Digital Intervention To Improve Diet Quality

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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Diet, Healthy
• Intervention / Treatment: Behavioral: Digital Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University Medical Center - with Piedmont Health Services, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training.	Behavioral: Digital Intervention; Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Engagement- Number of Text Messages Completed	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Healthy Eating Index Score	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.	Baseline to 3 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Melissa Kay, PhD, Duke University

Publications and helpful links

General Publications

• Kay MC, Hammad NM, Herring SJ, Bennett GG. Using Interactive Text Messaging to Improve Diet Quality and Increase Redemption of Foods Approved by the Special Supplemental Nutrition Program for Women, Infants, and Children: Protocol for a Cohort Feasibility Study. JMIR Res Protoc. 2021 Dec 15;10(12):e32441. doi: 10.2196/32441.

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pro00102702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a feasibility trial. There will be no data to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No