Digital Intervention To Improve Diet Quality

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098016
• Other study ID #: Pro00102702
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: September 22, 2021

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 22, 2021
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Diet, Healthy
• Pregnancy Related

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center - with Piedmont Health Services, Inc.	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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