Brancati Center
Baltimore, Maryland, 21205, United States
NCT Number: NCT05166512
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21205, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6 'food agency' based cooking skills classes during the first 4 months of the DPP
Standard DPP
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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 scores indicating better Food Agency.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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
Investigators will use interviews or focus groups with DPP Cooks participants to gather qualitative feedback about program satisfaction among participants
Johns Hopkins Bloomberg School of Public Health
Other
Development and Pilot Evaluation of a Novel Cooking Skills Intervention to Prevent Diabetes
Acronym: DPPCooks
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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