Community Translation of the Expecting Study
ConditionPregnancy Related
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorArkansas Children's Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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
Disqualifiers
(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 design
Design model
Parallel
Treatments tested in this trial
Exercise in Pregnancy
BehavioralWomen in this group will participate in psychical activity 3 times per week in their community setting.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Exercise in Pregnancy in CommunityExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility of Intervention Measure:38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
Time frame
38 weeks2
Acceptability of Intervention Measure: 38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
Time frame
38 weeksSecondary outcomes
1
Number of intervention sessions completed
Measured with attendance records
Time frame
15 weeks through 38 weeks2
Number of minutes of physical activity
Measured with Actical
Time frame
Change from Baseline to Delivery and 6 Months Post Delivery3
Body Mass Index
Collected from Medical Record, weight and height will be combined to report BMI in kg/m\^2
Time frame
Change from Baseline to Delivery and 6 Months Post Delivery4
Blood Pressure
Collected from Medical Record
Time frame
Change from Baseline to Delivery and 6 Months Post DeliverySponsors and contacts
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Source ClinicalTrials.gov