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Pilot Trial of a Novel Cooking Skills Intervention (DPPCooks) to Prevent Diabetes

Development and Pilot Evaluation of a Novel Cooking Skills Intervention to Prevent Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05166512
Acronym
DPPCooks
Enrollment
45
Registered
2021-12-22
Start date
2022-02-02
Completion date
2023-10-04
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-diabetes

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALDPP Cooks

6 'food agency' based cooking skills classes during the first 4 months of the DPP

BEHAVIORALDPP

Standard DPP

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults in Baltimore City * eligible for DPP based on Centers for Disease Control guidelines * possession of a smart phone with camera * can commit to 12 month study participation

Exclusion criteria

* current or prior diagnosis of type 1- or type 2 diabetes * non-English speaker * participating in another research study that may effect diabetes, diet, or weight loss * currently pregnant

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Absolute Body Weight (Kilograms (kg))baseline, 4 months and 12 monthsWeight 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 in Percentage of Baseline Bodyweightbaseline, 4 months and 12 monthsWeight 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).

Secondary

MeasureTime frameDescription
Change From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)baseline, 4 months and 12 monthsThe 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.
Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Modulebaseline, 4 months and 12 monthsThe 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).
Change From Baseline in Cooking Attitudesbaseline, 4 months and 12 monthsCooking 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 in Cooking Behavior (Days Cooking Dinner)baseline, 4 months and 12 monthsCooking 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.
Difference From Baseline in Diet Quality (Healthy Eating Index- 2015) ScoreBaseline and at 4 monthsDietary 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.
Change From Baseline in Cooking Confidencebaseline, 4 months and 12 monthsCooking 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.

Other

MeasureTime frameDescription
Program Attendance Among DPP and DPP Cooks Participants12 monthsDPP coaches will report weekly session attendance for all trial participants. Attendance at a higher number of sessions will be a favorable result.
Program Satisfaction Among DPP Cooks Participants (Qualitative)12 monthsInvestigators will use interviews or focus groups with DPP Cooks participants to gather qualitative feedback about program satisfaction among participants

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard DPP
Standard DPP (over 12 months) DPP: Standard DPP
16
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
20
Total36

Withdrawals & dropouts

PeriodReasonFG000FG001
12 Month Data CollectionLost to Follow-up31
12 Month Data CollectionWithdrawal by Subject10
4 Month Data CollectionLost to Follow-up10
4 Month Data CollectionWithdrawal by Subject15
Baseline Data CollectionLost to Follow-up03
Baseline Data CollectionProtocol Violation20
Baseline Data CollectionWithdrawal by Subject10
RandomizedLost to Follow-up20
RandomizedWithdrawal by Subject10

Baseline characteristics

CharacteristicStandard DPPDPP CooksTotal
Age, Continuous55.1 years
STANDARD_DEVIATION 12.8
56.5 years
STANDARD_DEVIATION 17.2
55.9 years
STANDARD_DEVIATION 15.2
Education
college graduate
6 Participants12 Participants18 Participants
Education
high school
6 Participants2 Participants8 Participants
Education
some college
3 Participants6 Participants9 Participants
Education
some high school
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants20 Participants35 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Income
#35,000-$59,000/ year
6 Participants5 Participants11 Participants
Income
<$35,000/ year
6 Participants7 Participants13 Participants
Income
$60,000-$85,000/ year
1 Participants5 Participants6 Participants
Income
>$85,000/ year
3 Participants3 Participants6 Participants
Marital Status
divorced, separated, widowed
6 Participants6 Participants12 Participants
Marital Status
living with partner
1 Participants3 Participants4 Participants
Marital Status
married
3 Participants7 Participants10 Participants
Marital Status
single
6 Participants4 Participants10 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
12 Participants14 Participants26 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants4 Participants
Race (NIH/OMB)
White
3 Participants3 Participants6 Participants
Region of Enrollment
United States
16 Participants20 Participants36 Participants
Sex: Female, Male
Female
12 Participants17 Participants29 Participants
Sex: Female, Male
Male
4 Participants3 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 23
other
Total, other adverse events
0 / 220 / 23
serious
Total, serious adverse events
0 / 220 / 23

Outcome results

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).

Time frame: baseline, 4 months and 12 months

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Standard DPPChange From Baseline in Absolute Body Weight (Kilograms (kg))change from baseline to 4 months-2.12 kgStandard Error 1.61
Standard DPPChange From Baseline in Absolute Body Weight (Kilograms (kg))change from baseline to 12 months-5.27 kgStandard Error 1.67
DPP CooksChange From Baseline in Absolute Body Weight (Kilograms (kg))change from baseline to 4 months-1.00 kgStandard Error 1.55
DPP CooksChange From Baseline in Absolute Body Weight (Kilograms (kg))change from baseline to 12 months-4.15 kgStandard Error 1.57
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).

