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Healthy Roots Digital Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098016
Recruitment Status : Suspended (Aim 1 enrollment and study activities have been completed. Aim 2 start date is now anticipated for 01/11/2021.)
First Posted : September 20, 2019
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study will develop a digital intervention ("Healthy Roots") 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:

Healthy Roots 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.

Prior to the clinical trial portion of this project, quantitative interviews (Aim 1) were held to explore how digital health tools can be use to improve the dietary patterns of mothers and caregivers during the early postpartum period. 13 individuals who receive WIC benefits from Piedmont Health Services will be asked to participate in a one-time interview with research staff.

Following quantitative interviews, the proposed trial (Aims 2 and 3) 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 Healthy Roots 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
Allocation: N/A
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 : January 11, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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


Secondary Outcome Measures :
  1. Diet quality [ Time Frame: Baseline to 3-months ]
    Change in Healthy Eating Index score



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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;
  • receives WIC benefits from Piedmont Health Services (North Carolina)
  • has a child that is 2 years old or younger
  • speaks English or Spanish 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


Locations
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United States, North Carolina
Duke University Medical Center - with Piedmont Health Services, Inc.
Durham, North Carolina, United States, 27708
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    
Other Study ID Numbers: Pro00102702
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: January 2020
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