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| ID | Type | Description | Link |
|---|---|---|---|
| R56NR020466-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral weight loss counseling (BWL) alone | Active Comparator | BWL counseling alone |
|
| BWL+VOUCHER | Experimental | BWL counseling and gift cards to grocery stores |
|
| BWL+HOME | Experimental | BWL counseling and home-delivered boxes of groceries |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BWL+VOUCHER | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone) | 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. | Change from baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Total Body Weight 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. Negative values indicate losses. Positive values indicate gains. | Change from baseline to 24 weeks |
| General Health-related Quality of Life (BWL+VOUCHER and BWL+HOME vs BWL-Alone) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Weight Loss Counseling (BWL) Alone | BWL counseling alone |
| FG001 | BWL+VOUCHER | BWL counseling and gift cards to grocery stores |
| FG002 | BWL+HOME | BWL counseling and home-delivered boxes of groceries |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Weight Loss Counseling (BWL) Alone | BWL counseling alone |
| BG001 | BWL+VOUCHER | BWL counseling and gift cards to grocery stores |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Self-reported age at enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in Total Body Weight at 24 Weeks (BWL+VOUCHER and BWL+HOME vs BWL-Alone) | 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. | Intention-to-treat analysis | Posted | Mean | Standard Error | Percent initial weight loss | Change from baseline to 24 weeks |
|
Baseline to 24 weeks
As per clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Weight Loss Counseling (BWL) Alone | BWL counseling alone | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ariana Chao | University of Pennsylvania and Johns Hopkins University | 443-287-6223 | ariana.chao@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2023 | Jun 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized clinical trial
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|
| BWL+HOME | Behavioral | 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) | Behavioral | 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. |
|
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). |
| Change from baseline to 24 weeks |
| 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 |
| 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 (skin carotenoids are measured on a scale from 0-800). Lower scores are worse and higher scores indicate a better outcome. | Change from baseline to 24 weeks |
| 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 |
| 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 |
| Weight-related Quality of Life (BWL+VOUCHER vs BWL+HOME) | 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). | Change from baseline to 24 weeks |
| Dietary Quality as Assessed by Skin Carotenoid Levels (BWL+VOUCHER vs BWL+HOME) | 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. | Change from baseline to 24 weeks |
| 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 |
| BG002 | BWL+HOME | BWL counseling and home-delivered boxes of groceries |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline weight (kg) | Baseline body weight (kg) | Mean | Standard Deviation | kg |
|
|
|
| Secondary | Percent Change in Total Body Weight 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. Negative values indicate losses. Positive values indicate gains. | Posted | Mean | Standard Error | Percent initial weight loss | 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 (physical function component score) as assessed with the Short Form-36. Scores range from 0 (worse) to 100 (best). | Intention-to-treat | Posted | Mean | Standard Error | score on a scale | 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). | Intention-to-treat | Posted | Mean | Standard Error | score on a scale | 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 (skin carotenoids are measured on a scale from 0-800). Lower scores are worse and higher scores indicate a better outcome. | Intention-to-treat | Posted | Mean | Standard Error | units on a scale | 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). | Posted | Mean | Standard Error | score on a scale | 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). | Intention-to-treat | Posted | Mean | Standard Error | score on a scale | 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 (physical component scale) as assessed with the Impact of Weight on Quality of Life-Lite. Scores range from 0 (worse) to 100 (best). | Intention-to-treat | Posted | Mean | Standard Error | score on a scale | 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 (skin carotenoids are measured on a scale from 0-800). Lower scores are worse and higher scores indicate a better outcome. | Intention-to-treat | Posted | Mean | Standard Error | units on a scale | 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). | Intention to treat | Posted | Mean | Standard Error | score on a scale | Change from baseline to 24 weeks |
|
|
|
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | BWL+VOUCHER | BWL counseling and gift cards to grocery stores | 0 | 35 | 0 | 35 | 0 | 35 |
| EG002 | BWL+HOME | BWL counseling and home-delivered boxes of groceries | 0 | 35 | 0 | 35 | 0 | 35 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |