Albin Jaclyn, Leonard Tammy, Wong Willis, Siler Milette, Haskins Carolyn, Turcios Jessica, Pruitt Sandi L, Bowen Michael, Pezzia Carla, Ford Alisha, Schinzer Bianca, Hollis-Hansen Kelseanna
Internal Medicine, UT Southwestern Medical Center, Dallas, Texas, USA.
O'Donnell School of Public Health, UT Southwestern Medical Center, Dallas, Texas, USA.
BMJ Open. 2025 Jan 2;15(1):e096122. doi: 10.1136/bmjopen-2024-096122.
Linking patients living with chronic, diet-related diseases and food insecurity to charitable food assistance, medically tailored groceries (MTGs) and food resource coaching may empower patients to better manage their health in a way that is economically sustainable. This protocol paper describes the implementation of a study evaluating MTGs and food resource coaching in a food pantry setting.
A randomised controlled trial whereby patients of a safety-net health centre will be screened for The Emergency Food Assistance Program (TEFAP) and study eligibility. Eligible patients will be randomised to receive 4 months of usual pantry services (control), MTGs (intervention 1) or MTGs and food resource coaching (intervention 2) from a colocated food pantry. Measures collected monthly include adherence, fidelity and food selections from the pantry. Measures collected at baseline and follow-up include food and nutrition security, diet quality, household resiliency, loneliness and overall well-being. Qualitative interviews (n=60) will be conducted preintervention and postintervention. Analyses will include multiple regression models to analyse changes from baseline to follow-up as well as changes between groups over time. Deductive thematic analysis of qualitative data will be conducted.
This study was approved by the UT Southwestern Medical Center Institutional Review Board (STU-2023-1166) and the Parkland Health Office of Research Administration. This is protocol version two, modification approved on 3 June 2024. Findings will be disseminated through academic conferences, journals and to the public.
NCT06242808.
将患有慢性饮食相关疾病且面临粮食不安全问题的患者与慈善食品援助、医疗定制食品杂货（MTG）及食品资源指导相联系，可能会使患者有能力以经济可持续的方式更好地管理自身健康。本方案文件描述了一项在食品储藏室环境中评估MTG和食品资源指导的研究的实施情况。
一项随机对照试验，将对安全网健康中心的患者进行筛选，以确定其是否符合紧急食品援助计划（TEFAP）及研究资格。符合条件的患者将被随机分配，从同一地点的食品储藏室接受4个月的常规储藏室服务（对照组）、MTG（干预1）或MTG及食品资源指导（干预2）。每月收集的指标包括依从性、保真度以及从储藏室选取的食品。在基线和随访时收集的指标包括食品和营养安全、饮食质量、家庭恢复力、孤独感及总体幸福感。将在干预前和干预后进行定性访谈（n = 60）。分析将包括多元回归模型，以分析从基线到随访的变化以及不同组随时间的变化。将对定性数据进行演绎主题分析。
本研究已获得德克萨斯大学西南医学中心机构审查委员会（STU - 2023 - 1166）和帕克兰健康研究管理办公室的批准。这是方案版本二，于2024年6月3日批准修改。研究结果将通过学术会议、期刊及向公众进行传播。
NCT06242808。
