Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity
17 juli 2026 uppdaterad av: RachelLiebe, Oklahoma State University
A Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity: a CBT-informed Pilot Study
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Rachel Liebe
- Telefonnummer: 405-744-5043
- E-post: rachel.liebe@okstate.edu
Studieorter
-
-
Oklahoma
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Stillwater, Oklahoma, Förenta staterna, 74078
- Rekrytering
- Oklahoma State University
-
Kontakt:
- Rachel Liebe
- Telefonnummer: 405-744-5043
- E-post: rachel.liebe@okstate.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: mHealth app
Mobile phone-delivered content focused on building coping skills, managing stress, and supporting mental well-being among mothers experiencing food insecurity.
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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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment feasibility
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Measured at post-intervention (8 weeks)
|
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Participant Acceptability
Tidsram: 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.
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Measured at post-intervention (8 weeks)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Food Security Status
Tidsram: 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.
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Measured at baseline and post intervention (8 weeks)
|
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Cognitive Functioning
Tidsram: 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.
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Measured at baseline and post intervention (8 weeks)
|
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Anxiety Symptoms
Tidsram: 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)
|
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Depressive Symptoms
Tidsram: 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.
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Measured at baseline and post intervention (8 weeks)
|
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Coping Behaviors
Tidsram: 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.
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Measured at baseline and post intervention (8 weeks)
|
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Diet Quality
Tidsram: 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).
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Measured at baseline and post intervention (8 weeks)
|
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Food resource management
Tidsram: 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.
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Measured at baseline and post-intervention (8 weeks).
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
20 juli 2026
Primärt slutförande (Beräknad)
1 november 2026
Avslutad studie (Beräknad)
1 november 2026
Studieregistreringsdatum
Först inskickad
15 juli 2026
Först inskickad som uppfyllde QC-kriterierna
17 juli 2026
Första postat (Faktisk)
22 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-26-160
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