Digital Intervention To Improve Diet Quality

Not Applicable

Completed

• Conditions: Diet, Healthy; Pregnancy Related
• Interventions: Behavioral: Digital Intervention

• Registration Number: NCT04098016
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Study Start: 2021-03-08
• Primary Completion: 2021-09-22
• Study Completion: 2021-09-22
• Results First Submitted: 2022-09-06
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Results First Posted: 2024-03-01
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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.

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Exclusion Criteria

• participating in another related clinical trial;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Intervention Engagement- Number of Text Messages Completed	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 Outcome Measures

Name	Time	Method
Change in Healthy Eating Index Score	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.

Trial Locations

Locations (1)

Duke University Medical Center - with Piedmont Health Services, Inc.; 🇺🇸 Durham, North Carolina, United States