Digital Intervention To Improve Diet Quality
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|ClinicalTrials.gov Identifier: NCT04098016|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2019
Last Update Posted : August 31, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diet, Healthy Pregnancy Related||Behavioral: Digital Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Delivering a Digital Behavioral Intervention to Increase Diet Quality Among Women Receiving WIC Benefits|
|Actual Study Start Date :||March 8, 2021|
|Estimated Primary Completion Date :||September 29, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
- Intervention Engagement- Text Completion Rate [ Time Frame: 3-months ]The average text message completion rate over the 3-month intervention period
- Diet quality [ Time Frame: Baseline to 3-months ]Change in Healthy Eating Index score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098016
|United States, North Carolina|
|Duke University Medical Center - with Piedmont Health Services, Inc.|
|Durham, North Carolina, United States, 27708|
|Principal Investigator:||Melissa Kay, PhD||Duke University|