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Not yet recruiting NCT07729436

Healthy Options At Pantries (HOAP) Study

No phase Interventional Food Choice Implementation Science Food Insecurity Diet, Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral economics-based Healthy Options At Pantries (HOAP) digital nudge intervention.
Who it may be relevant to
Registry conditions: Food Choice, Implementation Science, Food Insecurity, Diet, Healthy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Community-engaged Design and Implementation of a Behavioral Economics Food Choice Intervention in Food Pantries to Improve Cardiovascular Health

Overview

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.

Detailed description

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Healthfulness of Shopper Food Selection [Time frame: 6 months pre-intervention and 6 months post-intervention]
Secondary outcome measures (4)
  • Diet quality [Time frame: 3-6 months pre-intervention and 3-6 months post-intervention]
  • Blood Pressure [Time frame: 3-6 months pre-intervention and 3-6 months post-intervention]
  • Body Weight [Time frame: 3-6 months pre-intervention and 3-6 months post-intervention]
  • Body Composition [Time frame: 3-6 months pre-intervention and 3-6 months post-intervention]

Eligibility criteria

Eligibility Criteria:

  • Adults age 18 years or older
  • Speak English or Spanish
  • Access to a smartphone
  • 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)
  • Plan to continue ordering from the online food pantry for the next 6 months

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Northwestern University — Chicago

Publications

  • 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://healthyeatingresearch.org/wp-content/uploads/2020/02/her-food-bank_FINAL.pdf
  • 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/nu14193899. PMID 36235551

Identifiers

NCT: NCT07729436 · STU00221030 · K23HL173655

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