Recruiting

Observational Study

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT04298125

Conditions

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise in Pregnancy

Study Details

Brief summary:

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.

Conditions

Pregnancy Related

Study ID

NCT04298125

Start date

Jul 16, 2021

Status verified date

Sep, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • (a) Body Mass Index > 30,
  • (b) singleton pregnancy,
  • (c) between 11-15 weeks of pregnancy (at enrollment),
  • (d) Do not currently meet recommended guidelines of 150 min of activity per week
  • (e) cleared by physician

Exclusion Criteria:

  • (a) contraindications for exercise (preeclampsia-eclampsia, premature rupture of the membranes, antepartum hemorrhage, placenta previa, multiple gestation and other defined conditions)
  • (b) illicit drug use.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Exercise in Pregnancy

Women in this group will participate in psychical activity 3 times per week in their community setting.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Taren Swindle, PhD

501-526-7058tswindle@uams.edu

Locations

Arkansas Children's Nutrition Center

Recruiting

Little Rock, Arkansas, United States, 72205

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2025-10-02.