Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07396805

Recruiting nowNot applicableInterventional

What this study is about

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?

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity & Overweight

Full registry 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)

Treatments and study arms

BWL

Behavioral

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.

VOUCHER

Other

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.

HOME

Other

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 outcomes

Percent initial weight loss at week 24 (BWL+VOUCHER and BWL+HOME to BWL-Alone)Baseline to 24 weeks

Comparison of BWL+VOUCHER and BWL+HOME to BWL-Alone for weight loss (percent of baseline weight) at 24 weeks

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Johns Hopkins University🇺🇸 Baltimore, Maryland, United States