A Mobile Health Coping Intervention for Mothers Experiencing Food Insecurity: a CBT-informed Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Currently undergoing mental health counseling
- •No access to a smartphone (Apple or Android)
结局指标
主要结局
Recruitment feasibility
时间窗: 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.
Intervention retention
时间窗: 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.
App Engagement
时间窗: 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.
Usability
时间窗: 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.
Participant Acceptability
时间窗: 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.
次要结局
- Food Security Status(Measured at baseline and post intervention (8 weeks))
- Cognitive Functioning(Measured at baseline and post intervention (8 weeks))
- Anxiety Symptoms(Measured at baseline and post intervention (8 weeks))
- Depressive Symptoms(Measured at baseline and post intervention (8 weeks))
- Coping Behaviors(Measured at baseline and post intervention (8 weeks))
- Diet Quality(Measured at baseline and post intervention (8 weeks))
- Food resource management(Measured at baseline and post-intervention (8 weeks).)
研究者
RachelLiebe
Assistant Professor
Oklahoma State University