Community Translation of the Expecting Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Behavioral: Exercise in Pregnancy

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taren Swindle, PhD; Phone Number: 501-526-7058; Email: tswindle@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • Arkansas Children's Nutrition Center
      • Contact: Taren M Swindle, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 260132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No