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A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity (SuperShelf)

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ClinicalTrials.gov Identifier: NCT03421106
Recruitment Status : Terminated (Data collection was halted prematurely due to COVID-19.)
First Posted : February 5, 2018
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Caitlin Caspi, University of Connecticut

Tracking Information
First Submitted Date  ICMJE January 29, 2018
First Posted Date  ICMJE February 5, 2018
Last Update Posted Date October 8, 2021
Actual Study Start Date  ICMJE February 5, 2018
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
Overall diet quality of clients [ Time Frame: Baseline, 1 year ]
Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the highest possible score.
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
Overall diet quality of clients [ Time Frame: Baseline, 1 year ]
Assessed by Healthy Eating Index-2010 scores (scale 0-100), with 100 representing the highest possible score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • Nutritional quality of food selected by clients at the food pantry [ Time Frame: Baseline, 1 year ]
    Assessed by Healthy Eating Index-2015 scores (scale 0-100), with 100 representing the highest possible score.
  • Cardiovascular health [ Time Frame: Baseline, 1 year ]
    American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -7), with 7 representing the highest possible score
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2018)
  • Nutritional quality of food selected by clients at the food pantry [ Time Frame: Baseline, 1 year ]
    Assessed by Healthy Eating Index-2010 scores (scale 0-100), with 100 representing the highest possible score.
  • Cardiovascular health [ Time Frame: Baseline, 1 year ]
    American Heart Association's Life's Simple 7 (LS7) scores (scale 0 -14), with 14 representing the highest possible score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity
Official Title  ICMJE A Multilevel Intervention in the Hunger Relief Network to Improve Diet Among Adults Experiencing Food Insecurity
Brief Summary The investigator proposes an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries. We will enroll 272 clients at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome).
Detailed Description Evaluate the health impact of an intervention targeting the hunger relief network and the clients with food insecurity it serves. The long-term goal of this work is to reduce nutrition-related health disparities by intervening on a system that serves individuals at high risk for chronic disease. In 2014, an estimated 14% of U.S. households experienced food insecurity (i.e., they lacked access to enough food for an active, healthy life for all household members). Large numbers of low-income, racial/ethnic minority, and immigrant families who experience food insecurity rely on a hunger relief network that includes food banks and food pantries. Pantry clients have demonstrated poor nutritional outcomes, high chronic disease rates, and dissatisfaction with the quality and cultural-appropriateness of food offered. Unlike other food assistance programs, there are currently no standards on the nutritional quality of pantry offerings, but recent work by our study team demonstrated the need to improve the healthfulness of hunger relief network inventory. We proposed an evaluation of a randomized, sustainable intervention in 8 intervention and 8 control pantries. We will enroll 272 clients at baseline and follow them for 1 year to assess changes in overall diet quality (the primary outcome). Working with our food bank partners, the intervention at the pantry level targets the supply of nutritious foods. At the client level, the intervention targets healthy food demand. Measured outcomes include overall diet quality (the primary outcome), as assessed by the Healthy Eating Index-2015 (HEI), the nutritional quality of foods selected at the food shelf visit, and cardiovascular disease health (assessed by the American Heart Association's Life's Simple 7 scores). The study will also evaluate the impact of a multilevel intervention on the nutritional quality of pantry offerings. The study also aims to improve implementation of practices that promote a nutrition-focused hunger relief network, as assessed by survey and key informant interviews. As an exploratory aim, the study will evaluate the cultural appropriateness of pantry foods and services, given the burden of poor food access on minority, immigrant, and refugee families.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Food Selection
Intervention  ICMJE
  • Behavioral: Intervention Food Pantries
    Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors.
  • Other: Control Food Pantries
    Normal food pantry use
Study Arms  ICMJE
  • Experimental: Intervention Food Pantries
    Food pantries will transform to offer healthier and more appealing food ; the effect on clients will be measured.
    Intervention: Behavioral: Intervention Food Pantries
  • Active Comparator: Control Food Pantries
    Food pantries will make no changes during the evaluation period; the effect on clients will be measured.
    Intervention: Other: Control Food Pantries
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 12, 2021)
504
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2018)
544
Actual Study Completion Date  ICMJE November 16, 2020
Actual Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-≥18 years old

  • Mentally capable of consent and participation
  • Speak English, Spanish, or Somali
  • Have access to a phone

Exclusion Criteria:

  • Not capable of consent or participation
  • Speak only languages other than English, Spanish or Somali
  • Not a food pantry user
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03421106
Other Study ID Numbers  ICMJE H20-0076
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Caitlin Caspi, University of Connecticut
Original Responsible Party University of Minnesota
Current Study Sponsor  ICMJE University of Connecticut
Original Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Caitlin E Caspi, ScD University of Connecticut
PRS Account University of Connecticut
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP