Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity

Official title

A Randomized Controlled Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity

Overview

The goal of this clinical trial is to learn if increased access to healthy foods, combined with behavioral weight loss (BWL) interventions, results in greater weight loss for adults with obesity and food insecurity. It will also learn about changes in health-quality of life and dietary quality. The main questions it aims to answer are: * Does BWL, combined with either home-delivered, medically-tailored (HOME) groceries or grocery vouchers (VOUCHER), result in greater weight loss than BWL alone? * Is the addition of HOME to BWL more effective at supporting adults with food insecurity and obesity to lose weight when compared to BWL and VOUCHER?

Detailed description

Participants will:

* Receive 21 sessions of BWL over 52 weeks delivered 1-on-1 with a counselor * Visit the research team for 4 in-person assessments to assess measures like height, weight, blood pressure, pulse, complete dietary assessments, questionnaires and interviews, and evaluate skin carotenoid levels (a non-invasive measure) * Be randomized (like picking numbers from a hat) to BWL-Alone; BWL+VOUCHER; or BWL+HOME. Participants in BWL+VOUCHER will receive grocery store gift cards every 2 weeks for the first 24 weeks of the study. Participants in BWL+HOME will receive groceries delivered to the home every 2 weeks for the first 24 weeks of the study.

Interventions

• Behavioral BWL
  Participants will receive a lifestyle modification program consisting of behavioral, physical activity, and dietary counseling delivered over 21, approximately 15 minute sessions delivered by trained interventionists. Sessions will be weekly during weeks 0-4, every other week during weeks 6-24, monthly during weeks 25-52. Treatment will be delivered remotely.
• Other VOUCHER
  During the initial 24 weeks, participants randomized to this group will receive the BWL program along with food vouchers distributed in the form of grocery store gift cards. Gift cards worth $60 will be emailed to participants every 2 weeks after their BWL session. From weeks 24-52, participants will continue to have monthly counseling sessions.
• Other HOME
  During the initial 24 weeks, participants assigned to this group will receive home-delivered, medically tailored groceries alongside BWL. The contents of each box will be approximately $60 ($30/week) and sent using Instacart. From weeks 24-52, participants will continue to have monthly counseling sessions.

Primary outcome measures

• Percent initial weight loss at week 24 (BWL+VOUCHER and BWL+HOME to BWL-Alone) [Time frame: Baseline to 24 weeks]

Secondary outcome measures (9)

• Percent initial weight loss at week 24 (BWL+VOUCHER versus BWL+HOME) [Time frame: Baseline to 24 weeks]
• Percent initial weight loss at week 52 (BWL+VOUCHER and BWL+HOME to BWL-Alone) [Time frame: Baseline to 52 weeks]
• Percent initial weight loss at week 52 (BWL+VOUCHER versus BWL+HOME) [Time frame: Baseline to 52 weeks]
• Change from baseline to weeks 24 and 52 in SF-36 Physical Component Score [Time frame: Baseline to week 24 and week 52]
• Change from baseline to weeks 24 and 52 in SF-36 Mental Component Score [Time frame: Baseline to week 24 and week 52]
• Change from baseline to weeks 24 and 52 in total Impact of Weight on Quality of Life scale [Time frame: Baseline to week 24 and week 52]
• Change from baseline to weeks 24 and 52 in total Healthy Eating Index score as measured using the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool [Time frame: Baseline to week 24 and week 52]
• Change from baseline to weeks 24 and 52 in skin carotenoid levels as measured by the Veggie Meter [Time frame: Baseline to week 24 and week 52]
• Incremental cost-effectiveness per unit decrease in weight (kg) [Time frame: Baseline to week 24 and week 52]

Eligibility criteria

Inclusion criteria

• BMI>30 kg/m2
• Screening positive for food insecurity using the well-validated, 10-item US Adult Food Security Survey Module.
• Age 18 years and older
• Completion of baseline assessments
• Ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest)
• Willing and able to provide pictures of food receipts to study team (or mail receipts to study team)
• Willing and able to provide written informed consent and participate in all study activities
• Female participants of child-bearing potential must agree in writing to use an approved method of contraception during the study

Exclusion criteria

• Significant psychiatric conditions (e.g., active substance abuse, schizophrenia) that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the program's behavioral recommendations
• Pregnant or planning pregnancy in the next year
• Planned move from the Baltimore area in the next year
• Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
• Previous or planned obesity treatment with surgery or a weight-loss device
• Weight loss of >5 kg in the previous 90 days
• Household member already participating in study due to potential contamination effects
• Lack of stable residence and ability to store and prepare food
• Lack of telephone
• Severe food allergies
• Following a specialized dietary regimen (e.g., gluten-free)

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

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Johns Hopkins University — Baltimore

Identifiers

NCT: NCT07396805 · IRB00528955 · R01NR021699

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