AzTrials
AzTrials

Pregnancy RelatedNCT04298125

Community Translation of the Expecting Study

A study testing Exercise in Pregnancy in people with Pregnancy Related, run by Arkansas Children's Hospital Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy Related
What is being tested?
Exercise in Pregnancy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
16 Jul 2021to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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

Who cannot join

  • (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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arkansas Children's Nutrition Center

    Little Rock, Arkansas, 72205

Other trials in United States

About this study

Official title: Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D

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.

Read the detailed description

The aim of this study is to adapt and determine acceptability, feasibility and fidelity of the research- clinic-based Expecting intervention with pregnant women with obesity in community settings. Specifically, the investigators will show effective application of the Replicating Effective Programs (REP) framework (e.g., fidelity, feasibility, acceptability) to translate the research clinic-based intervention to community settings. REP provides a four-phase process for implementing evidence-based interventions and has demonstrated effective application to translate clinical interventions to community settings. Built into the REP framework is the collection of feedback from community stakeholders, iterative piloting of the intervention in the community, and a process for standardizing the intervention across community settings. Following adaptation, the updated intervention will be piloted. The pilot study will include 60 expecting women. The investigators will randomize half to receive the community-adapted Expecting intervention (Intervention, N=30) and half to receive standard of care (Control, N=30).

Being tested
Exercise in Pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise in PregnancyBehavioural

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

Study groups in NCT04298125
Study groupRoleWhat they receive
Exercise in Pregnancy in CommunityExperimentalThe 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.
Receives: Behavioral: Exercise in Pregnancy
Standard CareNo interventionParticipants will receive guidance on exercise from their physician as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Intervention Measure:38 weeks

    Attitudinal Implementation Outcome on a 1 to 5 scale

    Measured: 38 weeks

  2. Acceptability of Intervention Measure: 38 weeks

    Attitudinal Implementation Outcome on a 1 to 5 scale

    Measured: 38 weeks

Secondary outcomes (5)

  1. Number of intervention sessions completed

    Measured with attendance records

    Measured: 15 weeks through 38 weeks

  2. Number of minutes of physical activity

    Measured with Actical

    Measured: Change from Baseline to Delivery and 6 Months Post Delivery

  3. Body Mass Index

    Collected from Medical Record, weight and height will be combined to report BMI in kg/m^2

    Measured: Change from Baseline to Delivery and 6 Months Post Delivery

  4. Blood Pressure

    Collected from Medical Record

    Measured: Change from Baseline to Delivery and 6 Months Post Delivery

  5. Total Cholesterol from Lipid Panel

    Collected from Medical Record

    Measured: Change from Baseline to Delivery and 6 Months Post Delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2020
  2. Study start16 Jul 2021
  3. Primary completion10 Nov 2025
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04298125
Sponsor's protocol ID
260132
Status last verified
Oct 2026
First submitted
17 Feb 2020
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32895286

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in Pregnancy in people with Pregnancy Related, run by Arkansas Children's Hospital Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Intervention Measure:38 weeks (time frame: 38 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04298125, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in