[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07729436":3,"trial-entities:NCT07729436":107,"trial-summary:NCT07729436":110},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":45,"secondary_outcomes":50,"sex":63,"minimum_age":64,"maximum_age":65,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":74,"locations":77,"central_contacts":95,"overall_officials":97,"references":99,"see_also_links":106},"NCT07729436","STU00221030","Healthy Options At Pantries (HOAP) Study","Community-engaged Design and Implementation of a Behavioral Economics Food Choice Intervention in Food Pantries to Improve Cardiovascular Health","NOT_YET_RECRUITING","2029-03-31","2026-07","2026-07-27","2026-08-01","Northwestern University","OTHER",false,"This study will evaluate a digital nudge intervention, Healthy Options At Pantries (HOAP), in the online food pantries of three large charitable food organizations. The study will use a hybrid effectiveness-implementation design, meaning it will evaluate whether the intervention works and how it can best be rolled out in an online food pantry setting. Intervention effectiveness will be evaluated using an interrupted time series analysis to identify changes in how healthy foods ordered by shoppers are (primary outcome) by comparing food ordering data over time before and after HOAP is introduced. The study will also evaluate the possibility of collecting dietary and clinical outcomes in a small subgroup of online pantry shoppers over time comparing both in-person and at-home approaches.","This study will pilot and evaluate the Healthy Options At Pantries (HOAP) digital nudge intervention that was co-designed by pantry shoppers to encourage healthier food choices in online food pantries. We will evaluate the preliminary effectiveness of HOAP using an interrupted time series (ITS) to determine if HOAP implementation is associated with healthier online pantry orders by shoppers across three community organizations who operate online food pantries. The ITS analysis will compare 6 months of pre-intervention data to 6 months of during-intervention data to assess changes in food selection. The primary outcome is the healthfulness of items ordered by shoppers. In addition, we will qualitatively identify implementation factors that influence intervention success, including facilitators and barriers. We will also assess the feasibility and acceptability of longitudinally collecting diet quality, blood pressure, body composition, and weight data in 30 pantry shoppers comparing in-person and remote approaches to data collection over a 6- to 12-month period. Feasibility outcomes will include data completeness and acceptability of data collection procedures.",[19,20,21,22,23],"Food Choice","Implementation Science","Food Insecurity","Diet, Healthy","Behavioral Economics",[25,26,27,28,29,30],"Food insecurity","Digital nudges","Diet quality","Blood pressure","Weight","Body composition","INTERVENTIONAL","PREVENTION",[34],"NA",{"count":36,"type":37},300,"ESTIMATED",[39],{"type":40,"name":41,"description":42,"armGroupLabels":43},"BEHAVIORAL","Behavioral economics-based Healthy Options At Pantries (HOAP) digital nudge intervention","Intervention will include behavioral digital nudges over a 6-month period to promote healthier food selection among online food pantry shoppers.",[44],"HOAP Intervention Cohort",[46],{"measure":47,"description":48,"timeFrame":49},"Change in Healthfulness of Shopper Food Selection","The primary outcome is change in the healthfulness of shopper food selection over time, measured using the Charitable Food Network Index (CFNI). At each time point, food orders will be categorized into proportions of green, yellow, and orange items based on the Healthy Eating Research (HER) guidelines. These proportions will be combined into a composite CFNI score. CFNI scores range from 0 to 100, with higher scores indicating healthier overall food selections.","6 months pre-intervention and 6 months post-intervention",[51,54,57,60],{"measure":27,"description":52,"timeFrame":53},"Diet quality will be measured through up to two 24-hour dietary recalls using the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24).","3-6 months pre-intervention and 3-6 months post-intervention",{"measure":55,"description":56,"timeFrame":53},"Blood Pressure","Blood pressure will be measured using an automated blood pressure cuff. Blood pressure will be systolic and diastolic measures in mmHg. At each collection point, three blood pressure measurements will be obtained, and the average of the second and third measurements will be used for analysis.",{"measure":58,"description":59,"timeFrame":53},"Body Weight","Body weight will be measured in pounds using a medical-grade scale.",{"measure":61,"description":62,"timeFrame":53},"Body Composition","Body composition measures will include body fat percentage (range: 5-60%), visceral fat level (range: 1-30, lower values indicate lower visceral fat), and skeletal muscle percentage (range: 5-50%).","ALL","18 Years",null,true,{"inclusion":68,"exclusion":69,"raw_text":73},[],[70,71,72],"Weigh more than 300 pounds","Have a pacemaker, defibrillator, or other cardiac implant","Plan to move out of metro Chicago in the next 6 months","Eligibility Criteria:\n\n* Adults age 18 years or older\n* Speak English or Spanish\n* Access to a smartphone\n* Have ordered from the online food pantry at least half of the available times over the past 6 pantry eligible periods (for example, at least 3 times in the past 6 weeks for online food pantries that allow weekly ordering or at least 3 times in the past 6 months for online food pantries that allow monthly ordering), during the 6-month period prior to implementation of the HOAP program (i.e., months -6 to -1)\n* Plan to continue ordering from the online food pantry for the next 6 months\n\nExclusion Criteria:\n\n* Weigh more than 300 pounds\n* Have a pacemaker, defibrillator, or other cardiac implant\n* Plan to move out of metro Chicago in the next 6 months",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":13,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":92},"Chicago","Illinois","60611","United States",[84,89],{"name":85,"role":86,"phone":87,"email":88},"Emily Research Study Coordinator, MS","CONTACT","312-503-4917","emily.romero@northwestern.edu",{"name":90,"role":91},"Jenny Jia, MD, MSc","PRINCIPAL_INVESTIGATOR",{"lat":93,"lon":94},41.85003,-87.65005,[96],{"name":85,"role":86,"phone":87,"email":88},[98],{"name":90,"affiliation":13,"role":91},[100,103],{"type":101,"citation":102},"BACKGROUND","Schwartz M, Levi R, Lott M, Arm K, Seligman H. Healthy Eating Research Nutrition Guidelines for the Charitable Food System. Healthy Eating Research. Accessed Oct 7, 2021. https:\u002F\u002Fhealthyeatingresearch.org\u002Fwp-content\u002Fuploads\u002F2020\u002F02\u002Fher-food-bank_FINAL.pdf",{"pmid":104,"type":101,"citation":105},"36235551","Gombi-Vaca MF, Xu R, Schwartz M, Battista Hesse M, Martin K, Caspi CE. Validating a Nutrition Ranking System for Food Pantries Using the Healthy Eating Index-2015. Nutrients. 2022 Sep 21;14(19):3899. doi: 10.3390\u002Fnu14193899.",[],{"nct_id":4,"conditions":108,"biomarkers":109},[21],[],{"nct_id":4,"found":66,"summary":111,"prompt_version":121},{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This interventional study plans to enroll 300 participants. It will evaluate the HOAP digital nudge intervention using a hybrid effectiveness-implementation design.","completed","Healthy Options At Pantries (HOAP) Study for Online Food Pantry Shoppers","This study, called the Healthy Options At Pantries (HOAP) Study, is looking at a digital tool designed to help online food pantry shoppers choose healthier foods. The tool uses \"behavioral economics-based digital nudges,\" which are small prompts or suggestions, over six months. Researchers want to see if these nudges lead to healthier food choices. You can join if you are an adult aged 18 or older, speak English or Spanish, have a smartphone, and have used the online food pantry regularly. The main goal is to measure changes in how healthy the food you select is, comparing your choices before and after the HOAP tool is used. The study is currently unclear on its recruitment status.","The primary outcome of changes in food selection will be measured at 6 months pre-intervention and 6 months post-intervention. A subgroup may have data collected over a 6- to 12-month period.",116,"Participants will receive behavioral digital nudges over a 6-month period. A small group of 30 participants may also have diet quality, blood pressure, body composition, and weight data collected over 6 to 12 months.","Not stated in the trial record.",[],"v2"]