Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity
A Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity: a CBT-informed Pilot Study
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Rachel Liebe
- 電話番号：405-744-5043
- メール：rachel.liebe@okstate.edu
研究場所
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Oklahoma
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Stillwater、Oklahoma、アメリカ、74078
- 募集
- Oklahoma State University
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コンタクト：
- Rachel Liebe
- 電話番号：405-744-5043
- メール：rachel.liebe@okstate.edu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment feasibility
時間枠：Evaluated throughout recruitment and at completion of the recruitment period
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Percentage (%) of eligible individuals who enroll in the study among all individuals determined eligible through the screening survey.
Higher percentages indicate greater recruitment feasibility.
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Evaluated throughout recruitment and at completion of the recruitment period
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Intervention retention
時間枠：Measured from enrollment through completion of post-intervention data collection (8 weeks)
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Percentage (%) of enrolled participants who complete the post-intervention assessment.
Higher percentages indicate greater retention.
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Measured from enrollment through completion of post-intervention data collection (8 weeks)
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App Engagement
時間枠：Measured throughout the 8-week intervention period
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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.
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Measured throughout the 8-week intervention period
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Usability
時間枠：Measured at post-intervention (8 weeks)
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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
時間枠：Measured at post-intervention (8 weeks)
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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)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Food Security Status
時間枠：Measured at baseline and post intervention (8 weeks)
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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
時間枠：Measured at baseline and post intervention (8 weeks)
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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
時間枠：Measured at baseline and post intervention (8 weeks)
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Generalized Anxiety Disorder-7 (GAD-7) total score (range 0-21).
Higher scores indicate greater anxiety symptom severity.
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Measured at baseline and post intervention (8 weeks)
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Depressive Symptoms
時間枠：Measured at baseline and post intervention (8 weeks)
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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
時間枠：Measured at baseline and post intervention (8 weeks)
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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
時間枠：Measured at baseline and post intervention (8 weeks)
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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
時間枠：Measured at baseline and post-intervention (8 weeks).
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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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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