Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity

17 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: mHealth app
Mobile phone-delivered content focused on building coping skills, managing stress, and supporting mental well-being among mothers experiencing food insecurity.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Recruitment feasibility
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Food Security Status
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Oklahoma State University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

20 juli 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 november 2026

Studieregistratiedata

Eerst ingediend

15 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juli 2026

Eerst geplaatst (Werkelijk)

22 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB-26-160

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren