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Clinical Trials/NCT04098016
NCT04098016
Completed
Not Applicable

Feasibility of Delivering a Digital Behavioral Intervention to Increase Diet Quality Among Women Receiving WIC Benefits

Duke University1 site in 1 country54 target enrollmentMarch 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet, Healthy
Sponsor
Duke University
Enrollment
54
Locations
1
Primary Endpoint
Intervention Engagement- Number of Text Messages Completed
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study will develop a digital intervention ("Healthy Roots") adapted from a previously tested adult digital obesity treatment intervention ("Track").

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. The investigator 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.

Registry
clinicaltrials.gov
Start Date
March 8, 2021
End Date
September 22, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility 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 24 months or younger
  • speaks English as primary language.

Exclusion Criteria

  • participating in another related clinical trial;

Outcomes

Primary Outcomes

Intervention Engagement- Number of Text Messages Completed

Time Frame: 3 months

The average number of text messages completed over the 3-month intervention period. Text messages will be deployed three times a week throughout the 12-week intervention.

Secondary Outcomes

  • Change in Healthy Eating Index Score(Baseline to 3 months)

Study Sites (1)

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