Clinical trial NCT06890728: SPICE UP MyPlate - Strategy for Promoting Intake of Delicious Healthful Dietary Patterns Based on MyPlate: A Pilot Study
Official title: SPICE UP MyPlate - Strategy for Promoting Intake of Delicious Healthful Dietary Patterns Based on MyPlate: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiometabolic Risk Factors
Keywords: diet quality
nutrition education
culinary medicine
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 50
Sex: ALL
Minimum age (years): 31
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim is to conduct a pilot study to assess the feasibility, acceptability and potential effectiveness of culinary focused nutrition education to promote increased adherence to the Dietary Guidelines for Americans compared to standard low-intensity care.

Detailed description: This is a 15-week, 2-arm randomized controlled pilot trial. In a 1:1 ratio, participants will be randomized to the intervention arm or the control arm. The intervention group will receive a 12-week culinary focused nutrition education program. The control group will receive standard low-intensity care (i.e., printed healthy eating material). Outcome measures will be assessed at baseline and 15 weeks.

Eligibility criteria: Inclusion Criteria:

* Age 31-59 years
* Involved in meal cooking at home and consumes a home cooked meal ≥ 1 time per week
* Individuals taking medications for blood pressure, lipid or glucose lowering will be eligible if they have been on a stable dose for the 1 month prior to baseline

Exclusion Criteria:

* A member of the household is already enrolled (only one person per household will be eligible for inclusion in the study).
* Unstable medical conditions requiring active intervention (surgeries, medication/drug therapy for \< 3 months) as assessed during the telephone screening (e.g. cancer, kidney disease requiring dialysis, heart or gastrointestinal diseases requiring surgery).
* Received nutrition education for a medical condition within the past 6 months
* Currently following a weight loss diet
* Lost ≥ 10% body weight in the past 6 months
* Currently (within 6 months) smoke or use any tobacco or nicotine containing products
* Currently pregnant or given birth within the prior 6 months
* Currently participating in another clinical trial
* Principal investigator discretion (e.g., disrespectful or inappropriate interactions with study staff)
* Does not speak or understand English

Primary outcomes:
measure: Diet quality change
timeFrame: 15 weeks
Secondary outcomes:
measure: Diet quality component scores change
timeFrame: 15 weeks
measure: Food group intake change
timeFrame: 15 weeks
measure: Change in intake of added sugars, sodium and saturated fat
timeFrame: 15 weeks
measure: Change in weight
timeFrame: 15 weeks
measure: Change in waist circumference
timeFrame: 15 weeks
measure: Change in central systolic and diastolic blood pressure
timeFrame: 15 weeks
measure: Change in brachial systolic and diastolic blood pressure
timeFrame: 15 weeks
measure: Change in carotid-femoral pulse wave velocity
timeFrame: 15 weeks
measure: Change in LDL-cholesterol
timeFrame: 15 weeks
measure: Change in total cholesterol
timeFrame: 15 weeks
measure: Change in HDL-Cholesterol
timeFrame: 15 weeks
measure: Change in triglycerides
timeFrame: 15 weeks
measure: Change in fasting glucose
timeFrame: 15 weeks
measure: Change in HbA1c
timeFrame: 15 weeks
measure: Program acceptability and satisfaction
timeFrame: 15 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Kristina Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: