Pregnancy Related
Conditions
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.
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).
Interventions
BEHAVIORALExercise in Pregnancy
Women in this group will participate in psychical activity 3 times per week in their community setting.
Sponsors
Arkansas Children's Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure:38 weeks | 38 weeks | Attitudinal Implementation Outcome on a 1 to 5 scale |
| Acceptability of Intervention Measure: 38 weeks | 38 weeks | Attitudinal Implementation Outcome on a 1 to 5 scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Change from Baseline to Delivery and 6 Months Post Delivery | Collected from Medical Record, weight and height will be combined to report BMI in kg/m\^2 |
| Number of intervention sessions completed | 15 weeks through 38 weeks | Measured with attendance records |
| Total Cholesterol from Lipid Panel | Change from Baseline to Delivery and 6 Months Post Delivery | Collected from Medical Record |
| Blood Pressure | Change from Baseline to Delivery and 6 Months Post Delivery | Collected from Medical Record |
| Number of minutes of physical activity | Change from Baseline to Delivery and 6 Months Post Delivery | Measured with Actical |
Countries
United States
Contacts
Primary ContactTaren Swindle, PhD
Outcome results
None listed