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NCT Number: NCT04298125

Community Translation of the Expecting Study

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72205, United States

Location status: Recruiting

Location contact

Taren M Swindle, PhD

CONTACT

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise in Pregnancy

Behavioral

Women in this group will participate in psychical activity 3 times per week in their community setting.

Primary outcomes

  1. Feasibility of Intervention Measure:38 weeks

    Time frame: 38 weeks

    Attitudinal Implementation Outcome on a 1 to 5 scale

  2. Acceptability of Intervention Measure: 38 weeks

    Time frame: 38 weeks

    Attitudinal Implementation Outcome on a 1 to 5 scale

Secondary outcomes

  1. Number of intervention sessions completed

    Time frame: 15 weeks through 38 weeks

    Measured with attendance records

  2. Number of minutes of physical activity

    Time frame: Change from Baseline to Delivery and 6 Months Post Delivery

    Measured with Actical

  3. Body Mass Index

    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

  4. Blood Pressure

    Time frame: Change from Baseline to Delivery and 6 Months Post Delivery

    Collected from Medical Record

  5. Total Cholesterol from Lipid Panel

    Time frame: Change from Baseline to Delivery and 6 Months Post Delivery

    Collected from Medical Record

Study contacts

Contact information is provided by the study sponsor or research team.

Taren Swindle, PhD

CONTACT

[email protected]

501-526-7058

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2020
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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