Digital Intervention To Improve Diet Quality

NCT ID: NCT04098016

Last Updated: 2024-03-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2021-09-22

Brief Summary

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

Detailed Description

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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.

Conditions

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Diet, Healthy Pregnancy Related

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Digital Intervention

Intervention Type BEHAVIORAL

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

Interventions

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Digital Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa Kay, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34914616 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00102702

Identifier Type: -

Identifier Source: org_study_id

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