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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR021699 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The goal of this clinical trial is to learn if increased access to healthy foods, combined with behavioral weight loss (BWL) interventions, results in greater weight loss for adults with obesity and food insecurity. It will also learn about changes in health-quality of life and dietary quality. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BWL-Alone | Active Comparator | Participants receive BWL-Alone |
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| BWL+Voucher | Experimental | Participants receive BWL+Voucher |
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| BWL+Home | Experimental | Participants receive BWL+Home |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BWL | Behavioral | Participants will receive a lifestyle modification program consisting of behavioral, physical activity, and dietary counseling delivered over 21, approximately 15 minute sessions delivered by trained interventionists. Sessions will be weekly during weeks 0-4, every other week during weeks 6-24, monthly during weeks 25-52. Treatment will be delivered remotely. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent initial weight loss at week 24 (BWL+VOUCHER and BWL+HOME to BWL-Alone) | Comparison of BWL+VOUCHER and BWL+HOME to BWL-Alone for weight loss (percent of baseline weight) at 24 weeks | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent initial weight loss at week 24 (BWL+VOUCHER versus BWL+HOME) | Comparison of BWL+VOUCHER versus BWL+HOME for weight loss (percent of baseline weight) at 24 weeks | Baseline to 24 weeks |
| Percent initial weight loss at week 52 (BWL+VOUCHER and BWL+HOME to BWL-Alone) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ariana M Chao, PhD, CRNP, FNP-BC | Contact | 667-208-7078 | ariana.chao@jhu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ariana Chao, PhD, CRNP, FNP-BC | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| VOUCHER | Other | During the initial 24 weeks, participants randomized to this group will receive the BWL program along with food vouchers distributed in the form of grocery store gift cards. Gift cards worth $60 will be emailed to participants every 2 weeks after their BWL session. From weeks 24-52, participants will continue to have monthly counseling sessions. |
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| HOME | Other | During the initial 24 weeks, participants assigned to this group will receive home-delivered, medically tailored groceries alongside BWL. The contents of each box will be approximately $60 ($30/week) and sent using Instacart. From weeks 24-52, participants will continue to have monthly counseling sessions. |
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Comparison of BWL+VOUCHER and BWL+HOME to BWL-Alone for weight loss (percent of baseline weight) at 52 weeks |
| Baseline to 52 weeks |
| Percent initial weight loss at week 52 (BWL+VOUCHER versus BWL+HOME) | Comparison of BWL+VOUCHER versus BWL+HOME for weight loss (percent of baseline weight) at 52 weeks | Baseline to 52 weeks |
| Change from baseline to weeks 24 and 52 in SF-36 Physical Component Score | BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in SF-36 Physical Component Score. Scores range from 0 (lowest) to 100 (highest/best). | Baseline to week 24 and week 52 |
| Change from baseline to weeks 24 and 52 in SF-36 Mental Component Score | BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in SF-36 Mental Component Score. Scores range from 0 (lowest) to 100 (highest/best). | Baseline to week 24 and week 52 |
| Change from baseline to weeks 24 and 52 in total Impact of Weight on Quality of Life scale | BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in total Impact of Weight on Quality of Life scale. Scores range from 0 (lowest) to 100 (highest/best). | Baseline to week 24 and week 52 |
| Change from baseline to weeks 24 and 52 in total Healthy Eating Index score as measured using the Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool | BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in total Health Eating Index score. Scores range from 0 (lowest) to 100 (highest/best which reflect the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines). | Baseline to week 24 and week 52 |
| Change from baseline to weeks 24 and 52 in skin carotenoid levels as measured by the Veggie Meter | BWL-Alone, BWL+VOUCHER, and BWL+HOME in changes from baseline to weeks 24 and 52 in skin carotenoid levels with scores ranging from 0 (lowest) to 800 (highest) | Baseline to week 24 and week 52 |
| Incremental cost-effectiveness per unit decrease in weight (kg) | This measure describes the additional cost required to achieve one kilogram of weight loss with BWL+VOUCHER or BWL+HOME compared with BWL-Alone. It is calculated by dividing the difference in total costs between the two groups by the difference in average weight loss. Lower values indicate that the intervention achieves weight loss at a lower cost. | Baseline to week 24 and week 52 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |