FoodRx for Obesity Treatment

Food Supplementation Interventions to Improve Weight Loss for Adults With Food Insecurity and Obesity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05635019

Enrollment

105

Registered

2022-12-02

Start date

2022-12-01

Completion date

2024-07-01

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Insecurity, Obesity

Keywords

obesity, food insecurity, weight loss

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.

Interventions

BEHAVIORALBWL+VOUCHER

This group will receive the BWL program as well as food vouchers, in the form of grocery store gift cards. Participants will be allowed to select to receive gift cards to a grocery store or supermarket from a pre-determined list of stores. Gift cards worth $40 will be emailed or mailed to every 2 weeks after the BWL session.

BEHAVIORALBWL+HOME

This group will receive the BWL program as well as home-delivered boxes of groceries of low-energy density foods conducive to weight management guidelines. Groceries will include shelf-stable and perishable products like lean meats, fresh vegetables, and fruits. Every 2 weeks, participants assigned to this group will be allowed to select a choice of one of 4 boxes with slightly varied contents. Each box will have approximately $40 worth of groceries.

BEHAVIORALBehavioral weight loss counseling (BWL)

The behavioral weight loss program consists of 14 individual lifestyle counseling sessions provided over 24 weeks. Each session will be approximately 15-20 minutes. Visits will be scheduled weekly for the first 4 weeks (weeks 1, 2, 3, and 4) and every-other week from weeks 6-24 (weeks 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24). The sessions will provide behavioral, dietary, and physical counseling.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Percent Change in Total Body Weight 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 change (percent of initial weight) at 24 weeks. Positive numbers represent increases and negative numbers represent decreases.

Secondary

Measure	Time frame	Description
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 (physical function component score) 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 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 (skin carotenoids are measured on a scale from 0-800). Lower scores are worse and higher scores indicate a better outcome.
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).
Percent Change in Total Body Weight 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. Negative values indicate losses. Positive values indicate gains.
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 (physical component scale) 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 Skin Carotenoid Levels (BWL+VOUCHER vs BWL+HOME)	Change from baseline to 24 weeks	Change from baseline to week 24 in skin carotenoid levels (skin carotenoids are measured on a scale from 0-800). Lower scores are worse and higher scores indicate a better outcome.
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).
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).

Countries

United States

Participant flow

Pre-assignment details

Phone screen. Interested participants were consented verbally over the phone by study staff to participate in the initial telephone screening. Eligible participants attended a 1.5-hour, in-person screening visit.

Participants by arm

Arm	Count
Behavioral Weight Loss Counseling (BWL) Alone BWL counseling alone	35
BWL+VOUCHER BWL counseling and gift cards to grocery stores	35
BWL+HOME BWL counseling and home-delivered boxes of groceries	35
Total	105

Baseline characteristics

Characteristic	Behavioral Weight Loss Counseling (BWL) Alone	Total	BWL+HOME	BWL+VOUCHER
Age, Continuous	49.7 years STANDARD_DEVIATION 14.8	52.8 years STANDARD_DEVIATION 13.9	53.3 years STANDARD_DEVIATION 15	55.4 years STANDARD_DEVIATION 11.3
Baseline weight (kg)	108.0 kg STANDARD_DEVIATION 17.9	107.7 kg STANDARD_DEVIATION 20.2	110.4 kg STANDARD_DEVIATION 17.1	104.6 kg STANDARD_DEVIATION 24.8
Race (NIH/OMB) American Indian or Alaska Native	2 Participants	3 Participants	1 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	23 Participants	76 Participants	26 Participants	27 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) White	8 Participants	23 Participants	8 Participants	7 Participants
Sex: Female, Male Female	30 Participants	92 Participants	31 Participants	31 Participants
Sex: Female, Male Male	5 Participants	13 Participants	4 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 35	0 / 35	0 / 35
other Total, other adverse events	0 / 35	0 / 35	0 / 35
serious Total, serious adverse events	0 / 35	0 / 35	0 / 35

Outcome results

Primary

Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)

Comparison of BWL+VOUCHER and BWL+HOME vs BWL-Alone in weight change (percent of initial weight) at 24 weeks. Positive numbers represent increases and negative numbers represent decreases.