Trial results for the FoodRx for Obesity Treatment study in Obesity were posted on ClinicalTrials.gov on 2025-12-17, showing a mean weight loss of 3.0% in the behavioral weight loss counseling plus food supplementation group at 24 weeks.
Background
Obesity is a complex chronic disease characterized by excessive body fat, posing significant health risks. Behavioral Weight Loss (BWL) counseling is a common approach to manage obesity, focusing on diet and lifestyle changes. However, for individuals also experiencing food insecurity, adhering to dietary recommendations can be challenging due to limited access to nutritious food. This trial explored whether supplementing standard BWL with food resources, such as vouchers or home-delivered medically tailored groceries, could improve weight loss outcomes and other health-related measures in adults with both obesity and food insecurity.
Trial design
This completed study, designated as Phase NA, enrolled 105 adults diagnosed with Obesity and experiencing Food Insecurity. The trial utilized a 3-group, parallel design, randomized controlled trial (RCT) over 24 weeks. Participants were randomized to one of three arms: Behavioral Weight Loss (BWL) Alone (n=35), BWL plus food vouchers (BWL+VOUCHER; n=35), or BWL plus home-delivered, medically tailored groceries (BWL+HOME; n=35). All groups received BWL treatment for 24 weeks according to clinical guidelines. Food vouchers and home-delivered groceries were provided for the 24-week treatment period in their respective arms. The key outcome measured was the percent change in total body weight at 24 weeks.
Key results
The trial results presented several key measurements at 24 weeks:
- Percent Change in Total Body Weight at 24 Weeks:
- Participants receiving Behavioral Weight Loss Counseling (BWL) Alone experienced a mean weight change of -2.7% (Standard Error: 0.5 percent initial weight loss).
- The combined BWL+Supplement group (BWL+VOUCHER or BWL+HOME) showed a mean weight change of -3.0% (Standard Error: 0.3 percent initial weight loss).
- Specifically, the BWL+VOUCHER group achieved a mean weight change of -3.5% (Standard Error: 0.4 percent initial weight loss).
- The BWL+HOME group achieved a mean weight change of -2.7% (Standard Error: 0.5 percent initial weight loss).
- General Health-related Quality of Life:
- The BWL Alone group showed a mean change of -0.5 (Standard Error: 2.0 score on a scale).
- The combined BWL+Supplement group showed a mean change of -0.64 (Standard Error: 1.3 score on a scale).
- Weight-related Quality of Life:
- The BWL Alone group showed a mean change of 7.8 (Standard Error: 2.5 score on a scale).
- The combined BWL+Supplement group showed a mean change of 8.8 (Standard Error: 1.6 score on a scale).
- Dietary Quality as Assessed by Skin Carotenoid Levels:
- The BWL Alone group showed a mean change of 15.6 (Standard Error: 10.3 units on a scale).
- The combined BWL+Supplement group showed a mean change of 7.1 (Standard Error: 6.7 units on a scale).
- Dietary Quality as Assessed by the Healthy Eating Index:
- The BWL Alone group showed a mean change of 0.4 (Standard Error: 3.0 score on a scale).
- The BWL+VOUCHER group showed a mean change of 10.8 (Standard Error: 2.8 score on a scale).
What this means
The results suggest that integrating food supplementation with behavioral weight loss counseling may offer a modest benefit in weight reduction for adults with obesity and food insecurity. The combined BWL+Supplement group achieved a mean weight loss of 3.0%, slightly more than the 2.7% observed in the BWL Alone group. Notably, the BWL+VOUCHER arm demonstrated the highest mean weight loss at 3.5%. While general health-related quality of life changes were minimal across groups, weight-related quality of life showed a slightly higher improvement in the BWL+Supplement group (8.8) compared to BWL Alone (7.8). Dietary quality assessments showed varied outcomes, with the BWL+VOUCHER group showing a substantial increase in Healthy Eating Index score (10.8) compared to BWL Alone (0.4). These findings indicate that addressing food insecurity through supplementation alongside standard behavioral weight loss interventions could be a beneficial strategy, particularly with food vouchers, for improving weight outcomes and dietary quality.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05635019, titled "FoodRx for Obesity Treatment", were posted on 2025-12-17 on clinicaltrials.gov.