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This study will develop a digital intervention ("Healthy Roots") adapted from a previously tested adult digital obesity treatment intervention ("Track").
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, and 3) skills training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Intervention | Behavioral | Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Healthy Eating Index Score | The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations of the Dietary Guidelines for Americans (DGA). The scores range from 0 to 100. A higher score reflects greater alignment with key dietary recommendations from the DGA. | Baseline to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Kay, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center - with Piedmont Health Services, Inc. | Durham | North Carolina | 27708 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34914616 | Derived | 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. |
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This is a feasibility trial. There will be no data to share.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only applicable to the intervention group. | Posted | Mean | Standard Deviation | text messages | 3 months |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Kay | Duke University | 7812493062 | melissa.kay@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 13, 2021 | Aug 29, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2021 | Aug 29, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 16, 2021 | Aug 20, 2021 | ICF_000.pdf |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Healthy Eating Index-2015 score | The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations of the Dietary Guidelines for Americans (DGA). The scores range from 0 to 100. A higher score reflects greater alignment with key dietary recommendations from the DGA. | Mean | Standard Deviation | units on a scale |
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| Units |
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| Participants |
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| Secondary | Change in Healthy Eating Index Score | The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations of the Dietary Guidelines for Americans (DGA). The scores range from 0 to 100. A higher score reflects greater alignment with key dietary recommendations from the DGA. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3 months |
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