Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72205, United States
Location status: Recruiting
Location contact
Taren M Swindle, PhD
CONTACT
NCT Number: NCT04298125
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Little Rock, Arkansas, 72205, United States
Location status: Recruiting
Taren M Swindle, PhD
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women in this group will participate in psychical activity 3 times per week in their community setting.
Time frame: 38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
Time frame: 38 weeks
Attitudinal Implementation Outcome on a 1 to 5 scale
Time frame: 15 weeks through 38 weeks
Measured with attendance records
Time frame: Change from Baseline to Delivery and 6 Months Post Delivery
Measured with Actical
Time frame: 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
Time frame: Change from Baseline to Delivery and 6 Months Post Delivery
Collected from Medical Record
Time frame: Change from Baseline to Delivery and 6 Months Post Delivery
Collected from Medical Record
Contact information is provided by the study sponsor or research team.
Arkansas Children's Hospital Research Institute
Other
Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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