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| ID | Type | Description | Link |
|---|---|---|---|
| K01DK119166 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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In this pilot trial participants will be randomized 1:1 to participate in either standard Diabetes Prevention Program (DPP) vs. DPP plus a novel cooking skills intervention (DPP Cooks). The researchers hypothesize that participants randomized to DPP Cooks will have greater weight loss, better diet quality at 4 months, and greater confidence in their cooking skills and ability to implement dietary changes recommended in the DPP.
This study is a randomized pilot trial testing a novel cooking skills intervention (DPP Cooks) vs. the standard Diabetes Prevention Program (DPP). The DPP is a widely disseminated evidenced-based lifestyle behavior change program to help adults with pre-diabetes lose weight and prevent type-2 diabetes. In this trial the investigators will test whether the addition of food-agency based cooking skills classes improves the effectiveness of the DPP. This trial will take place in Baltimore, MD in collaboration with community partner DPP providers. The trial has been informed by formative work with prior DPP participants and has used a Community Based Participatory Research (CBPR) approach to developing the DPP Cooks intervention. Participants will be randomized 1:1 to participate in either standard DPP vs. DPP Cooks. The length of the trial will be 12 months and outcomes will be measured at baseline, 4 months, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard DPP | Active Comparator | Standard DPP (over 12 months) |
|
| DPP Cooks | Experimental | Standard DPP plus DPP Cooks (over 12 months, with 6 active cooking sessions during the first 4 months) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPP Cooks | Behavioral | 6 'food agency' based cooking skills classes during the first 4 months of the DPP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Absolute Body Weight (Kilograms (kg)) | Weight change will be measured in absolute kg. Weight will be measured at baseline, 4 months and 12 months. Weight will be measured by DPP coaches at weekly meetings (or, if DPP groups are meeting virtually, weight will be reported by participants to their DPP coaches in weekly virtual meetings). | baseline, 4 months and 12 months |
| Change From Baseline in Percentage of Baseline Bodyweight | Weight change will be measured in the percent of body weight change. Weight will be measured at baseline, 4 months and 12 months. Weight will be measured by DPP coaches at weekly meetings (or, if DPP groups are meeting virtually, weight will be reported by participants to their DPP coaches in weekly virtual meetings). | baseline, 4 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference From Baseline in Diet Quality (Healthy Eating Index- 2015) Score | Dietary intake and diet quality (Healthy Eating Index (HEI-2015) as measured by the Remote Food Photography Method (RFPM) over 3 days of dietary intake at baseline and 4 months. The HEI-2015 is a score from 0-100 with high score indicating better diet quality. The HEI-2015 measures how well an individuals dietary intake aligns with the 2015 US Dietary Guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Program Attendance Among DPP and DPP Cooks Participants | DPP coaches will report weekly session attendance for all trial participants. Attendance at a higher number of sessions will be a favorable result. | 12 months |
| Program Satisfaction Among DPP Cooks Participants (Qualitative) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia A Wolfson, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brancati Center | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard DPP | Standard DPP (over 12 months) DPP: Standard DPP |
| FG001 | DPP Cooks | Standard DPP plus DPP Cooks (over 12 months, with 6 active cooking sessions during the first 4 months) DPP Cooks: 6 'food agency' based cooking skills classes during the first 4 months of the DPP |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
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| Baseline Data Collection |
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| 4 Month Data Collection |
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| 12 Month Data Collection |
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participants who had baseline data collected
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard DPP | Standard DPP (over 12 months) DPP: Standard DPP |
| BG001 | DPP Cooks | Standard DPP plus DPP Cooks (over 12 months, with 6 active cooking sessions during the first 4 months) DPP Cooks: 6 'food agency' based cooking skills classes during the first 4 months of the DPP |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline in Absolute Body Weight (Kilograms (kg)) | Weight change will be measured in absolute kg. Weight will be measured at baseline, 4 months and 12 months. Weight will be measured by DPP coaches at weekly meetings (or, if DPP groups are meeting virtually, weight will be reported by participants to their DPP coaches in weekly virtual meetings). | Change from baseline to 4 months includes the 29 individuals who completed 4 month data collection. Change from baseline to 12 months includes the 24 individuals who completed 12 month data collection. | Posted | Mean | Standard Error | kg | baseline, 4 months and 12 months |
|
Up to 1 year
