Clinical trial NCT05635019: FoodRx for Obesity Treatment
Official title: Food Supplementation Interventions to Improve Weight Loss for Adults With Food Insecurity and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Food Insecurity
Keywords: obesity
food insecurity
weight loss
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-12-02
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: This study is a 3-group, parallel design, randomized controlled trial (RCT) in 105 adults with obesity and food insecurity that will compare BWL-Alone (including standard-of-care referral and connection with community food resources; n=35) to BWL plus food supplementation with either food vouchers (BWL+VOUCHER; n=35) or home-delivered, medically tailored groceries consistent with BWL recommendations (BWL+HOME; n=35). All groups will have BWL treatment provided for 24 weeks per clinical guidelines. Food vouchers and HOME will be provided for 24 weeks of treatment. Assessments will be conducted at baseline, and weeks 12 and 24.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Age \>18 years
4. BMI \>30 kg/m2 at screening visit
5. Screening positive for food insecurity using a score of \>3 on the 10-item US Adult Food Security Survey Module109
6. Completion of baseline assessments
7. Ability to engage in physical activity (i.e., can walk at least 2 blocks)
8. Willing and able to provide pictures of food receipts to study team (or mail actual receipts)
9. Ability to reliably receive packages at a consistent location in a timely manner
10. Telephone or internet service to communicate with study staff
11. For females of reproductive potential: agreement to use of highly effective contraception for during study participation

Exclusion Criteria:

1. Serious medical conditions (e.g., type 1 or type 2 diabetes, renal failure) 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
2. 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
3. Breastfeeding, pregnant or planning pregnancy in the next 6 months
4. Planned move from the Philadelphia area in the next 6 months
5. Weight loss of \>5 kg in the previous 90 days
6. Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg)
7. Previous or planned obesity treatment with surgery (excluding lap band if removed for \>1 year) or a weight-loss device
8. Use of prescription or over the counter medications for chronic weight management in the past 3 months
9. Household member already participating in study due to potential contamination effects
10. Lack of stable residence and ability to store and prepare food

Primary outcomes:
measure: Percent initial weight loss at 24 weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
timeFrame: Change from baseline to 24 weeks
Secondary outcomes:
measure: Percent initial weight loss at 24 weeks (BWL+HOME vs BWL+VOUCHER)
timeFrame: Change from baseline to 24 weeks
measure: General health-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
timeFrame: Change from baseline to 24 weeks
measure: Weight-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
timeFrame: Change from baseline to 24 weeks
measure: Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
timeFrame: Change from baseline to 24 weeks
measure: Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
timeFrame: Change from baseline to 24 weeks
measure: General health-related quality of life (BWL+VOUCHER vs BWL+HOME)
timeFrame: Change from baseline to 24 weeks
measure: Weight-related quality of life (BWL+VOUCHER vs BWL+HOME)
timeFrame: Change from baseline to 24 weeks
measure: Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER vs BWL+HOME)
timeFrame: Change from baseline to 24 weeks
measure: Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER vs BWL+HOME)
timeFrame: Change from baseline to 24 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: