Food Rx: Food Supplementation Interventions to Improve Weight Loss for Adults With Food Insecurity and Obesity
Not Recruiting
18-100 years
All
Phase
2
105 participants needed
1 Location
Brief description of study
The purpose of this intervention research
project is to conduct a randomized controlled trial in adults with
obesity and food insecurity to assess whether behavioral weight loss treatment and providing
food or resources for food can improve weight loss, diet quality, and perceived
physical and mental health in individuals with obesity and food insecurity. Food
insecurity is defined as a lack of regular access to enough safe and nutritious
food for normal growth and development and an active and healthy life.
Detailed description of study
All participants will receive behavioral weight loss counseling. The behavioral weight loss program consists of 14 individual lifestyle counseling sessions. Each session will be approximately 15-20 minutes. Visits will be scheduled weekly for the first 4 weeks and every other week from weeks 6-24. With the exception of the three assessment visits (screening, week 12, and week 24) all counseling sessions can be conducted virtually.
Participants will be randomized (like the flip of a coin) to one of three groups. Groups include:
1. Behavioral weight loss counseling as described above;
2. Behavioral weight loss counseling + grocery store gift cards worth $40 every 2 weeks
3. Behavioral weight loss counseling + groceries mailed to your house. Every 2 weeks you will get to choose 1 out of 4 boxes that have approximately $40 worth of food
In addition, we will ask you to complete 3 assessment visits; one at the beginning, one in the middle (week 12), and one at the end of the study (week 24). These assessment visits must be conducted in person at the Center for Weight and Eating Disorders at the University of Pennsylvania's campus.
Assessments include:
o Questionnaires that ask about your physical and mental health, eating behaviors, mood, physical activity, and ability to afford and access food. These take about 30 minutes to complete.
o Measures of your weight, height, waist circumference, blood pressure
o Measure of your health using non-invasive scans of your finger
o 24-hour diet recall conducted in-person
o 24-hour diet recall conducted by phone
Patients are eligible to receive $120 compensation for participation in the study.
Additional InformationDuring this study, participants will be asked not to seek any other lifestyle, pharmacologic, or surgical treatments for obesity
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Obesity
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Age ≥ 18 years
- BMI ≥ 30 kg/m2
- Screening positive for food insecurity using a score of ≥ 3 on the 10-item US Adult Food Security Survey Module
- Completion of baseline assessments
- Ability to engage in physical activity (i.e., can walk at least 2 blocks)
- Willing and able to provide pictures of food receipts to the study team (or mail actual receipts)
- Ability to reliably receive packages at a consistent location in a timely manner
- Telephone or internet service to communicate with study staff
- For females of reproductive potential: agreement to use of highly effective contraception for the duration of study participation
Exclusion criteria
- Serious medical conditions (e.g. type 1 or type 2 diabetes, renal failure) that may pose a risk to the participant during the intervention, cause a change in weight, or limit the ability to adhere to the program's behavioral recommendations
- Significant psychiatric conditions (e.g, active substance abuse, schizophrenia) that may pose a risk to the participant during the intervention, cause a change in weight, or limit the ability to adhere to the program's behavioral recommendations
- Breastfeeding, pregnant or planning pregnancy in the next 6 months (because weight loss is typically discouraged during pregnancy and there is minimal literature on the safety of dietary restrictions necessary for intentional weight loss during gestation; and guidelines such as those from IOM, recommend weight gain (though weight gain targets are lower) for pregnant people with obesity)
- Planned move from the Philadelphia area in the next 6 months
- Weight loss of >5 kg in the previous 90 days
- 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 (excluding lap band if removed for >1 year) or a weight-loss device
- Use of prescription or over-the-counter medications for chronic weight management in the past 3 months
- Household member already participating in study due to potential contamination effects
- Lack of stable residence and ability to store and prepare food
Updated on
16 Nov 2024.
Study ID: 852467
