Trial Outcomes & Findings for Pilot Trial of a Novel Cooking Skills Intervention (DPPCooks) to Prevent Diabetes (NCT NCT05166512)
NCT ID: NCT05166512
Last Updated: 2024-11-22
Results Overview
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).
COMPLETED
NA
45 participants
baseline, 4 months and 12 months
2024-11-22
Participant Flow
Participant milestones
| Measure |
Standard DPP
Standard DPP (over 12 months)
DPP: Standard DPP
|
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
|
|---|---|---|
|
Randomized
STARTED
|
22
|
23
|
|
Randomized
COMPLETED
|
19
|
23
|
|
Randomized
NOT COMPLETED
|
3
|
0
|
|
Baseline Data Collection
STARTED
|
19
|
23
|
|
Baseline Data Collection
DPP Session 0
|
19
|
23
|
|
Baseline Data Collection
DPP Session 1
|
18
|
20
|
|
Baseline Data Collection
COMPLETED
|
16
|
20
|
|
Baseline Data Collection
NOT COMPLETED
|
3
|
3
|
|
4 Month Data Collection
STARTED
|
16
|
20
|
|
4 Month Data Collection
COMPLETED
|
14
|
15
|
|
4 Month Data Collection
NOT COMPLETED
|
2
|
5
|
|
12 Month Data Collection
STARTED
|
14
|
15
|
|
12 Month Data Collection
COMPLETED
|
10
|
14
|
|
12 Month Data Collection
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Standard DPP
Standard DPP (over 12 months)
DPP: Standard DPP
|
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
|
|---|---|---|
|
Randomized
Lost to Follow-up
|
2
|
0
|
|
Randomized
Withdrawal by Subject
|
1
|
0
|
|
Baseline Data Collection
Lost to Follow-up
|
0
|
3
|
|
Baseline Data Collection
Withdrawal by Subject
|
1
|
0
|
|
Baseline Data Collection
Protocol Violation
|
2
|
0
|
|
4 Month Data Collection
Lost to Follow-up
|
1
|
0
|
|
4 Month Data Collection
Withdrawal by Subject
|
1
|
5
|
|
12 Month Data Collection
Lost to Follow-up
|
3
|
1
|
|
12 Month Data Collection
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Pilot Trial of a Novel Cooking Skills Intervention (DPPCooks) to Prevent Diabetes
Baseline characteristics by cohort
| Measure |
Standard DPP
n=16 Participants
Standard DPP (over 12 months)
DPP: Standard DPP
|
DPP Cooks
n=20 Participants
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
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 17.2 • n=7 Participants
|
55.9 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Education
some high school
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
high school
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education
some college
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education
college graduate
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Marital Status
single
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Marital Status
married
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Marital Status
living with partner
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Marital Status
divorced, separated, widowed
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Income
<$35,000/ year
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Income
#35,000-$59,000/ year
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Income
$60,000-$85,000/ year
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Income
>$85,000/ year
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 4 months and 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Standard DPP
n=14 Participants
Standard DPP (over 12 months)
DPP: Standard DPP
|
DPP Cooks
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Absolute Body Weight (Kilograms (kg))
change from baseline to 4 months
|
-2.12 kg
Standard Error 1.61
|
-1.00 kg
Standard Error 1.55
|
|
Change From Baseline in Absolute Body Weight (Kilograms (kg))
change from baseline to 12 months
|
-5.27 kg
Standard Error 1.67
|
-4.15 kg
Standard Error 1.57
|
PRIMARY outcome
Timeframe: baseline, 4 months and 12 monthsPopulation: 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.
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).
Outcome measures
| Measure |
Standard DPP
n=14 Participants
Standard DPP (over 12 months)
DPP: Standard DPP
|
DPP Cooks
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Percentage of Baseline Bodyweight
change from baseline to 12 months
|
-5.12 percentage of body weight
Standard Error 1.55
|
-4.11 percentage of body weight
Standard Error 1.46
|
|
Change From Baseline in Percentage of Baseline Bodyweight
change from baseline to 4 months
|
-1.96 percentage of body weight
Standard Error 1.49
|
-0.95 percentage of body weight
Standard Error 1.44
|
SECONDARY outcome
Timeframe: Baseline and at 4 monthsPopulation: all individuals with data at baseline and 4 months
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.
