FoodRx for Obesity Treatment

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05635019
• Other study ID #: 852467
• Secondary ID: R56NR020466-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Food Insecurity
• Obesity

Intervention

Behavioral:
• BWL+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.
• BWL+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.
• Behavioral 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent initial weight loss at 24 weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	Comparison of BWL+VOUCHER and BWL+HOME vs BWL-Alone in weight loss (percent of initial weight) at 24 weeks.	Change from baseline to 24 weeks
Secondary	Percent initial weight loss at 24 weeks (BWL+HOME vs BWL+VOUCHER)	Comparison of BWL+HOME vs BWL+VOUCHER in weight loss (percent of initial weight) at 24 weeks.	Change from baseline to 24 weeks
Secondary	General health-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	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).	Change from baseline to 24 weeks
Secondary	Weight-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	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).	Change from baseline to 24 weeks
Secondary	Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	Change from baseline to week 24 in skin carotenoid levels	Change from baseline to 24 weeks
Secondary	Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone)	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).	Change from baseline to 24 weeks
Secondary	General health-related quality of life (BWL+VOUCHER vs BWL+HOME)	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).	Change from baseline to 24 weeks
Secondary	Weight-related quality of life (BWL+VOUCHER vs BWL+HOME)	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).	Change from baseline to 24 weeks
Secondary	Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER vs BWL+HOME)	Change from baseline to week 24 in skin carotenoid levels	Change from baseline to 24 weeks
Secondary	Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER vs BWL+HOME)	Change from baseline to week 24 in Healthy Eating Index scores as measured with the ASA24. Scores range from 0 (worse) to 100 (best).	Change from baseline to 24 weeks