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Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity

A Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity: a CBT-informed Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07718646
Enrollment
30
Registered
2026-07-22
Start date
2026-07-20
Completion date
2026-11-01
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Insecurity

Keywords

Food Insecurity, Mental Health, Mobile Applications, Cognitive Behavioral Therapy, Stress, Psychological, Mothers, Depression, Anxiety

Brief summary

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.

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.

Interventions

BEHAVIORALMOMent

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.

Sponsors

Oklahoma State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Single arm feasibility trial with pre/post assessments

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Recruitment feasibilityEvaluated throughout recruitment and at completion of the recruitment periodPercentage (%) of eligible individuals who enroll in the study among all individuals determined eligible through the screening survey. Higher percentages indicate greater recruitment feasibility.
Intervention retentionMeasured 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.
App EngagementMeasured throughout the 8-week intervention periodIntervention 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.
UsabilityMeasured 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.
Participant AcceptabilityMeasured 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.

Secondary

MeasureTime frameDescription
Food Security StatusMeasured 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.
Cognitive FunctioningMeasured 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.
Anxiety SymptomsMeasured 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.
Depressive SymptomsMeasured 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.
Coping BehaviorsMeasured 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.
Diet QualityMeasured 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).
Food resource managementMeasured 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.

Countries

United States

Contacts

CONTACTRachel Liebe
rachel.liebe@okstate.edu405-744-5043

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026