NCT06890728

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

March 17, 2025

Last Update Submit

February 9, 2026

Conditions

Keywords

diet qualitynutrition educationculinary medicine

Outcome Measures

Primary Outcomes (1)

  • Diet quality change

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

    15 weeks

Secondary Outcomes (15)

  • Diet quality component scores change

    15 weeks

  • Food group intake change

    15 weeks

  • Change in intake of added sugars, sodium and saturated fat

    15 weeks

  • Change in weight

    15 weeks

  • Change in waist circumference

    15 weeks

  • +10 more secondary outcomes

Study Arms (2)

Culinary focused nutrition education

EXPERIMENTAL

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.

Behavioral: Culinary focused nutrition education

Standard nutrition education

ACTIVE COMPARATOR

The control group will represent standard low intensity nutrition education. Control group participants will be provided with a printed MyPlate resource.

Behavioral: Standard low intensity nutrition education

Interventions

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

Culinary focused nutrition education

Provided by a written MyPlate resource

Standard nutrition education

Eligibility Criteria

Age31 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Study Officials

  • Kristina Petersen, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 24, 2025

Study Start

April 28, 2025

Primary Completion

December 12, 2025

Study Completion

December 12, 2025

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
SAP
Time Frame
Statistical analysis plan will be uploaded before database lock and unblinding of randomization codes

Locations