Clinical trial NCT04098016: Digital Intervention To Improve Diet Quality
Official title: Feasibility of Delivering a Digital Behavioral Intervention to Increase Diet Quality Among Women Receiving WIC Benefits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Pregnancy Related
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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;

Primary outcomes:
measure: Intervention Engagement- Number of Text Messages Completed
timeFrame: 3 months
Secondary outcomes:
measure: Change in Healthy Eating Index Score
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center - with Piedmont Health Services, Inc.
state: North Carolina
Study officials:
affiliation: Duke University
name: Melissa Kay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.