NCT04298125

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jul 2021Jun 2026

First Submitted

Initial submission to the registry

February 17, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 16, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

4.9 years

First QC Date

February 17, 2020

Last Update Submit

September 29, 2025

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Intervention Measure:38 weeks

    Attitudinal Implementation Outcome on a 1 to 5 scale

    38 weeks

  • Acceptability of Intervention Measure: 38 weeks

    Attitudinal Implementation Outcome on a 1 to 5 scale

    38 weeks

Secondary Outcomes (5)

  • Number of intervention sessions completed

    15 weeks through 38 weeks

  • Number of minutes of physical activity

    Change from Baseline to Delivery and 6 Months Post Delivery

  • Body Mass Index

    Change from Baseline to Delivery and 6 Months Post Delivery

  • Blood Pressure

    Change from Baseline to Delivery and 6 Months Post Delivery

  • Total Cholesterol from Lipid Panel

    Change from Baseline to Delivery and 6 Months Post Delivery

Study Arms (2)

Exercise in Pregnancy in Community

EXPERIMENTAL

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.

Behavioral: Exercise in Pregnancy

Standard Care

NO INTERVENTION

Participants will receive guidance on exercise from their physician as usual.

Interventions

Exercise in PregnancyBEHAVIORAL

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

Exercise in Pregnancy in Community

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis intervention only targets pregnant individuals, which is likely to exclude those who identify as male.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72205, United States

RECRUITING

Related Publications (1)

  • Swindle T, Martinez A, Borsheim E, Andres A. Adaptation of an exercise intervention for pregnant women to community-based delivery: a study protocol. BMJ Open. 2020 Sep 6;10(9):e038582. doi: 10.1136/bmjopen-2020-038582.

    PMID: 32895286DERIVED

MeSH Terms

Interventions

ExercisePregnancy

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Central Study Contacts

Taren Swindle, PhD

CONTACT

501-526-7058tswindle@uams.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

March 6, 2020

Study Start

July 16, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)