- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07718646
Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity
A Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity: a CBT-informed Pilot Study
Study Overview
Detailed Description
This is a single-arm pilot study enrolling mothers experiencing food insecurity. Because this is a pilot feasibility study, no comparison group is included. Eligible participants will complete baseline assessments before beginning the intervention, including measures of food security, mental health symptoms, coping strategies, and related psychosocial factors. Participants will then complete an eight-week fully mHealth-based intervention using the Univeristy of Oklahoma Insight mHealth mobile application.
Throughout the intervention, participants will receive 3 daily messages focused on building coping skills, managing stress, and supporting mental well-being. The app includes educational modules, goal-setting activities, coping exercises, daily check-ins, and supportive messages. Participants will engage with the app at their own pace and will receive brief assessments and messages throughout the intervention period.
After completing the eight-week intervention, participants will complete post-intervention assessments to evaluate changes in mental health, coping, and intervention acceptability and feasibility. A subset of participants will also be invited to complete a follow-up interview to provide feedback on their experiences using the app, including facilitators and barriers to engagement.
This pilot study will provide preliminary information on the feasibility, acceptability, and potential efficacy of a cognitive behavioral therapy-informed mHealth intervention to support mental health among mothers experiencing food insecurity.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rachel Liebe
- Phone Number: 405-744-5043
- Email: rachel.liebe@okstate.edu
Study Locations
-
-
Oklahoma
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Stillwater, Oklahoma, United States, 74078
- Recruiting
- Oklahoma State University
-
Contact:
- Rachel Liebe
- Phone Number: 405-744-5043
- Email: rachel.liebe@okstate.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Reside in Oklahoma
- Identify as a woman or non-binary
- At least 18 years old
- Have a child under 18 years old living in your household
- Experienced food insecurity in the past 30 days
Exclusion Criteria:
- Currently undergoing mental health counseling
- No access to a smartphone (Apple or Android)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mHealth app
Mobile phone-delivered content focused on building coping skills, managing stress, and supporting mental well-being among mothers experiencing food insecurity.
|
An 8-week behavioral intervention delivered through a mobile application that combines multiple behavior change techniques, including coping education, self-monitoring, goal setting, and skill-building reflections The intervention is designed to help participants develop and practice coping strategies to manage stress and improve mental well-being.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment feasibility
Time Frame: Evaluated throughout recruitment and at completion of the recruitment period
|
Percentage (%) of eligible individuals who enroll in the study among all individuals determined eligible through the screening survey.
Higher percentages indicate greater recruitment feasibility.
|
Evaluated throughout recruitment and at completion of the recruitment period
|
|
Intervention retention
Time Frame: Measured from enrollment through completion of post-intervention data collection (8 weeks)
|
Percentage (%) of enrolled participants who complete the post-intervention assessment.
Higher percentages indicate greater retention.
|
Measured from enrollment through completion of post-intervention data collection (8 weeks)
|
|
App Engagement
Time Frame: Measured throughout the 8-week intervention period
|
Intervention engagement assessed using Insight application analytics, including number of intervention messages opened, number of weekly goal-setting activities completed, and interactions with intervention content.
Greater values indicate higher engagement.
|
Measured throughout the 8-week intervention period
|
|
Usability
Time Frame: Measured at post-intervention (8 weeks)
|
Systems Usability Scale (SUS) total score (range 0-100).
Higher scores indicate greater usability; scores >68 indicate above-average usability.
|
Measured at post-intervention (8 weeks)
|
|
Participant Acceptability
Time Frame: Measured at post-intervention (8 weeks)
|
Program satisfaction assessed using investigator-developed 5-point Likert-scale items evaluating intervention acceptability.
Mean scores range from 1-5, with higher scores indicate greater acceptability.
|
Measured at post-intervention (8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food Security Status
Time Frame: Measured at baseline and post intervention (8 weeks)
|
USDA 18-item Household Food Security Survey Module (HFSSM) raw score assessing household, adult, and child food security over the previous 30 days.
Scores range from 0-18, with higher scores indicate greater food insecurity.
|
Measured at baseline and post intervention (8 weeks)
|
|
Cognitive Functioning
Time Frame: Measured at baseline and post intervention (8 weeks)
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function Short Form and PROMIS Cognitive Function Abilities Short Form 6a T-scores assessing perceived cognitive functioning.
T scores have an average of 50, and 10 is one standard deviation.
Higher scores indicate better cognitive functioning.
|
Measured at baseline and post intervention (8 weeks)
|
|
Anxiety Symptoms
Time Frame: Measured at baseline and post intervention (8 weeks)
|
Generalized Anxiety Disorder-7 (GAD-7) total score (range 0-21).
Higher scores indicate greater anxiety symptom severity.
|
Measured at baseline and post intervention (8 weeks)
|
|
Depressive Symptoms
Time Frame: Measured at baseline and post intervention (8 weeks)
|
Patient Health Questionnaire-9 (PHQ-9) total score (range 0-27).
Higher scores indicate greater depressive symptom severity.
|
Measured at baseline and post intervention (8 weeks)
|
|
Coping Behaviors
Time Frame: Measured at baseline and post intervention (8 weeks)
|
Brief Coping Orientation to Problems Experienced Inventory (Brief COPE) questionnaire scores assessing coping quantity and coping style.
Scores are calculated according to the Brief COPE scoring protocol; higher scores indicate greater use of each coping strategy.
Mean scores range from 1 to 4.
|
Measured at baseline and post intervention (8 weeks)
|
|
Diet Quality
Time Frame: Measured at baseline and post intervention (8 weeks)
|
Healthy Eating Index (HEI-2015) score are the output from the National Cancer Institute Diet History Questionnaire III (DHQ III) survey.
Higher scores indicate better overall diet quality (score range: 0-100).
|
Measured at baseline and post intervention (8 weeks)
|
|
Food resource management
Time Frame: Measured at baseline and post-intervention (8 weeks).
|
A subset of problem-focused coping, food resource management, will be assessed with an adapted version of items from the Expanded Food and Nutrition Education Program (EFNEP) questionnaire.
Scores range from Never (0) to Always (5), with higher mean scores indicating more food resource management behaviors.
|
Measured at baseline and post-intervention (8 weeks).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-26-160
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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