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| ID | Type | Description | Link |
|---|---|---|---|
| Approval 11/20/25 | Other Identifier | UW Madison | |
| SMPH/DOM General Internal | Other Identifier | UW Madison |
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The purpose of the research is to evaluate the acceptability and feasibility of implementing a 8-session nutritional education program in a general internal medicine clinic. This program emphasizes a fiber-rich, whole foods diet consisting of fruits, vegetables, legumes, whole grains, nuts and seeds. Such interventions can improve diabetes management and lead to weight loss. 48 participants will be enrolled and on study for approximately 5 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Plate Living Nutrition Education Program | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full Plate Living Nutrition Education Program | Other | Participants will attend 8 sessions over 8 weeks. Participants will learn about the importance of fiber and how to add fiber to their diet. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Weight | retrospectively from 2 years prior to enrollment and up to 20 weeks on study (3 month follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) | Dietary fiber (grams per day) will be measured using the Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) which has been validated for measuring fiber intake in adults. The ASA24 is a free, web-based tool. Participants will complete the ASA24 online two times prior to the first session, 2 times prior to the last session, and 2 times 3 months after the last session. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katie Miller, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| baseline, 8 weeks, 20 weeks (3 month follow up) |
| Participant Quality of Life measured by the SF-12 score | Possible scores range from 0-100 with higher scores indicating better quality of life. | baseline, 8 weeks, 20 weeks (3 month follow up) |
| Acceptability: Percent of Participants who found the intervention acceptable | A subset of participants will be invited to complete an individual interview after the last session. The aim is to schedule 8-12 participants for interviews including both participants who completed all the sessions and those stopped attending sessions. Data will be derived from these qualitative semi-structured interviews. | Participant surveyed at the end of last session, approximately 8 weeks |
| Feasibility: Participant Retention Rate | Feasibility will in part be measured by participant retention rate, the number of participants who complete each time point of data collection over the number of participants enrolled. | baseline, 8 weeks, 20 weeks (3 month follow up) |
| Feasibility: Participation Rate | Feasibility will in part be measured by participation rate, the number of participants enrolled over the target enrollment. | Through enrollment (up to 3 months) |
| D006943 | Hyperglycemia |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |