Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
191 participants
INTERVENTIONAL
2016-07-06
2017-09-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Upgrade the Grains Study: Increasing Whole Grain Consumption in Low-income Children With Obesity
NCT02719730
Evaluating Covered California's Grocery Support Program
NCT07215897
Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
NCT06609473
Examining the Effects of Diet on Health in Prediabetes With an Online Program
NCT02188823
FoodSteps for Binge Eating & Food Insecurity
NCT06348251
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
The intervention consists of comprehensive, medically-appropriate food support (meals and groceries), individual nutritional counseling, and group-based nutritional education.
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.
Control
The control group will continue to receive their regular Project Open Hand services (standard of care) which includes 1-2 food services/day.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Project Open Hand
OTHER
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
References
Explore related publications, articles, or registry entries linked to this study.
Palar K, Napoles T, Hufstedler LL, Seligman H, Hecht FM, Madsen K, Ryle M, Pitchford S, Frongillo EA, Weiser SD. Comprehensive and Medically Appropriate Food Support Is Associated with Improved HIV and Diabetes Health. J Urban Health. 2017 Feb;94(1):87-99. doi: 10.1007/s11524-016-0129-7.
Whittle HJ, Palar K, Seligman HK, Napoles T, Frongillo EA, Weiser SD. How food insecurity contributes to poor HIV health outcomes: Qualitative evidence from the San Francisco Bay Area. Soc Sci Med. 2016 Dec;170:228-236. doi: 10.1016/j.socscimed.2016.09.040. Epub 2016 Oct 19.
Weiser SD, Hatcher AM, Hufstedler LL, Weke E, Dworkin SL, Bukusi EA, Burger RL, Kodish S, Grede N, Butler LM, Cohen CR. Changes in Health and Antiretroviral Adherence Among HIV-Infected Adults in Kenya: Qualitative Longitudinal Findings from a Livelihood Intervention. AIDS Behav. 2017 Feb;21(2):415-427. doi: 10.1007/s10461-016-1551-2.
Palar K, Laraia B, Tsai AC, Johnson MO, Weiser SD. Food insecurity is associated with HIV, sexually transmitted infections and drug use among men in the United States. AIDS. 2016 Jun 1;30(9):1457-65. doi: 10.1097/QAD.0000000000001095.
Whittle HJ, Palar K, Napoles T, Hufstedler LL, Ching I, Hecht FM, Frongillo EA, Weiser SD. Experiences with food insecurity and risky sex among low-income people living with HIV/AIDS in a resource-rich setting. J Int AIDS Soc. 2015 Nov 4;18(1):20293. doi: 10.7448/IAS.18.1.20293. eCollection 2015.
Whittle HJ, Palar K, Hufstedler LL, Seligman HK, Frongillo EA, Weiser SD. Food insecurity, chronic illness, and gentrification in the San Francisco Bay Area: An example of structural violence in United States public policy. Soc Sci Med. 2015 Oct;143:154-61. doi: 10.1016/j.socscimed.2015.08.027. Epub 2015 Aug 20.
Singer AW, Weiser SD, McCoy SI. Does Food Insecurity Undermine Adherence to Antiretroviral Therapy? A Systematic Review. AIDS Behav. 2015 Aug;19(8):1510-26. doi: 10.1007/s10461-014-0873-1.
Vogenthaler NS, Kushel MB, Hadley C, Frongillo EA Jr, Riley ED, Bangsberg DR, Weiser SD. Food insecurity and risky sexual behaviors among homeless and marginally housed HIV-infected individuals in San Francisco. AIDS Behav. 2013 Jun;17(5):1688-93. doi: 10.1007/s10461-012-0355-2.
Weiser SD, Young SL, Cohen CR, Kushel MB, Tsai AC, Tien PC, Hatcher AM, Frongillo EA, Bangsberg DR. Conceptual framework for understanding the bidirectional links between food insecurity and HIV/AIDS. Am J Clin Nutr. 2011 Dec;94(6):1729S-1739S. doi: 10.3945/ajcn.111.012070. Epub 2011 Nov 16.
Palar K, Sheira LA, Frongillo EA, O'Donnell AA, Napoles TM, Ryle M, Pitchford S, Madsen K, Phillips B, Riley ED, Weiser SD. Food Is Medicine for Human Immunodeficiency Virus: Improved Health and Hospitalizations in the Changing Health Through Food Support (CHEFS-HIV) Pragmatic Randomized Trial. J Infect Dis. 2025 Mar 17;231(3):573-582. doi: 10.1093/infdis/jiae195.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P0515916
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.