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FoodRx for Obesity Treatment

Primary Purpose

Obesity, Food Insecurity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BWL+VOUCHER
BWL+HOME
Behavioral weight loss counseling (BWL)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, food insecurity, weight loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Age >18 years BMI >30 kg/m2 at screening visit Screening positive for food insecurity using a score of >3 on the 10-item US Adult Food Security Survey Module109 Completion of baseline assessments Ability to engage in physical activity (i.e., can walk at least 2 blocks) Willing and able to provide pictures of food receipts to study team (or mail actual receipts) Ability to reliably receive packages at a consistent location in a timely manner Telephone or internet service to communicate with study staff For females of reproductive potential: agreement to use of highly effective contraception for during study participation Exclusion Criteria: 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 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 Breastfeeding, pregnant or planning pregnancy in the next 6 months Planned move from the Philadelphia area in the next 6 months Weight loss of >5 kg in the previous 90 days Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg) Previous or planned obesity treatment with surgery (excluding lap band if removed for >1 year) or a weight-loss device Use of prescription or over the counter medications for chronic weight management in the past 3 months Household member already participating in study due to potential contamination effects Lack of stable residence and ability to store and prepare food

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Behavioral weight loss counseling (BWL) alone

BWL+VOUCHER

BWL+HOME

Arm Description

BWL counseling alone

BWL counseling and gift cards to grocery stores

BWL counseling and home-delivered boxes of groceries

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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).
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
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).
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).
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).
Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER vs BWL+HOME)
Change from baseline to week 24 in skin carotenoid levels
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).

Full Information

First Posted
November 22, 2022
Last Updated
December 19, 2022
Sponsor
University of Pennsylvania
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT05635019
Brief Title
FoodRx for Obesity Treatment
Official Title
Food Supplementation Interventions to Improve Weight Loss for Adults With Food Insecurity and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Food Insecurity
Keywords
obesity, food insecurity, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral weight loss counseling (BWL) alone
Arm Type
Active Comparator
Arm Description
BWL counseling alone
Arm Title
BWL+VOUCHER
Arm Type
Experimental
Arm Description
BWL counseling and gift cards to grocery stores
Arm Title
BWL+HOME
Arm Type
Experimental
Arm Description
BWL counseling and home-delivered boxes of groceries
Intervention Type
Behavioral
Intervention Name(s)
BWL+VOUCHER
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BWL+HOME
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight loss counseling (BWL)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent initial weight loss at 24 weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
Description
Comparison of BWL+VOUCHER and BWL+HOME vs BWL-Alone in weight loss (percent of initial weight) at 24 weeks.
Time Frame
Change from baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Percent initial weight loss at 24 weeks (BWL+HOME vs BWL+VOUCHER)
Description
Comparison of BWL+HOME vs BWL+VOUCHER in weight loss (percent of initial weight) at 24 weeks.
Time Frame
Change from baseline to 24 weeks
Title
General health-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
Description
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).
Time Frame
Change from baseline to 24 weeks
Title
Weight-related quality of life (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
Description
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).
Time Frame
Change from baseline to 24 weeks
Title
Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
Description
Change from baseline to week 24 in skin carotenoid levels
Time Frame
Change from baseline to 24 weeks
Title
Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER and BWL+HOME vs BWL-Alone)
Description
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).
Time Frame
Change from baseline to 24 weeks
Title
General health-related quality of life (BWL+VOUCHER vs BWL+HOME)
Description
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).
Time Frame
Change from baseline to 24 weeks
Title
Weight-related quality of life (BWL+VOUCHER vs BWL+HOME)
Description
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).
Time Frame
Change from baseline to 24 weeks
Title
Dietary quality as assessed by skin carotenoid levels (BWL+VOUCHER vs BWL+HOME)
Description
Change from baseline to week 24 in skin carotenoid levels
Time Frame
Change from baseline to 24 weeks
Title
Dietary quality as assessed by the Healthy Eating Index (BWL+VOUCHER vs BWL+HOME)
Description
Change from baseline to week 24 in Healthy Eating Index scores as measured with the ASA24. Scores range from 0 (worse) to 100 (best).
Time Frame
Change from baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Age >18 years BMI >30 kg/m2 at screening visit Screening positive for food insecurity using a score of >3 on the 10-item US Adult Food Security Survey Module109 Completion of baseline assessments Ability to engage in physical activity (i.e., can walk at least 2 blocks) Willing and able to provide pictures of food receipts to study team (or mail actual receipts) Ability to reliably receive packages at a consistent location in a timely manner Telephone or internet service to communicate with study staff For females of reproductive potential: agreement to use of highly effective contraception for during study participation Exclusion Criteria: 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 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 Breastfeeding, pregnant or planning pregnancy in the next 6 months Planned move from the Philadelphia area in the next 6 months Weight loss of >5 kg in the previous 90 days Recently began a course of or changed the dosage of medication that can cause significant weight change (±5 kg) Previous or planned obesity treatment with surgery (excluding lap band if removed for >1 year) or a weight-loss device Use of prescription or over the counter medications for chronic weight management in the past 3 months Household member already participating in study due to potential contamination effects Lack of stable residence and ability to store and prepare food
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariana M Chao, PhD, CRNP
Phone
215-746-7183
Email
arichao@upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Paul
Phone
215-573-7403
Email
Alex.Paul@Pennmedicine.upenn.edu

12. IPD Sharing Statement

Learn more about this trial

FoodRx for Obesity Treatment

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