Outcome measures
| Measure |
Standard DPP
n=14 Participants
Standard DPP (over 12 months)
DPP: Standard DPP
|
DPP Cooks
n=15 Participants
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
|
|---|---|---|
|
Difference From Baseline in Diet Quality (Healthy Eating Index- 2015) Score
|
1.52 score on a scale
Standard Error 3.50
|
-2.81 score on a scale
Standard Error 3.37
|
SECONDARY outcome
Timeframe: baseline, 4 months and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Standard DPP
n=14 Participants
Standard DPP (over 12 months)
DPP: Standard DPP
|
DPP Cooks
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Cooking Confidence
change from baseline to 4 months
|
0.84 units on a scale
Standard Error 1.37
|
0.47 units on a scale
Standard Error 1.31
|
|
Change From Baseline in Cooking Confidence
change from baseline to 12 months
|
1.84 units on a scale
Standard Error 1.44
|
1.46 units on a scale
Standard Error 1.33
|
SECONDARY outcome
Timeframe: baseline, 4 months and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Standard DPP
n=14 Participants
Standard DPP (over 12 months)
DPP: Standard DPP
|
DPP Cooks
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)
change from baseline to 4 months
|
0.16 change in score on a scale
Standard Error 0.42
|
-0.53 change in score on a scale
Standard Error 0.41
|
|
Change From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)
change from baseline to 12 months
|
0.93 change in score on a scale
Standard Error 0.44
|
0.24 change in score on a scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: baseline, 4 months and 12 monthsPopulation: Analyzed among all participants enrolled and at each time point. One participant still enrolled at 12 months was missing data for food insecurity.
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).
Outcome measures
| Measure |
Standard DPP
n=16 Participants
Standard DPP (over 12 months)
DPP: Standard DPP
|
DPP Cooks
n=20 Participants
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
|
|---|---|---|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
4 months · High food security
|
10 Participants
|
6 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
4 months · Marginal food security
|
3 Participants
|
2 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
4 months · Low food security
|
1 Participants
|
3 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
4 months · Very low food security
|
0 Participants
|
4 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
12 months · High food security
|
8 Participants
|
5 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
12 months · Marginal food security
|
2 Participants
|
3 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
12 months · Low food security
|
0 Participants
|
2 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
12 months · Very low food security
|
0 Participants
|
3 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
Baseline · High food security
|
9 Participants
|
11 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
Baseline · Marginal food security
|
5 Participants
|
4 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
Baseline · Low food security
|
1 Participants
|
5 Participants
|
|
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module
Baseline · Very low food security
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline, 4 months and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Standard DPP
n=14 Participants
Standard DPP (over 12 months)
DPP: Standard DPP
|
DPP Cooks
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Cooking Attitudes
change from baseline to 12 months
|
3.92 units on a scale
Standard Error 1.89
|
2.07 units on a scale
Standard Error 1.77
|
|
Change From Baseline in Cooking Attitudes
change from baseline to 4 months
|
1.57 units on a scale
Standard Error 1.85
|
-0.28 units on a scale
Standard Error 1.76
|
SECONDARY outcome
Timeframe: baseline, 4 months and 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Standard DPP
n=14 Participants
Standard DPP (over 12 months)
DPP: Standard DPP
|
DPP Cooks
n=15 Participants
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
|
|---|---|---|
|
Change From Baseline in Cooking Behavior (Days Cooking Dinner)
change from baseline to 4 months
|
0.80 days
Standard Error 0.39
|
0.43 days
Standard Error 0.38
|
|
Change From Baseline in Cooking Behavior (Days Cooking Dinner)
change from baseline to 12 months
|
0.86 days
Standard Error 0.41
|
0.49 days
Standard Error 0.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsDPP coaches will report weekly session attendance for all trial participants. Attendance at a higher number of sessions will be a favorable result.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsInvestigators will use interviews or focus groups with DPP Cooks participants to gather qualitative feedback about program satisfaction among participants
Outcome measures
Outcome data not reported
Adverse Events
Standard DPP
DPP Cooks
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Julia Wolfson
Johns Hopkins Bloomberg School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place