SPICE UP MyPlate - Strategy for Promoting Intake of Delicious Healthful Dietary Patterns Based on MyPlate: A Pilot Study

Not Applicable

Recruiting

• Conditions: Cardiometabolic Risk Factors

• Registration Number: NCT06890728
• Lead Sponsor: Penn State University

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.

Study Timeline

• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Study First Posted: 2025-03-24
• Study Start: 2025-04-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-12-23
• Study Completion: 2025-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diet quality change	15 weeks	Change in diet quality assessed by the Healthy Eating Index-2015 (HEI-2015) assessed by 24-hour recalls

Secondary Outcome Measures

Name	Time	Method
Diet quality component scores change	15 weeks	Change in the 13 components that comprise the Healthy Eating Index-2015 (HEI-2015) assessed by 24 hour recalls
Food group intake change	15 weeks	Changes in intake of fruits; vegetables; refined grains; wholegrains; dairy; meat, poultry, eggs; seafood; nuts, seeds and soy products; oils) assessed by 24-hour recalls
Change in intake of added sugars, sodium and saturated fat	15 weeks	Changes in intake of added sugars, sodium and saturated fat assessed by 24 hour recalls
Change in weight	15 weeks	assessed by electronic scale
Change in waist circumference	15 weeks	Assessed by tape measure at 1 cm above the naval
Change in central systolic and diastolic blood pressure	15 weeks	Assessed using a SphymoCor Xcel (Atcor Medical)
Change in brachial systolic and diastolic blood pressure	15 weeks	Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
Change in carotid-femoral pulse wave velocity	15 weeks	Assessed using a SphymoCor Xcel (Atcor Medical)
Change in LDL-cholesterol	15 weeks	Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay.
Change in total cholesterol	15 weeks	Assessed from fasting blood draw expressed in mg/dL.
Change in HDL-Cholesterol	15 weeks	Assessed from fasting blood draw expressed in mg/dL.
Change in triglycerides	15 weeks	Assessed from fasting blood draw expressed in mg/dL.
Change in fasting glucose	15 weeks	Assessed in a fasting blood draw and expressed in mg/dL
Change in HbA1c	15 weeks	Assessed in a fasting blood draw and expressed in %
Program acceptability and satisfaction	15 weeks	Assessed via surveys

Trial Locations

Locations (1)

Pennsylvania State University; 🇺🇸 University Park, Pennsylvania, United States