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This study experimentally investigates 1) whether ultra processed food (UPF) intake contributes to depression by increasing low mood and poor sleep due to blood glucose fluctuations (which then increases the desire to consume more UPFs) and 2) to investigate the effectiveness of a 2-week meal-kit intervention that provides convenient and tasty minimally processed foods (MPF) to reduce depression. The following aims and hypotheses are tested:
Aim 1: To investigate whether UPF intake and low mood contribute to each other in a cyclical fashion through the mechanisms of blood glucose fluctuations and disrupted sleep in individuals with moderate-to-severe depression.
H1: It is hypothesized that UPF intake and high blood glucose will be associated with low mood in individuals with depression.
Aim 2: To establish an industry partnership to investigate whether commercially available meal kit delivery reduces symptoms of depression in individuals with moderate-to-severe depression relative to a nutrition education control condition.
H2: Meal kit delivery will lead to reductions in depression symptoms and daily reductions in low mood relative to the control condition (nutrition guidance only).
The study will include a combination of in-person, at-home, and virtual activities over the course of ~21 days (contingent on scheduling, this duration may vary and particularly between in-person visits #1 and #2). Participants complete three in-lab visits, each followed by a week of remote data tasks (e.g., ecological momentary assessment, continuous glucose monitoring, and physical activity and sleep tracking (Fitbit)).
During in-lab visit #1, participants will complete questionnaires and interviews, have a continuous glucose monitor inserted, and will have body composition measurements taken (height, weight, Inbody scan). Participants will complete the remote tasks for the following week while eating their typical diet (i.e., baseline period).
During in-lab visit #2, participants will complete questionnaires, interviews, and body composition measurements (height, weight, Inbody scan). Participants are randomly assigned to a meal delivery (will receive two weeks of low UPF meals and nutrition guidance) or control (will receive some snacks and nutrition guidance) condition (i.e., dietary intervention period). Participants will complete the remote tasks for the following two weeks.
During in-lab visit #3, participants will complete questionnaires, interviews, and body composition measurements (height, weight, InBody scan).
Participants are contacted 1- and 6-months later to complete a short follow-up survey and provide information about their current diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal Delivery | Experimental | Dietary change (low ultra-processed meal delivery) and nutrition guidance to follow a low UPF diet. All participants complete a series of three in-lab visits with remote data collection: Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following 2 weeks comprise the dietary intervention period. Meal delivery and nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet. Visit 3 comprises post-intervention assessment All participants will complete remote assessments at 1 month and 6 month follow-ups. |
|
| Nutritional Guidance | Experimental | Dietary change (nutritional guidance) Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following week comprise the dietary intervention period. Nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet. Participants are delivered a box of snacks consistent with a low UPF diet. Visit 3 comprises post-intervention assessment. All participants will complete remote assessments at 1 month and 6 month follow ups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low UPF Meals (Study Provided) | Other | Meals provided through delivery service |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Low mood symptoms | Depression symptoms (e.g., anhedonia, low energy) will be assessed with the Patient Health Questionnaire (PHQ-8) using ecological momentary assessment and at each study visit. The PHQ-8 scores 8 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Higher PHQ-8 scores indicate greater depression symptoms. | Assessed during dietary adherence period for 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Level | Assessed using a continuous blood glucose monitor | Assessed during dietary adherence period for 2 weeks |
| Sleep Quality | Assessed using a Fitbit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42177608 | Derived | Worth IA, Furman CR, Li KR, Sonneville KR, Gearhardt AN. Examining the effects of two dietary intervention approaches on disordered eating-related thoughts and behaviors in adults with moderate to moderately severe depressive symptoms. J Eat Disord. 2026 May 23. doi: 10.1186/s40337-026-01640-8. Online ahead of print. |
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This research will generate demographic, heart rate, ecological momentary assessment, continuous glucose monitoring, self-report and anthropometric data. The data will be stored as SPSS or SAS files. Meta data will also be included in the selected repositories. The metadata will include the data dictionaries, which describe the generation of all variables. The deidentified data will be made available within one year of completion of the study at the University of Michigan's data repository - Deep Blue.
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Beginning 1 year and ending 7 years following article publication
Researchers who provide a methodologically sound proposal will be able to access data to achieve aims outlined in the approved proposal. Proposals should be directed to agearhar@umich.edu to gain access. Data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Multi-method, mixed-design
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Participants will be blinded to their condition.
| Low UPF Nutritional Guidance |
| Other |
Self-guided instructions from study team. |
|
| Low UPF Snacks (Study Provided) | Other | Low UPF snacks provided to participant |
|
| Assessed during dietary adherence period for 2 weeks |
| Metabolic Equivalent of Task (METs) | A measure of physical activity engagement assessed using a Fitbit | Assessed during dietary adherence period for 2 weeks |
| Feasibility of the Interventions | Assessed in a qualitative interview at Visit 3 | Assessed post-dietary change during in-lab Visit 3 (1 day) |
| Accessibility of the Interventions | Assessed in a qualitative interview at Visit 3 | Assessed post-dietary change during in-lab Visit 3 (1 day) |