Time frame: baseline, 4 months and 12 months

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Standard DPPChange From Baseline in Percentage of Baseline Bodyweightchange from baseline to 4 months-1.96 percentage of body weightStandard Error 1.49
Standard DPPChange From Baseline in Percentage of Baseline Bodyweightchange from baseline to 12 months-5.12 percentage of body weightStandard Error 1.55
DPP CooksChange From Baseline in Percentage of Baseline Bodyweightchange from baseline to 4 months-0.95 percentage of body weightStandard Error 1.44
DPP CooksChange From Baseline in Percentage of Baseline Bodyweightchange from baseline to 12 months-4.11 percentage of body weightStandard Error 1.46
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.

Time frame: baseline, 4 months and 12 months

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Standard DPPChange From Baseline in Cooking Attitudeschange from baseline to 4 months1.57 units on a scaleStandard Error 1.85
Standard DPPChange From Baseline in Cooking Attitudeschange from baseline to 12 months3.92 units on a scaleStandard Error 1.89
DPP CooksChange From Baseline in Cooking Attitudeschange from baseline to 4 months-0.28 units on a scaleStandard Error 1.76
DPP CooksChange From Baseline in Cooking Attitudeschange from baseline to 12 months2.07 units on a scaleStandard Error 1.77
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.

Time frame: baseline, 4 months and 12 months

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Standard DPPChange From Baseline in Cooking Behavior (Days Cooking Dinner)change from baseline to 4 months0.80 daysStandard Error 0.39
Standard DPPChange From Baseline in Cooking Behavior (Days Cooking Dinner)change from baseline to 12 months0.86 daysStandard Error 0.41
DPP CooksChange From Baseline in Cooking Behavior (Days Cooking Dinner)change from baseline to 4 months0.43 daysStandard Error 0.38
DPP CooksChange From Baseline in Cooking Behavior (Days Cooking Dinner)change from baseline to 12 months0.49 daysStandard Error 0.38
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.

Time frame: baseline, 4 months and 12 months

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Standard DPPChange From Baseline in Cooking Confidencechange from baseline to 4 months0.84 units on a scaleStandard Error 1.37
Standard DPPChange From Baseline in Cooking Confidencechange from baseline to 12 months1.84 units on a scaleStandard Error 1.44
DPP CooksChange From Baseline in Cooking Confidencechange from baseline to 4 months0.47 units on a scaleStandard Error 1.31
DPP CooksChange From Baseline in Cooking Confidencechange from baseline to 12 months1.46 units on a scaleStandard Error 1.33
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.

Time frame: baseline, 4 months and 12 months

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Standard DPPChange From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)change from baseline to 4 months0.16 change in score on a scaleStandard Error 0.42
Standard DPPChange From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)change from baseline to 12 months0.93 change in score on a scaleStandard Error 0.44
DPP CooksChange From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)change from baseline to 4 months-0.53 change in score on a scaleStandard Error 0.41
DPP CooksChange From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS)change from baseline to 12 months0.24 change in score on a scaleStandard Error 0.41
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.

Time frame: Baseline and at 4 months

Population: all individuals with data at baseline and 4 months

ArmMeasureValue (MEAN)Dispersion
Standard DPPDifference From Baseline in Diet Quality (Healthy Eating Index- 2015) Score1.52 score on a scaleStandard Error 3.5
DPP CooksDifference From Baseline in Diet Quality (Healthy Eating Index- 2015) Score-2.81 score on a scaleStandard Error 3.37
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).

Time frame: baseline, 4 months and 12 months

Population: Analyzed among all participants enrolled and at each time point. One participant still enrolled at 12 months was missing data for food insecurity.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey ModuleBaselineHigh food security9 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey ModuleBaselineMarginal food security5 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey ModuleBaselineLow food security1 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey ModuleBaselineVery low food security1 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module4 monthsHigh food security10 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module4 monthsMarginal food security3 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module4 monthsLow food security1 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module4 monthsVery low food security0 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module12 monthsHigh food security8 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module12 monthsMarginal food security2 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module12 monthsLow food security0 Participants
Standard DPPParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module12 monthsVery low food security0 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module12 monthsLow food security2 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey ModuleBaselineHigh food security11 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module4 monthsLow food security3 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey ModuleBaselineMarginal food security4 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module12 monthsMarginal food security3 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey ModuleBaselineLow food security5 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module4 monthsVery low food security4 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey ModuleBaselineVery low food security0 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module12 monthsVery low food security3 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module4 monthsHigh food security6 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module12 monthsHigh food security5 Participants
DPP CooksParticipant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module4 monthsMarginal food security2 Participants
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.

Time frame: 12 months

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

Time frame: 12 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026