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R01NR021699

Project Grant

Overview

Grant Description
A RANDOMIZED CONTROLLED TRIAL OF FOOD IS MEDICINE APPROACHES FOR OBESITY TREATMENT IN ADULTS WITH FOOD INSECURITY - FOOD INSECURITY IS COMMON AMONG ADULTS WITH OBESITY AND IS ASSOCIATED WITH LESS FAVORABLE OUTCOMES IN BEHAVIORAL WEIGHT LOSS (BWL) INTERVENTIONS. THERE IS A LACK OF EVIDENCE ON TREATMENT STRATEGIES THAT ARE EFFECTIVE IN ADDRESSING BOTH FOOD INSECURITY AND OBESITY. THE PRIMARY OBJECTIVE OF THIS PROPOSAL IS TO IMPROVE OBESITY TREATMENT AMONG ADULTS WITH FOOD INSECURITY BY ENHANCING PATIENTS' CAPACITY TO AFFORD AND OBTAIN NUTRITIOUS FOODS DURING BWL. TO ACHIEVE THIS OBJECTIVE, WE WILL CONDUCT A RANDOMIZED CONTROLLED TRIAL WITH A 3-GROUP, PARALLEL DESIGN THAT ENROLLS 300 ADULTS WITH OBESITY AND FOOD INSECURITY. PARTICIPANTS WILL BE ASSIGNED TO ONE OF THREE GROUPS: BWL-ALONE (N=100), BWL WITH FOOD SUPPLEMENTATION VIA EITHER FOOD VOUCHERS (BWL+VOUCHER; N=100), OR HOME-DELIVERED, MEDICALLY TAILORED GROCERIES CONSISTENT WITH BWL RECOMMENDATIONS (BWL+HOME; N=100). FOOD VOUCHERS AND HOME PROVISIONS WILL BE PROVIDED FOR THE INITIAL 24 WEEKS OF TREATMENT. ALL GROUPS WILL RECEIVE BWL TREATMENT FOR 52 WEEKS IN ACCORDANCE WITH TREATMENT GUIDELINES. ASSESSMENTS WILL OCCUR AT BASELINE AND AT WEEKS 12, 24 (CONCLUSION OF FOOD SUPPLEMENTATION), AND 52 (COMPLETION OF BWL TREATMENT). OUR PRIMARY AIMS ARE TO ASSESS WHETHER BWL+VOUCHER AND BWL+HOME YIELD GREATER WEIGHT LOSS (PERCENTAGE OF INITIAL WEIGHT) AT 24 WEEKS COMPARED TO BWL-ALONE. SECONDARY OBJECTIVES ARE TO EXAMINE DIFFERENCES IN PERCENT WEIGHT LOSS BETWEEN BWL+HOME VS BWL+VOUCHER AT WEEK 24, AND TO ASSESS CHANGES AMONG GROUPS FROM BASELINE TO 52 WEEKS. ADDITIONAL SECONDARY GOALS ARE TO INVESTIGATE CHANGES IN HEALTH-RELATED QUALITY OF LIFE AND SELF-REPORTED AND OBJECTIVE MEASURES OF DIETARY QUALITY ACROSS TREATMENT GROUPS. OUR EXPLORATORY AIM IS TO CONDUCT AN ECONOMIC ANALYSIS TO EVALUATE THE COST-EFFECTIVENESS OF EACH INTERVENTION. THE ANTICIPATED OUTCOME OF THIS STUDY IS TO PROVIDE EVIDENCE OF FEASIBLE FOOD SUPPORT INTERVENTIONS APPLICABLE WITHIN HEALTHCARE SYSTEMS TO IMPROVE NUTRITION IN PEOPLE WITH OBESITY.
Funding Goals
NURSES UNDERSTAND THAT IMPROVING HEALTH AND WELL-BEING MEANS ADDRESSING PEOPLE'S NEEDS IN MULTIPLE SETTINGS, CONTEXTS, AND OVER THE WHOLE LIFE COURSE. SCIENCE SUPPORTED BY THE NATIONAL INSTITUTE OF NURSING RESEARCH (NINR) USES THIS HOLISTIC PERSPECTIVE TO IMPROVE INDIVIDUAL AND POPULATION HEALTH AND ADVANCE HEALTH EQUITY. NINR-SUPPORTED RESEARCH PROMOTES HEALTH AND WELL-BEING BY ADDRESSING NEEDS AT MULTIPLE LEVELS INDIVIDUAL, FAMILY, COMMUNITY, AND SOCIETAL LEVELS AND DEVELOPING TREATMENT AND PREVENTION STRATEGIES THAT ARE RESPONSIVE TO THE REALITY OF PEOPLE'S LIVES. NURSES KNOW PEOPLE, AND PEOPLE TRUST NURSES. PATIENT AND FAMILIES INTERACT WITH NURSES MORE THAN ANY OTHER CLINICIANS. NURSING SCIENCE USES THIS SPECIAL RELATIONSHIP TO BETTER UNDERSTAND PATIENTS, FAMILIES, AND COMMUNITIES AND THE MANY FACTORS THAT INFLUENCE THEIR HEALTH. NURSING SCIENCE SUPPORTED BY NINR USES THIS KNOWLEDGE TO DEVELOP STRATEGIES FOR IMPROVING HEALTH AND WELLNESS ACROSS POPULATIONS, HEALTH CARE SETTINGS, AND THE LIFESPAN, WITH AN EMPHASIS ON ACHIEVING HEALTH EQUITY. NINR-SUPPORTED SCIENTISTS HAVE DEVELOPED INTERVENTIONS FOR: SUPPORTING PARENTS OF PREMATURE INFANTS, PROMOTING HIV PREVENTION IN UNDERSERVED