An interventional study of MOMent in Food Insecurity, sponsored by Oklahoma State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Oklahoma State University · Not applicable, Interventional, and Prevention
This is a pilot study testing a mobile app that is designed to help mothers experiencing food insecurity manage stress and build coping skills. Participants will use the app for 8 weeks and complete surveys about their experiences, mental health, and coping. The study will help us learn whether the app is helpful and feasible for future research.
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.
Exclusion Criteria:
Mobile phone-delivered content focused on building coping skills, managing stress, and supporting mental well-being among mothers experiencing food insecurity.
Behavioral: MOMent
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.
Recruitment feasibility
Percentage (%) of eligible individuals who enroll in the study among all individuals determined eligible through the screening survey. Higher percentages indicate greater recruitment feasibility.
Time frame: Evaluated throughout recruitment and at completion of the recruitment period
Intervention retention
Percentage (%) of enrolled participants who complete the post-intervention assessment. Higher percentages indicate greater retention.
Time frame: Measured from enrollment through completion of post-intervention data collection (8 weeks)
App Engagement
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.
Time frame: Measured throughout the 8-week intervention period
Usability
Systems Usability Scale (SUS) total score (range 0-100). Higher scores indicate greater usability; scores \>68 indicate above-average usability.
Time frame: Measured at post-intervention (8 weeks)
Participant Acceptability
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.
Time frame: Measured at post-intervention (8 weeks)
Food Security Status
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.
Time frame: Measured at baseline and post intervention (8 weeks)
Cognitive Functioning
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.
Time frame: Measured at baseline and post intervention (8 weeks)
Anxiety Symptoms
Generalized Anxiety Disorder-7 (GAD-7) total score (range 0-21). Higher scores indicate greater anxiety symptom severity.
Time frame: Measured at baseline and post intervention (8 weeks)
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9) total score (range 0-27). Higher scores indicate greater depressive symptom severity.
Time frame: Measured at baseline and post intervention (8 weeks)
Coping Behaviors
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.
Time frame: Measured at baseline and post intervention (8 weeks)
Diet Quality
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).
Time frame: Measured at baseline and post intervention (8 weeks)
Food resource management
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.
Time frame: Measured at baseline and post-intervention (8 weeks).
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Oklahoma State University