Diet, Healthy, Pregnancy Related
Conditions
Brief summary
This study will develop a digital intervention (Healthy Roots) adapted from a previously tested adult digital obesity treatment intervention (Track).
Detailed description
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.
Interventions
BEHAVIORALDigital Intervention
Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Engagement- Number of Text Messages Completed | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Healthy Eating Index Score | Baseline to 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| Total | 54 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 31.1 years STANDARD_DEVIATION 7.7 |
| Healthy Eating Index-2015 score | 49.7 units on a scale STANDARD_DEVIATION 12.4 |
| Race/Ethnicity, Customized Did not respond | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 14 Participants |
| Race/Ethnicity, Customized Non-Hispanic two or more races | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 34 Participants |
| Region of Enrollment United States | 54 Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 3 months
Population: Only applicable to the intervention group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Intervention Engagement- Number of Text Messages Completed | 7.4 text messages | Standard Deviation 4.6 |
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.
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Healthy Eating Index Score | 0.8 score on a scale | Standard Deviation 12.9 |