POPULATIONS, IMPROVING TRANSITIONAL CARE LEADING TO BETTER OUTCOMES AND COST-SAVINGS, AND HELPING INNER-CITY CHILDREN MANAGE ASTHMA. NURSING SCIENCE TRANSCENDS THE BOUNDARIES OF DISEASE AND RESEARCH DISCIPLINES TO BETTER UNDERSTAND THE EXPERIENCES OF INDIVIDUALS AND FAMILIES LIVING WITH ILLNESS AND TO DEVELOP PERSONALIZED APPROACHES THAT MAXIMIZE HEALTH AND WELL-BEING FOR INDIVIDUALS AT ALL STAGES OF LIFE, ACROSS DIVERSE POPULATIONS AND SETTINGS. NINR-SUPPORTED SCIENCE USES NURSING SCIENCE'S UNIQUE, PATIENT AND COMMUNITY-FOCUSED PERSPECTIVE AND WIDE REACH ACROSS CLINICAL AND COMMUNITY SETTINGS TO ADVANCE OUR UNDERSTANDING OF THE SOCIAL DETERMINANTS OF HEALTH: THOSE FACTORS THAT ARE AT THE ROOT OF THE INEQUITIES THAT WE SEE, SUCH AS FOOD INSECURITY AND ACCESS TO HEALTHCARE. NINR RESEARCH EFFORTS IN WELLNESS INVESTIGATE THE KEY BIOLOGICAL, BEHAVIORAL, AND SOCIAL FACTORS THAT PROMOTE LONG-TERM HEALTH AND HEALTHY BEHAVIORS AND PREVENT THE DEVELOPMENT OF ILLNESS ACROSS HEALTH CONDITIONS, SETTINGS, AND THE LIFESPAN. RESEARCH IN WELLNESS IS ALSO FOCUSED ON DEVELOPING AND TESTING CULTURALLY APPROPRIATE INTERVENTIONS TO PROMOTE HEALTH AND PREVENT ILLNESS IN MINORITY AND UNDERSERVED GROUPS. NINR ALSO SUPPORTS SCIENCE TO ASSIST INDIVIDUALS, FAMILIES, AND HEALTH CARE PROFESSIONALS IN MANAGING ADVANCED, SERIOUS ILLNESS, AND PLANNING FOR END-OF-LIFE DECISIONS. IN ADDITION, NINR PROMOTES TECHNOLOGICAL ADVANCEMENTS THAT ADDRESS A RANGE OF HEALTH CARE CHALLENGES AND FACILITATE THE DELIVERY OF REAL-TIME PERSONALIZED INFORMATION TO INDIVIDUALS AND FAMILIES, HEALTH CARE PROVIDERS, AND COMMUNITIES. FINALLY, NINR HAS A LONGSTANDING AND CONTINUING COMMITMENT TO DEVELOPING THE NEXT GENERATION OF NURSE SCIENTISTS: THOSE INDIVIDUALS AND TEAM MEMBERS WHO WILL CARRY THE FIELD OF NURSING SCIENCE INTO THE FUTURE. IN ORDER TO PREPARE AN INNOVATIVE, DIVERSE, AND TALENTED NEXT GENERATION OF NURSE SCIENTISTS, NINR SUPPORTS A VARIETY OF TRAINING OPPORTUNITIES FOR SCIENTISTS AND TRAINEES AT ALL CAREER LEVELS, PARTICULARLY THOSE AT AN EARLY CAREER STAGE WHO ARE SO CRITICAL TO SUSTAINING THE FUTURE OF INNOVATIVE RESEARCH AND HIGH QUALITY HEALTH CARE.
Grant Program (CFDA)
Place of Performance
Maryland United States
Geographic Scope
State-Wide
The Johns Hopkins University was awarded Food Support Interventions Obesity Food Insecurity: A Randomized Trial Project Grant R01NR021699 worth $3,690,570 from the National Institute of Nursing Research in September 2025 with work to be completed primarily in Maryland United States. The grant has a duration of 4 years and was awarded through assistance program 93.361 Nursing Research. The Project Grant was awarded through grant opportunity NINR Areas of Emphasis for Research to Optimize Health and Advance Health for All (R01 Clinical Trial Optional).

Status
(Ongoing)

Last Modified 9/24/25

Period of Performance
9/11/25
Start Date
8/31/29
End Date
1.0% Complete

Funding Split
$3.7M
Federal Obligation
$0.0
Non-Federal Obligation
$3.7M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01NR021699

Additional Detail

Award ID FAIN
R01NR021699
SAI Number
R01NR021699-2356752723
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75N200 NIH National Institute of Nursing Research
Funding Office
75N200 NIH National Institute of Nursing Research
Awardee UEI
FTMTDMBR29C7
Awardee CAGE
5L406
Performance District
MD-90
Senators
Benjamin Cardin
Chris Van Hollen
Modified: 9/24/25