Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
54 participants
INTERVENTIONAL
2021-03-08
2021-09-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Targeted Lifestyle Change Group Prenatal Care
NCT04090307
Lifestyle Interventions for Long Term Diabetes Control
NCT00364312
HOPE Intervention for Fitness
NCT07114822
Whole Prediabetes: A Family-Centered Whole Foods Diet in Adults With Prediabetes and Their Offspring
NCT05483972
Avoiding Diabetes After Pregnancy Trial in Moms
NCT01918345
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training.
Digital Intervention
Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Digital Intervention
Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Melissa Kay, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke University Medical Center - with Piedmont Health Services, Inc.
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00102702
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.