a personal trainer assesses the rating of perceived exertion using the 6 to 20 point Borg scale of exhaustion.41 Between sessions, participants are asked to monitor their daily step count with a target of 10,000 steps per day using a pedometer provided to the participant. This number is reported to or downloaded by the personal trainer at each in-person session. These elements will be adapted to provide a similar exercise experience that is accessible to women in their local community.
  • No Intervention: Standard Care
    Participants will receive guidance on exercise from their physician as usual.

Primary Outcome Measure

Feasibility of Intervention Measure:38 weeks [ Time Frame: 38 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arkansas Children's Nutrition CenterLittle RockArkansas72205
Taren M Swindle, PhD

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