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临床试验/NCT06428578
NCT06428578招募中不适用

Enhancing Food as Medicine Interventions for Food Insecure Postpartum Women in Central Texas

The University of Texas Health Science Center, Houston4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
4
主要终点
Change in quality of diet as assessed by number of times participants ate certain food items in the past month as reported in the questionnaire

研究概览

简要总结

The purpose of this study is to compare the short-term and long term impacts of Food is the Best Medicine (FBM)-Virtual on diet quality, food security status, breastfeeding rates, mental health status, rates of home cooking, and rationing coping strategies relative to FBM-In Person among food insecure, postpartum women and to compare implementation outcomes across the FBM-Virtual and FBM-In Person using process data collected from the participants, Community Health Worker (CHW)s, and partner organizations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • food insecure
  • to communicate in English or Spanish.

排除标准

  • not living within the food produce zip code delivery radius
  • having any dietary allergies.

结局指标

主要结局

Change in quality of diet as assessed by number of times participants ate certain food items in the past month as reported in the questionnaire

时间窗: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention

This data will be reported categorically for 14 different food items as follows: 1. fruit 2. green leafy or lettuce salad 3. fried potatoes 4. other kind of potatoes 5. refired/baked/ cooked beans 6. other vegetables that were not deep-fried 7. salsa made with tomato 8. pizza 9. tomato sauce 10. lean protein 11. plant-based protein 12. brown rice or other cooked whole grains 13. whole grain bread 14. regular soda/pop

Percentage of participants that face financial challenges as assessed by the Financial Self-Efficacy Scale

时间窗: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention

A single item from the Financial Self Efficacy scale will be used.

Change in level of household food insecurity experienced as assessed by the US Household Food Security questionnaire

时间窗: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention

This is an 6 item questionnaire . Raw score will be reported and score ranges from 0-6. Raw score of 0-1 shows high or marginal food security, raw score of 2- indicates low food security and raw score of 5-6 shows very low food insecurity.

Total duration of breastfeeding time as assessed by the post test questionnaires

时间窗: 3 months follow up

Number of participants that initiated breastfeeding as assessed by the pre test questionnaire

时间窗: Baseline

Change in financial stress as assessed by the financial stress questionnaire

时间窗: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention

Scores for three questions from the Financial Stress Scale will be used and each will be scored from 0(never) to 6(Always) for a score range of 0-18; 18 being highest level of financial stress.

Change in number of participants who showed signs of depression as assessed by the Edinburgh Postnatal Depression Scale (EPDS)

时间窗: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention

This is a 10 item questionnaire , range of score for each item is 0-3 for a total score range of 0-30, score above 12 is worse outcome

Change in number of cooked meals as assessed by the number of home cooked meals made from scratch during the past week

时间窗: Baseline, immediately after intervention (within 2 weeks of completion of intervention), three months after end of intervention

Participant will be asked how often he/she or anyone else in the family prepared breakfast from scratch during the past week, lunch from scratch during the past week or dinner from scratch during the past week. The responses from the 3 items will be summed to determine the number of home cooked meals during past week.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandra van den Berg

Professor

The University of Texas Health Science Center, Houston

研究点 (4)

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