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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 | Standard DPP | Standard DPP (over 12 months) DPP: Standard DPP | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julia Wolfson | Johns Hopkins Bloomberg School of Public Health | 410-614-4907 | jwolfso7@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 | Jan 5, 2022 | Oct 16, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2022 | Jan 19, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| DPP | Behavioral | Standard DPP |
|
| Baseline and at 4 months |
| Change From Baseline in Cooking Confidence | Cooking confidence, attitudes and behaviors will be measured via online survey (7- point Likert Scale (strongly agree to strongly disagree) questions) at baseline, 4 months and 12 months. Survey items were based on prior literature, but there is not a formal named scale that was used. Cooking confidence was assessed by 7 items all measured on a 7 point Likert scale. Negative items were reverse coded, then 7 confidence items were summed to create a overall confidence score (range 7-49) with higher values indicating higher confidence. | baseline, 4 months and 12 months |
| Change From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS) | The Cooking and Food Provisioning Action Scale (CAFPAS) is a 28 question scale in which higher scores indicate higher Food Agency. All questions in the CAFPAS are measured on 7-point Likert Scales (strongly agree to strongly disagree). The CAFPAS has 3 sub-scales which are scored by summing the scores on each individual question (after reverse coding negative items) and are then standardized. Then the 3 standardized sub-scale scores are summed to generate an overall CAFPAS score in which higher scores indicate better Food Agency. In this sample scores range from 10.48- 22.25 points with higher scores indicating better Food Agency. | baseline, 4 months and 12 months |
| Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module | The USDA Adult Food Security Survey Module is a 10-item progressive survey instrument in which individuals are asked about the food situation in their household over the last 30 days. Scores are summed and generate the following categories: High food security status (raw score: 0), Marginal food security status (raw score: 1-2), Low food security status (raw score 3-5), Very low food security status (raw score: 6-10). | baseline, 4 months and 12 months |
| Change From Baseline in Cooking Attitudes | Cooking confidence, attitudes and behaviors will be measured via online survey (7- point Likert Scale (strongly agree to strongly disagree) questions) at baseline, 4 months and 12 months. Survey items were based on prior literature, but there is not a formal named scale that was used. Attitudes were assessed by 11 questions all scored on a 7 point Likert scale. Negative attitudes were reverse coded, then scores were summed across all 11 items to create an overall Attitudes score (range: 7-77) with higher scores indicating more positive attitudes about cooking. | baseline, 4 months and 12 months |
| Change From Baseline in Cooking Behavior (Days Cooking Dinner) | Cooking confidence, attitudes and behaviors will be measured via online survey (7- point Likert Scale (strongly agree to strongly disagree) questions) at baseline, 4 months and 12 months. To assess behavior change, an item from the National Health an Nutrition Examination Survey (NHANES) assessing frequency of cooking dinner was used. Change in number of days (0-7) cooking is reported with higher numbers indicating more frequent cooking dinner at home. | baseline, 4 months and 12 months |
Investigators will use interviews or focus groups with DPP Cooks participants to gather qualitative feedback about program satisfaction among participants |
| 12 months |
| DPP Session 1 |
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| COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
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Standard DPP plus DPP Cooks (over 12 months, with 6 active cooking sessions during the first 4 months) DPP Cooks: 6 'food agency' based cooking skills classes during the first 4 months of the DPP |
|
|
| Primary | Change From Baseline in Percentage of Baseline Bodyweight | Weight change will be measured in the percent of body weight change. Weight will be measured at baseline, 4 months and 12 months. Weight will be measured by DPP coaches at weekly meetings (or, if DPP groups are meeting virtually, weight will be reported by participants to their DPP coaches in weekly virtual meetings). | Change from baseline to 4 months includes the 29 individuals who completed 4 month data collection. Change from baseline to 12 months includes the 24 individuals who completed 12 month data collection. | Posted | Mean | Standard Error | percentage of body weight | baseline, 4 months and 12 months |
|
|
|
| Secondary | Difference From Baseline in Diet Quality (Healthy Eating Index- 2015) Score | Dietary intake and diet quality (Healthy Eating Index (HEI-2015) as measured by the Remote Food Photography Method (RFPM) over 3 days of dietary intake at baseline and 4 months. The HEI-2015 is a score from 0-100 with high score indicating better diet quality. The HEI-2015 measures how well an individuals dietary intake aligns with the 2015 US Dietary Guidelines. | all individuals with data at baseline and 4 months | Posted | Mean | Standard Error | score on a scale | Baseline and at 4 months |
|
|
|
| Secondary | Change From Baseline in Cooking Confidence | Cooking confidence, attitudes and behaviors will be measured via online survey (7- point Likert Scale (strongly agree to strongly disagree) questions) at baseline, 4 months and 12 months. Survey items were based on prior literature, but there is not a formal named scale that was used. Cooking confidence was assessed by 7 items all measured on a 7 point Likert scale. Negative items were reverse coded, then 7 confidence items were summed to create a overall confidence score (range 7-49) with higher values indicating higher confidence. | Change from baseline to 4 months includes the 29 individuals who completed 4 month data collection. Change from baseline to 12 months includes the 24 individuals who completed 12 month data collection. | Posted | Mean | Standard Error | units on a scale | baseline, 4 months and 12 months |
|
|
|
| Secondary | Change From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS) | The Cooking and Food Provisioning Action Scale (CAFPAS) is a 28 question scale in which higher scores indicate higher Food Agency. All questions in the CAFPAS are measured on 7-point Likert Scales (strongly agree to strongly disagree). The CAFPAS has 3 sub-scales which are scored by summing the scores on each individual question (after reverse coding negative items) and are then standardized. Then the 3 standardized sub-scale scores are summed to generate an overall CAFPAS score in which higher scores indicate better Food Agency. In this sample scores range from 10.48- 22.25 points with higher scores indicating better Food Agency. | Change from baseline to 4 months includes the 29 individuals who completed 4 month data collection. Change from baseline to 12 months includes the 24 individuals who completed 12 month data collection. | Posted | Mean | Standard Error | change in score on a scale | baseline, 4 months and 12 months |
|
|
|
| Secondary | Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module | The USDA Adult Food Security Survey Module is a 10-item progressive survey instrument in which individuals are asked about the food situation in their household over the last 30 days. Scores are summed and generate the following categories: High food security status (raw score: 0), Marginal food security status (raw score: 1-2), Low food security status (raw score 3-5), Very low food security status (raw score: 6-10). | Analyzed among all participants enrolled and at each time point. One participant still enrolled at 12 months was missing data for food insecurity. | Posted | Count of Participants | Participants | baseline, 4 months and 12 months |
|
|
|
| Secondary | Change From Baseline in Cooking Attitudes | Cooking confidence, attitudes and behaviors will be measured via online survey (7- point Likert Scale (strongly agree to strongly disagree) questions) at baseline, 4 months and 12 months. Survey items were based on prior literature, but there is not a formal named scale that was used. Attitudes were assessed by 11 questions all scored on a 7 point Likert scale. Negative attitudes were reverse coded, then scores were summed across all 11 items to create an overall Attitudes score (range: 7-77) with higher scores indicating more positive attitudes about cooking. | Change from baseline to 4 months includes the 29 individuals who completed 4 month data collection. Change from baseline to 12 months includes the 24 individuals who completed 12 month data collection. | Posted | Mean | Standard Error | units on a scale | baseline, 4 months and 12 months |
|
|
|
| Secondary | Change From Baseline in Cooking Behavior (Days Cooking Dinner) | Cooking confidence, attitudes and behaviors will be measured via online survey (7- point Likert Scale (strongly agree to strongly disagree) questions) at baseline, 4 months and 12 months. To assess behavior change, an item from the National Health an Nutrition Examination Survey (NHANES) assessing frequency of cooking dinner was used. Change in number of days (0-7) cooking is reported with higher numbers indicating more frequent cooking dinner at home. | Change from baseline to 4 months includes the 29 individuals who completed 4 month data collection. Change from baseline to 12 months includes the 24 individuals who completed 12 month data collection. | Posted | Mean | Standard Error | days | baseline, 4 months and 12 months |
|
|
|
| Other Pre-specified | Program Attendance Among DPP and DPP Cooks Participants | DPP coaches will report weekly session attendance for all trial participants. Attendance at a higher number of sessions will be a favorable result. | Not Posted | 12 months | Participants |
| Other Pre-specified | Program Satisfaction Among DPP Cooks Participants (Qualitative) | Investigators will use interviews or focus groups with DPP Cooks participants to gather qualitative feedback about program satisfaction among participants | Not Posted | 12 months | Participants |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | DPP Cooks | Standard DPP plus DPP Cooks (over 12 months, with 6 active cooking sessions during the first 4 months) DPP Cooks: 6 'food agency' based cooking skills classes during the first 4 months of the DPP | 0 | 23 | 0 | 23 | 0 | 23 |
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| change from baseline to 12 months |
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| change from baseline to 12 months |
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| change from baseline to 12 months |
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| Marginal food security |
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| Low food security |
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| Very low food security |
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| 4 months |
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| 12 months |
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| change from baseline to 12 months |
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| change from baseline to 12 months |
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