Community Translation of the Expecting Study

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Pregnancy Related

Intervention / Treatment
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* Behavioral: Exercise in Pregnancy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise in Pregnancy in Community<br>The 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. | Behavioral: Exercise in Pregnancy<br>* Women in this group will participate in psychical activity 3 times per week in their community setting.<br>|
| No Intervention: Standard Care<br>Participants will receive guidance on exercise from their physician as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Intervention Measure:38 weeks | Attitudinal Implementation Outcome on a 1 to 5 scale | 38 weeks | 
| Acceptability of Intervention Measure: 38 weeks | Attitudinal Implementation Outcome on a 1 to 5 scale | 38 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intervention sessions completed | Measured with attendance records | 15 weeks through 38 weeks | 
| Number of minutes of physical activity | Measured with Actical | Change from Baseline to Delivery and 6 Months Post Delivery | 
| Body Mass Index | Collected from Medical Record, weight and height will be combined to report BMI in kg/m^2 | Change from Baseline to Delivery and 6 Months Post Delivery | 
| Blood Pressure | Collected from Medical Record | Change from Baseline to Delivery and 6 Months Post Delivery | 
| Total Cholesterol from Lipid Panel | Collected from Medical Record | Change from Baseline to Delivery and 6 Months Post Delivery |