FoodRx for Obesity Treatment

Not Applicable

Active, not recruiting

• Conditions: Food Insecurity; Obesity
• Interventions: Behavioral: BWL+VOUCHER; Behavioral: BWL+HOME; Behavioral: Behavioral weight loss counseling (BWL)

• Registration Number: NCT05635019
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-11-22
• Study Start: 2022-12-01
• Study First Posted: 2022-12-02
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BWL+VOUCHER	BWL+VOUCHER	BWL counseling and gift cards to grocery stores
BWL+HOME	BWL+HOME	BWL counseling and home-delivered boxes of groceries
BWL+VOUCHER	Behavioral weight loss counseling (BWL)	BWL counseling and gift cards to grocery stores
Behavioral weight loss counseling (BWL) alone	Behavioral weight loss counseling (BWL)	BWL counseling alone
BWL+HOME	Behavioral weight loss counseling (BWL)	BWL counseling and home-delivered boxes of groceries

Primary Outcome Measures

Name	Time	Method
Percent initial weight loss at 24 weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	Change from baseline to 24 weeks	Comparison of BWL+VOUCHER and BWL+HOME vs BWL-Alone in weight loss (percent of initial weight) at 24 weeks.

Secondary Outcome Measures

Name	Time	Method
General health-related quality of life (BWL+VOUCHER vs BWL+HOME)	Change from baseline to 24 weeks	Change from baseline to week 24 in general health-related quality of life as assessed with the Short Form-36. Scores range from 0 (worse) to 100 (best).
General health-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	Change from baseline to 24 weeks	Change from baseline to week 24 in general health-related quality of life as assessed with the Short Form-36. Scores range from 0 (worse) to 100 (best).
Weight-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	Change from baseline to 24 weeks	Change from baseline to week 24 in weight-related quality of life as assessed with the Impact of Weight on Quality of Life-Lite. Scores range from 0 (worse) to 100 (best).
Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	Change from baseline to 24 weeks	Change from baseline to week 24 in Healthy Eating Index scores as measured with the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. Scores range from 0 (worse) to 100 (best).
Weight-related quality of life (BWL+VOUCHER vs BWL+HOME)	Change from baseline to 24 weeks	Change from baseline to week 24 in weight-related quality of life as assessed with the Impact of Weight on Quality of Life-Lite. Scores range from 0 (worse) to 100 (best).
Percent initial weight loss at 24 weeks (BWL+HOME vs BWL+VOUCHER)	Change from baseline to 24 weeks	Comparison of BWL+HOME vs BWL+VOUCHER in weight loss (percent of initial weight) at 24 weeks.
Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	Change from baseline to 24 weeks	Change from baseline to week 24 in skin carotenoid levels
Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER vs BWL+HOME)	Change from baseline to 24 weeks	Change from baseline to week 24 in skin carotenoid levels
Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER vs BWL+HOME)	Change from baseline to 24 weeks	Change from baseline to week 24 in Healthy Eating Index scores as measured with the ASA24. Scores range from 0 (worse) to 100 (best).

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States