Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity
A Randomized Controlled Trial of Food Is Medicine Approaches for Obesity Treatment in Adults With Food Insecurity
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study is for adults with obesity who do not always have enough food. It tests whether a program that helps people change habits to lose weight works better with home-delivered groceries chosen for their health needs or grocery vouchers than with the program alone. It also compares the two food options and looks at diet quality and how health affects daily life.
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?
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older with a BMI over 30. BMI is a measure of weight compared with height.
- A food access survey shows you do not always have enough food.
- Complete the study’s starting health checks and surveys.
- Can walk at least 2 blocks without stopping to rest.
- Willing and able to send photos of food receipts or mail the receipts to the study team.
- Willing and able to give written consent and take part in all study activities.
- Women who could become pregnant must agree in writing to use approved birth control during the study.
Who can't join
- A serious mental health condition, such as schizophrenia or active substance abuse, that could make the study unsafe, affect weight, or make it hard to follow the program.
- Pregnant or planning to become pregnant in the next year, or planning to move away from the Baltimore area in the next year.
- Recently started or changed the dose of a medicine that can cause a weight gain or loss of about 11 pounds (5 kg).
- Have had or plan to have weight-loss surgery or treatment with a weight-loss device.
- Lost more than 11 pounds (5 kg) in the past 90 days.
- Someone in your household is already in the study.
- Do not have a stable place to live where you can store and prepare food, or do not have a telephone.
- Have severe food allergies or follow a special diet, such as a gluten-free diet.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (1)
MD
- Johns Hopkins University · Baltimore, MD 21205More trials in Baltimore