Changing Health Through Food Support (CHEFS) Program (CHEFS)

March 7, 2022 updated by: University of California, San Francisco

Changing Health Through Food Support (CHEFS): Pilot RCT to Identify Potential Health Impacts of Providing Comprehensive, Medically-appropriate Food Support to Low-income Urban Adults Living With HIV (PLHIV)

UCSF and Project Open Hand (POH), a community based organization in San Francisco which provides meals and groceries to chronically ill clients in the Bay Area, have partnered to conduct an initial randomized controlled trial (RCT) of the Changing Health through Food Support (CHEFS) pilot intervention implemented by POH. The intervention consists of providing comprehensive, medically-appropriate food support, individual nutritional counseling, and group-based nutritional education over 6 months to low-income clients who have been diagnosed with HIV in order to improve their viral load and health-related quality of life (primary outcomes) as well as depression, ART adherence, food security and diet quality (secondary outcomes). We will randomize 200 participants to the intervention (n=100) or control (n=100). Participants will be followed for 6 months. The investigators will assess outcomes at baseline and 6-month follow-up using a quantitative survey and blood draws. In addition, the investigators will conduct a qualitative study at follow-up in a subset of participants to understand perceived impacts, barriers and facilitators.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV positive
  • Income at or below 200% FPL (~$2400/month)
  • 30-50% minimum POH regular program adherence level (i.e. regular service access rate)
  • Are willing and able to eat food from POH based on one of POH's regularly available diet choices (including regular, non-dairy, vegetarian, vegetarian non-dairy, diabetic, and bland), excluding the renal diet.
  • Have access to a refrigerator or freezer with sufficient space to store perishable food provided by POH, and have access to an appliance to reheat food.

Exclusion Criteria:

  • Do not speak Spanish or English
  • Do not have adequate cognitive or hearing capacity to complete interviews
  • Have a history of violent behavior at POH (such as verbal or physical abuse to other clients and/or staff)
  • Have renal disease requiring a special renal diet
  • Have severe food allergies
  • Currently pregnant or <6 months post-partum
  • Unable to complete an interview due to a health condition
  • Unable or unwilling to eat food from POH (based on one of POH's regularly available diet choices)
  • Among people who share a household (such as partners, family members, or roommates), only one may be involved in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention consists of comprehensive, medically-appropriate food support (meals and groceries), individual nutritional counseling, and group-based nutritional education.
Other: Medically-appropriate meals and groceries
Full nutrition Intervention Components: (1) 7 pre-packaged frozen meals; (2) Groceries or another 7-pack of meals; (3) Nutritional supplement bag to round out the nutrition in terms of nutrients, or dietary reference intakes (DRIs), and number of servings from fruits/vegetables, whole grains, legumes, nuts/seeds and dairy. The nutritional supplemental bag will also contain bulk ingredients to aid in cooking e.g., cooking oil, spices, and herbs as well as bulk items e.g., jar of peanut butter, quart of milk; (4) Individual nutritional counseling (x2 sessions); and (5) Group nutrition education classes (X3 classes) by POH registered dietitian (RD) team.
No Intervention: Control
The control group will continue to receive their regular Project Open Hand services (standard of care) which includes 1-2 food services/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline HIV viral load suppression at 6 months in the intervention compared to the control group
Time Frame: Assessed at baseline and 6 months
Nondetectable HIV viral load
Assessed at baseline and 6 months
Change from baseline health-related quality of life at 6 months in the intervention compared to the control group
Time Frame: Assessed at baseline and 6 months
Short-form SF-36, a validated tool to assess health-related quality of life
Assessed at baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline depression at 6 months in the intervention compared to the control group
Time Frame: Assessed at baseline and 6 months
Patient Health Questionnaire (PHQ-9), a validated tool to diagnose the severity of depression
Assessed at baseline and 6 months
Change from baseline ART adherence at 6 months in the intervention compared to the control group
Time Frame: Assessed at baseline and 6 months
Visual Analogue Scale (VAS), a measure of adherence validated among people living with HIV
Assessed at baseline and 6 months
Change from baseline diet quality at 6 months in the intervention compared to the control group
Time Frame: Assessed at baseline and 6 months
18-items adapted from National Cancer Institute Multifactor Screener, a validated tool to assess approximate intakes of fruits, vegetables, fats, proteins, dairy, grains, and sugars
Assessed at baseline and 6 months
Change from baseline food security at 6 months in the intervention compared to the control group
Time Frame: Assessed at baseline and 6 months
U.S. Household Food Security Survey (HFSS), a validated tool to assess food insecurity
Assessed at baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Project Open Hand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2016

Primary Completion (Actual)

September 28, 2017

Study Completion (Actual)

September 28, 2017

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 19, 2017

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0515916

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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