Digital Intervention To Improve Diet Quality

Study 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. I 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.

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

Conditions
-----------------
Diet, Healthy, Pregnancy Related

Intervention / Treatment
-----------------
* Behavioral: Digital Intervention


Participation Criteria
=================
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Engagement- Text Completion Rate | The average text message completion rate over the 3-month intervention period | 3-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diet quality | Change in Healthy Eating Index score | Baseline to 3-months |