SPICE UP MyPlate - Strategy for Promoting Intake of Delicious Healthful Dietary Patterns Based on MyPlate: A Pilot Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Kristina Petersen, PhD
- Phone Number: 814-865-7206
- Email: kup63@psu.edu
Study Contact Backup
- Name: Stacey Meily
- Phone Number: 814-863-8622
- Email: sas117@psu.edu
Study Locations
-
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Pennsylvania
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University Park, Pennsylvania, United States, 16802
- Pennsylvania State University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Culinary focused nutrition education
The intervention group will receive a 12-week culinary focused nutrition education program.
Participants in the intervention group will receive culinary focused nutrition education based on MyPlate with an emphasis on taste and enjoyment of healthy foods.
Using herbs and spices to flavor foods will be the emphasis.
The intervention will be delivered in an online format with online content delivery .
The intervention will consist of eight modules.
Modules one to four will be provided during the first month.
Modules four to eight will be provided during months 2 and 3.
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Culinary focused nutrition education based on MyPlate with an emphasis on taste and enjoyment of healthy foods.
|
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Active Comparator: Standard nutrition education
The control group will represent standard low intensity nutrition education.
Control group participants will be provided with a printed MyPlate resource.
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Provided by a written MyPlate resource
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet quality change
Time Frame: 15 weeks
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Change in diet quality assessed by the Healthy Eating Index-2015 (HEI-2015) assessed by 24-hour recalls
|
15 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
15 weeks
|
|
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
|
15 weeks
|
|
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
|
15 weeks
|
|
Change in weight
Time Frame: 15 weeks
|
assessed by electronic scale
|
15 weeks
|
|
Change in waist circumference
Time Frame: 15 weeks
|
Assessed by tape measure at 1 cm above the naval
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15 weeks
|
|
Change in central systolic and diastolic blood pressure
Time Frame: 15 weeks
|
Assessed using a SphymoCor Xcel (Atcor Medical)
|
15 weeks
|
|
Change in brachial systolic and diastolic blood pressure
Time Frame: 15 weeks
|
Blood pressure measured assessed using a SphymoCor Xcel (Atcor Medical)
|
15 weeks
|
|
Change in carotid-femoral pulse wave velocity
Time Frame: 15 weeks
|
Assessed using a SphymoCor Xcel (Atcor Medical)
|
15 weeks
|
|
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.
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15 weeks
|
|
Change in total cholesterol
Time Frame: 15 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
15 weeks
|
|
Change in HDL-Cholesterol
Time Frame: 15 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
15 weeks
|
|
Change in triglycerides
Time Frame: 15 weeks
|
Assessed from fasting blood draw expressed in mg/dL.
|
15 weeks
|
|
Change in fasting glucose
Time Frame: 15 weeks
|
Assessed in a fasting blood draw and expressed in mg/dL
|
15 weeks
|
|
Change in HbA1c
Time Frame: 15 weeks
|
Assessed in a fasting blood draw and expressed in %
|
15 weeks
|
|
Program acceptability and satisfaction
Time Frame: 15 weeks
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Assessed via surveys
|
15 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Kristina Petersen, PhD, Penn State University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- SUP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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