NCT04098016

Brief Summary

This study will develop a digital intervention ("Healthy Roots") adapted from a previously tested adult digital obesity treatment intervention ("Track").

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

March 1, 2024

Completed
Last Updated

March 1, 2024

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

September 19, 2019

Results QC Date

September 6, 2022

Last Update Submit

August 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intervention Engagement- Number of Text Messages Completed

    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.

    3 months

Secondary Outcomes (1)

  • Change in Healthy Eating Index Score

    Baseline to 3 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Digital Intervention

Interventions

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

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • participating in another related clinical trial;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center - with Piedmont Health Services, Inc.

Durham, North Carolina, 27708, United States

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Dr. Melissa Kay
Organization
Duke University

Study Officials

  • Melissa Kay, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 20, 2019

Study Start

March 8, 2021

Primary Completion

September 22, 2021

Study Completion

September 22, 2021

Last Updated

March 1, 2024

Results First Posted

March 1, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

This is a feasibility trial. There will be no data to share.

Locations