Clincosm LogoSign in Get a demo

FoodRx for Obesity Treatment

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05635019
Collaborator
National Institute of Nursing Research (NINR) (NIH)
105
Enrollment
1
Location
3
Arms
20
Anticipated Duration (Months)
5.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BWL+VOUCHER
  • Behavioral: BWL+HOME
  • Behavioral: Behavioral weight loss counseling (BWL)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized clinical trialRandomized clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Food Supplementation Interventions to Improve Weight Loss for Adults With Food Insecurity and Obesity
Actual Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Behavioral weight loss counseling (BWL) alone

BWL counseling alone

Behavioral: 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.
Experimental: BWL+VOUCHER

BWL counseling and gift cards to grocery stores

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.

Behavioral: 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.
Experimental: BWL+HOME

BWL counseling and home-delivered boxes of groceries

Behavioral: 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: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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).

  3. 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).

  4. 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

  5. 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).

  6. 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).

  7. 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).

  8. 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

  9. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

  1. Use of prescription or over the counter medications for chronic weight management in the past 3 months

  2. Household member already participating in study due to potential contamination effects

  3. Lack of stable residence and ability to store and prepare food

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • National Institute of Nursing Research (NINR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05635019
Other Study ID Numbers:
  • 852467
  • R56NR020466-01
First Posted:
Dec 2, 2022
Last Update Posted:
Dec 22, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Pennsylvania
obesity
food insecurity
weight loss
Additional relevant MeSH terms:
Obesity

Study Results

No Results Posted as of Dec 22, 2022