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OpenTrials
Completed

NCT Number: NCT06890728

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

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.

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Key information

Age range

31 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culinary focused nutrition education

Behavioral

Culinary focused nutrition education based on MyPlate with an emphasis on taste and enjoyment of healthy foods.

Standard low intensity nutrition education

Behavioral

Provided by a written MyPlate resource

Primary outcomes

  1. Diet quality change

    Time frame: 15 weeks

    Change in diet quality assessed by the Healthy Eating Index-2015 (HEI-2015) assessed by 24-hour recalls

Secondary outcomes

  1. Diet quality component scores change

    Time frame: 15 weeks

    Change in the 13 components that comprise the Healthy Eating Index-2015 (HEI-2015) assessed by 24 hour recalls

  2. Food group intake change

    Time frame: 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

  3. Change in intake of added sugars, sodium and saturated fat

    Time frame: 15 weeks

    Changes in intake of added sugars, sodium and saturated fat assessed by 24 hour recalls

  4. Change in weight

    Time frame: 15 weeks

    assessed by electronic scale

  5. Change in waist circumference

    Time frame: 15 weeks

    Assessed by tape measure at 1 cm above the naval

  6. Change in central systolic and diastolic blood pressure

    Time frame: 15 weeks

    Assessed using a SphymoCor Xcel (Atcor Medical)

  7. Change in brachial systolic and diastolic blood pressure

    Time frame: 15 weeks

    Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)

  8. Change in carotid-femoral pulse wave velocity

    Time frame: 15 weeks

    Assessed using a SphymoCor Xcel (Atcor Medical)

  9. Change in LDL-cholesterol

    Time frame: 15 weeks

    Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay.

  10. Change in total cholesterol

    Time frame: 15 weeks

    Assessed from fasting blood draw expressed in mg/dL.

  11. Change in HDL-Cholesterol

    Time frame: 15 weeks

    Assessed from fasting blood draw expressed in mg/dL.

  12. Change in triglycerides

    Time frame: 15 weeks

    Assessed from fasting blood draw expressed in mg/dL.

  13. Change in fasting glucose

    Time frame: 15 weeks

    Assessed in a fasting blood draw and expressed in mg/dL

  14. Change in HbA1c

    Time frame: 15 weeks

    Assessed in a fasting blood draw and expressed in %

  15. Program acceptability and satisfaction

    Time frame: 15 weeks

    Assessed via surveys

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 24, 2025
Registry last updated
Feb 12, 2026

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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