[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07718646":3,"trial-entities:NCT07718646":123,"trial-summary:NCT07718646":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":62,"sex":86,"minimum_age":87,"maximum_age":88,"healthy_volunteers":15,"eligibility_criteria":89,"std_ages":100,"locations":103,"central_contacts":118,"overall_officials":120,"references":121,"see_also_links":122},"NCT07718646","IRB-26-160","Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity","A Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity: a CBT-informed Pilot Study","RECRUITING","2026-11","2026-07","2026-07-22","2026-07-20","Oklahoma State University","OTHER",false,"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.\n\nThroughout 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.\n\nAfter 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.\n\nThis 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.",[19],"Food Insecurity",[19,21,22,23,24,25,26,27],"Mental Health","Mobile Applications","Cognitive Behavioral Therapy","Stress, Psychological","Mothers","Depression","Anxiety","INTERVENTIONAL","PREVENTION",[31],"NA",{"count":33,"type":34},30,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"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.",[41],"mHealth app",[43,47,51,55,59],{"measure":44,"description":45,"timeFrame":46},"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.","Evaluated throughout recruitment and at completion of the recruitment period",{"measure":48,"description":49,"timeFrame":50},"Intervention retention","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)",{"measure":52,"description":53,"timeFrame":54},"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.","Measured throughout the 8-week intervention period",{"measure":56,"description":57,"timeFrame":58},"Usability","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)",{"measure":60,"description":61,"timeFrame":58},"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.",[63,67,70,73,76,79,82],{"measure":64,"description":65,"timeFrame":66},"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.","Measured at baseline and post intervention (8 weeks)",{"measure":68,"description":69,"timeFrame":66},"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.",{"measure":71,"description":72,"timeFrame":66},"Anxiety Symptoms","Generalized Anxiety Disorder-7 (GAD-7) total score (range 0-21). Higher scores indicate greater anxiety symptom severity.",{"measure":74,"description":75,"timeFrame":66},"Depressive Symptoms","Patient Health Questionnaire-9 (PHQ-9) total score (range 0-27). Higher scores indicate greater depressive symptom severity.",{"measure":77,"description":78,"timeFrame":66},"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.",{"measure":80,"description":81,"timeFrame":66},"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).",{"measure":83,"description":84,"timeFrame":85},"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.","Measured at baseline and post-intervention (8 weeks).","ALL","18 Years",null,{"inclusion":90,"exclusion":96,"raw_text":99},[91,92,93,94,95],"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",[97,98],"Currently undergoing mental health counseling","No access to a smartphone (Apple or Android)","Inclusion Criteria:\n\n* Reside in Oklahoma\n* Identify as a woman or non-binary\n* At least 18 years old\n* Have a child under 18 years old living in your household\n* Experienced food insecurity in the past 30 days\n\nExclusion Criteria:\n\n* Currently undergoing mental health counseling\n* No access to a smartphone (Apple or Android)",[101,102],"ADULT","OLDER_ADULT",[104],{"facility":13,"status":8,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":115},"Stillwater","Oklahoma","74078","United States",[110],{"name":111,"role":112,"phone":113,"email":114},"Rachel Liebe","CONTACT","405-744-5043","rachel.liebe@okstate.edu",{"lat":116,"lon":117},36.11561,-97.05837,[119],{"name":111,"role":112,"phone":113,"email":114},[],[],[],{"nct_id":4,"conditions":124,"biomarkers":126},[27,26,19,21,125],"Psychological stress",[],{"nct_id":4,"found":128,"summary":129,"prompt_version":138},true,{"design":130,"status":131,"heading":6,"summary":132,"follow_up":133,"word_count":134,"commitments":135,"compensation":136,"drugs_mentioned":137},"This is a pilot study with 30 participants, meaning there is no comparison group. All participants will use the MOMent app.","completed","This study is testing a mobile app called MOMent, designed to help mothers experiencing food insecurity manage stress and build coping skills. If you live in Oklahoma, identify as a woman or non-binary, are at least 18 years old, have a child under 18, and have experienced food insecurity recently, you might be able to join. The study aims to see if the app is helpful and practical for future research by looking at how many people join, how many stay in the study, and how much they use the app. The current status of this study is unclear.","Participants will complete assessments after the 8-week intervention period.",99,"You would use the MOMent app for 8 weeks and complete surveys before and after using the app. Some participants may also be asked to do a follow-up interview.","Not stated in the trial record.",[38],"v2"]