NCT05166512: DPPCooks

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

Completed NA Results posted Last updated 22 November 2024

What this trial tests

NA trial testing DPP Cooks in Pre-diabetes in 45 participants. Completed in 4 October 2023.

Timeline

2 February 2022

Primary endpoint
4 October 2023

4 October 2023

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	45
Start date	2 February 2022
Primary completion	4 October 2023
Estimated completion	4 October 2023
Sites	1 location across United States

Drugs / interventions tested

• DPP Cooks
• DPP — full drug profile →

Conditions studied

• Pre-diabetes — all drugs for Pre-diabetes →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

18 and older, any sex, with Pre-diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Absolute Body Weight (Kilograms (kg)) Primary · baseline, 4 months and 12 months

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

Group	Value	95% CI
Standard DPP	-2.12	± 1.61
DPP Cooks	-1.00	± 1.55

change from baseline to 12 months

Group	Value	95% CI
Standard DPP	-5.27	± 1.67
DPP Cooks	-4.15	± 1.57

Change From Baseline in Percentage of Baseline Bodyweight Primary · baseline, 4 months and 12 months

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

Group	Value	95% CI
Standard DPP	-1.96	± 1.49
DPP Cooks	-0.95	± 1.44

change from baseline to 12 months

Group	Value	95% CI
Standard DPP	-5.12	± 1.55
DPP Cooks	-4.11	± 1.46

Difference From Baseline in Diet Quality (Healthy Eating Index- 2015) Score Secondary · Baseline and at 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.

Group	Value	95% CI
Standard DPP	1.52	± 3.50
DPP Cooks	-2.81	± 3.37

Change From Baseline in Cooking Confidence Secondary · baseline, 4 months and 12 months

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

Group	Value	95% CI
Standard DPP	0.84	± 1.37
DPP Cooks	0.47	± 1.31

change from baseline to 12 months

Group	Value	95% CI
Standard DPP	1.84	± 1.44
DPP Cooks	1.46	± 1.33

Change From Baseline in Food Agency Measured Via the Cooking and Food Provisioning Action Scale (CAFPAS) Secondary · baseline, 4 months and 12 months

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

change from baseline to 4 months

Group	Value	95% CI
Standard DPP	0.16	± 0.42
DPP Cooks	-0.53	± 0.41

change from baseline to 12 months

Group	Value	95% CI
Standard DPP	0.93	± 0.44
DPP Cooks	0.24	± 0.41

Participant Food Security Status Over the Past 30 Days Using the 10-item United States Department of Agriculture (USDA) Adult Food Security Survey Module Secondary · baseline, 4 months and 12 months

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

Group	Value	95% CI
Standard DPP	9
DPP Cooks	11
Standard DPP	5
DPP Cooks	4
Standard DPP	1
DPP Cooks	5
Standard DPP	1
DPP Cooks	0

4 months

Group	Value	95% CI
Standard DPP	10
DPP Cooks	6
Standard DPP	3
DPP Cooks	2
Standard DPP	1
DPP Cooks	3
Standard DPP	0
DPP Cooks	4

12 months

Group	Value	95% CI
Standard DPP	8
DPP Cooks	5
Standard DPP	2
DPP Cooks	3
Standard DPP	0
DPP Cooks	2
Standard DPP	0
DPP Cooks	3

Change From Baseline in Cooking Attitudes Secondary · baseline, 4 months and 12 months

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

Group	Value	95% CI
Standard DPP	1.57	± 1.85
DPP Cooks	-0.28	± 1.76

change from baseline to 12 months

Group	Value	95% CI
Standard DPP	3.92	± 1.89
DPP Cooks	2.07	± 1.77

Change From Baseline in Cooking Behavior (Days Cooking Dinner) Secondary · baseline, 4 months and 12 months

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

Group	Value	95% CI
Standard DPP	0.80	± 0.39
DPP Cooks	0.43	± 0.38

change from baseline to 12 months

Group	Value	95% CI
Standard DPP	0.86	± 0.41
DPP Cooks	0.49	± 0.38

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.