Skip to main content
OpenTrials
Completed

NCT Number: NCT04098016

Digital Intervention To Improve Diet Quality

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center - with Piedmont Health Services, Inc.

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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;

Treatment and study plan

Digital Intervention

Behavioral

Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.

Primary outcomes

  1. 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

  1. Change in Healthy Eating Index Score

    Time frame: Baseline to 3 months

    The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations of the Dietary Guidelines for Americans (DGA). The scores range from 0 to 100. A higher score reflects greater alignment with key dietary recommendations from the DGA.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2019
Registry last updated
Mar 1, 2024

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.

Published trials that share one or more normalized conditions with this study.