Clinical trial NCT04298125: Community Translation of the Expecting Study
Official title: Antenatal Factors Impacting Obesity and Metabolism in Children: Sub-objective 2D
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

* (a) Body Mass Index \> 30,
* (b) singleton pregnancy,
* (c) between 11-15 weeks of pregnancy (at enrollment),
* (d) sedentary (do not engage in purposeful physical activity plus have sedentary work)
* (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.

Primary outcomes:
measure: Feasibility of Intervention Measure:38 weeks
timeFrame: 38 weeks
measure: Acceptability of Intervention Measure: 38 weeks
timeFrame: 38 weeks
Secondary outcomes:
measure: Number of intervention sessions completed
timeFrame: 15 weeks through 38 weeks
measure: Number of minutes of physical activity
timeFrame: Change from Baseline to Delivery and 6 Months Post Delivery
measure: Body Mass Index
timeFrame: Change from Baseline to Delivery and 6 Months Post Delivery
measure: Blood Pressure
timeFrame: Change from Baseline to Delivery and 6 Months Post Delivery
measure: Total Cholesterol from Lipid Panel
timeFrame: Change from Baseline to Delivery and 6 Months Post Delivery
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
References:
citation: 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.