Trial Outcomes & Findings for FoodRx for Obesity Treatment (NCT NCT05635019)

NCT ID: NCT05635019

Last Updated: 2025-12-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

Change from baseline to 24 weeks

Results posted on

2025-12-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Behavioral Weight Loss Counseling (BWL) Alone BWL counseling alone	BWL+VOUCHER BWL counseling and gift cards to grocery stores	BWL+HOME BWL counseling and home-delivered boxes of groceries
Overall Study STARTED	35	35	35
Overall Study COMPLETED	35	35	35
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FoodRx for Obesity Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+VOUCHER n=35 Participants BWL counseling and gift cards to grocery stores	BWL+HOME n=35 Participants BWL counseling and home-delivered boxes of groceries	Total n=105 Participants Total of all reporting groups
Age, Continuous	49.7 years STANDARD_DEVIATION 14.8 • n=6 Participants	55.4 years STANDARD_DEVIATION 11.3 • n=5 Participants	53.3 years STANDARD_DEVIATION 15.0 • n=5 Participants	52.8 years STANDARD_DEVIATION 13.9 • n=122 Participants
Sex: Female, Male Female	30 Participants n=6 Participants	31 Participants n=5 Participants	31 Participants n=5 Participants	92 Participants n=122 Participants
Sex: Female, Male Male	5 Participants n=6 Participants	4 Participants n=5 Participants	4 Participants n=5 Participants	13 Participants n=122 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=6 Participants	0 Participants n=5 Participants	1 Participants n=5 Participants	3 Participants n=122 Participants
Race (NIH/OMB) Asian	1 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=122 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=122 Participants
Race (NIH/OMB) Black or African American	23 Participants n=6 Participants	27 Participants n=5 Participants	26 Participants n=5 Participants	76 Participants n=122 Participants
Race (NIH/OMB) White	8 Participants n=6 Participants	7 Participants n=5 Participants	8 Participants n=5 Participants	23 Participants n=122 Participants
Race (NIH/OMB) More than one race	1 Participants n=6 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=122 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants	1 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=122 Participants
Baseline weight (kg)	108.0 kg STANDARD_DEVIATION 17.9 • n=6 Participants	104.6 kg STANDARD_DEVIATION 24.8 • n=5 Participants	110.4 kg STANDARD_DEVIATION 17.1 • n=5 Participants	107.7 kg STANDARD_DEVIATION 20.2 • n=122 Participants

PRIMARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Intention-to-treat analysis

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.

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=70 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME BWL counseling and home-delivered boxes of groceries
Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	-2.7 Percent initial weight loss Standard Error 0.5	-3.0 Percent initial weight loss Standard Error 0.3	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=35 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME BWL counseling and home-delivered boxes of groceries
Percent Change in Total Body Weight at 24 Weeks (BWL+HOME vs BWL+VOUCHER)	-3.5 Percent initial weight loss Standard Error 0.4	-2.7 Percent initial weight loss Standard Error 0.5	—

SECONDARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Intention-to-treat

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).

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=35 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME BWL counseling and home-delivered boxes of groceries
General Health-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	-0.5 score on a scale Standard Error 2.0	-0.64 score on a scale Standard Error 1.3	—

SECONDARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Intention-to-treat

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).

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=35 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME BWL counseling and home-delivered boxes of groceries
Weight-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	7.8 score on a scale Standard Error 2.5	8.8 score on a scale Standard Error 1.6	—

SECONDARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=35 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME BWL counseling and home-delivered boxes of groceries
Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	15.6 units on a scale Standard Error 10.3	7.1 units on a scale Standard Error 6.7	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=35 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME n=35 Participants BWL counseling and home-delivered boxes of groceries
Dietary Quality as Assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	0.4 score on a scale Standard Error 3.0	10.8 score on a scale Standard Error 2.8	.8 score on a scale Standard Error 2.8

SECONDARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Intention-to-treat

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).

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=35 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME BWL counseling and home-delivered boxes of groceries
General Health-related Quality of Life (BWL+VOUCHER vs BWL+HOME)	0.4 score on a scale Standard Error 1.8	-1.6 score on a scale Standard Error 1.8	—

SECONDARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Intention-to-treat

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).

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=35 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME BWL counseling and home-delivered boxes of groceries
Weight-related Quality of Life (BWL+VOUCHER vs BWL+HOME)	0.4 score on a scale Standard Error 1.8	-1.6 score on a scale Standard Error 1.8	—

SECONDARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Intention-to-treat

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.

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=35 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME BWL counseling and home-delivered boxes of groceries
Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER vs BWL+HOME)	16.2 units on a scale Standard Error 8.6	-1.6 units on a scale Standard Error 8.5	—

SECONDARY outcome

Timeframe: Change from baseline to 24 weeks

Population: Intention to treat

Change from baseline to week 24 in Healthy Eating Index scores as measured with the ASA24. Scores range from 0 (worse) to 100 (best).

Outcome measures

Outcome measures
Measure	Behavioral Weight Loss Counseling (BWL) Alone n=35 Participants BWL counseling alone	BWL+Supplement (BWL+VOUCHER or BWL+HOME) n=35 Participants BWL counseling and gift cards to grocery stores or BWL counseling and home-delivered boxes of groceries	BWL+HOME BWL counseling and home-delivered boxes of groceries
Dietary Quality as Assessed by the Healthy Eating Index (BWL+VOUCHER vs BWL+HOME)	10.8 score on a scale Standard Error 2.8	.8 score on a scale Standard Error 2.8	—

Adverse Events

Behavioral Weight Loss Counseling (BWL) Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BWL+VOUCHER

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

BWL+HOME

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ariana Chao

University of Pennsylvania and Johns Hopkins University

Phone: 443-287-6223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place