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Moms on Track Digital Intervention

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ClinicalTrials.gov Identifier: NCT04098016
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study will develop a digital intervention ("Moms on Track") adapted from a previously tested adult digital obesity treatment intervention ("Track").

Condition or disease Intervention/treatment Phase
Diet, Healthy Pregnancy Related Behavioral: Digital Intervention Not Applicable

Detailed Description:
Moms on Track will focus on improving the clinical encounter between WIC clinicians and socioeconomically disadvantaged mothers, who are disproportionately impacted by obesity, during the first 6 months postpartum. The proposed trial will test the feasibility of mothers receiving WIC benefits to participate in a pilot digital behavioral intervention to increase diet quality, which will deliver nutrition guidance for meeting recommendations outlined in the Dietary Guidelines for Americans using interactive self-monitoring and feedback, and tailored skills training. I will also explore acceptability of participating in Moms on Track among both mothers receiving WIC benefits and WIC clinicians who are delivering counseling. This will help determine the potential for this intervention to be implemented into the existing clinical WIC encounter.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Feasibility of Delivering a Digital Behavioral Intervention to Increase Diet Quality Among Women Receiving WIC Benefits
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Arm Intervention/treatment
Experimental: Intervention
Participants (N=50) will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) responsive coaching, and 4) skills training.
Behavioral: Digital Intervention
Participants (N=50) will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) responsive coaching, and 4) skills training.




Primary Outcome Measures :
  1. Intervention Engagement- Text Completion Rate [ Time Frame: 3-months ]
    The average text message completion rate over the 3-month intervention period

  2. Intervention Engagement- Coach Calls Completed [ Time Frame: 3-months ]
    The average number of coaching calls compled

  3. Intervention Engagement- Coach Call Duration [ Time Frame: 3-months ]
    The average duration of completed coaching calls



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥18 years;
  • Has a smartphone with a data plan and an email address;
  • willing to receive daily text messages;
  • speaks English as primary language.

Exclusion Criteria:

  • participating in another related clinical trial;
  • planning to leave the area during
  • study time period; documented dementia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098016


Contacts
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Contact: Melissa Kay, PhD (919) 684-1953 melissa.kay@duke.edu
Contact: Jamiyla Bolton-Cubillan 919-613-5456 jamiyla.bolton@duke.edu

Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Melissa Kay, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04098016     History of Changes
Other Study ID Numbers: Pro00102702
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a feasibility trial. There will be no data to share.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No