NCT06721468

Brief Summary

Regular fish consumption may support brain health. Trout lines developed in Idaho contain higher levels of omega-3 fatty acids, nutrients important for human cognition and mental wellbeing. Developed to support aquaculture sustainability, consumer preferences and human health benefits of these fish are unknown. The long-term goal of this project is to utilize nutrition education strategies to increase adult and child consumption of fish to improve brain health as measured by cognitive and emotional wellbeing. Research objectives and activities include, (1) adult and child consumer panels to provide sensory evaluation on three strains of trout, (2) effects of repeated exposure (RE) and child-centered nutrition phrases (CCNP) on eating behaviors and brain health will be determined using one control and two treatment groups of children in childcare settings, (3) effects of nutrition education, incorporating CCNP and fish preparation techniques, and RE targeting family meals on eating behaviors of children and brain health of adults and children will be determined using four treatment groups in the home setting.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
May 2024Dec 2027

Study Start

First participant enrolled

May 13, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

3.6 years

First QC Date

December 3, 2024

Last Update Submit

December 3, 2024

Conditions

Keywords

TroutChildrenChild-Centered Nutrition PhrasesCognitionEmotional well-beingSensory evaluation

Outcome Measures

Primary Outcomes (5)

  • Change in liking from baseline to 12-weeks

    subjects rate their liking of trout on a 3-point scale (yummy, just okay, yucky)

    Change from baseline liking at 12-weeks

  • Change in intake from baseline to 12-weeks

    Subjects are offered 2oz of trout each week for 12 weeks. Trout servings are weighed pre/post consumption as a proxy of intake.

    Change from baseline intake at 12-weeks

  • Change in cognition composite score from baseline to 12-weeks

    Subjects complete a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Early childhood cognition composite score is derived from scores on tthe Dimensional Change Card Sort, Flanker, Picture Sequence Memory, Picture Vocabulary, and Speeded Matching tests.

    Change from baseline cognition composite score at 12-weeks

  • Change in emotion score from baseline to 12-weeks

    Subjects complete a battery of computerized self-reported or parent proxy questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function.

    Change from baseline emotion score at 12-weeks

  • Difference in liking among three trout strains

    subjects rate their liking of three different trout strains

    measured 1 time upon enrollment

Secondary Outcomes (1)

  • Change in fluid cognition composite score from baseline to 12-weeks

    Change from baseline cognition composite score at 12-weeks

Study Arms (8)

Objective 1: Sensory Evaluation

EXPERIMENTAL

three different strains of trout (fish-meal diet, CX line, CLX line)

Other: Trout

Objective 2: Repeated Exposure

EXPERIMENTAL

2 oz of trout each week for 10 weeks

Other: Trout

Objective 2: Repeated Exposure Plus Child-Centered Nutrition Phrases

EXPERIMENTAL

2 oz of trout each week plus exposure to positive nutrition message about trout each week for 10 weeks

Other: TroutOther: Child-centered nutrition phrases

Objective 2: Puzzle Game

PLACEBO COMPARATOR

Exposure to a puzzle game each week for 10 weeks

Other: Puzzle

Objective 3: Eat Smart Idaho

NO INTERVENTION

Only receive Eat Smart Idaho's standard 6-lesson in-person series of classes

Objective 3: Child-Centered Nutrition Phrases

EXPERIMENTAL

Receive Eat Smart Idaho's standard 6-lesson in-person series of classes AND asked to view an online trout-specific nutrition education and recipe preparation video series, "About Trout! Pond to Plate."

Other: Child-centered nutrition phrases

Objective 3: Repeated Exposure

EXPERIMENTAL

Receive Eat Smart Idaho's standard 6-lesson in-person series of classes AND receive 2 servings of trout per week for 12 weeks, to prepare at home and consume (2 oz. serving for child and 4 oz. serving for adult).

Other: Trout

Objective 3: Repeated Exposure Plus Child Centered Nutrition Phrases

EXPERIMENTAL

Receive Eat Smart Idaho's standard 6-lesson in-person series of classes, AND receive 2 servings of trout per week for 12 weeks, to prepare at home and consume (2 oz. serving for child and 4 oz. serving for adult), AND asked to view an online trout-specific nutrition education and recipe preparation video series, "About Trout! Pond to Plate."

Other: TroutOther: Child-centered nutrition phrases

Interventions

TroutOTHER

rainbow trout

Objective 1: Sensory EvaluationObjective 2: Repeated ExposureObjective 2: Repeated Exposure Plus Child-Centered Nutrition PhrasesObjective 3: Repeated ExposureObjective 3: Repeated Exposure Plus Child Centered Nutrition Phrases

learn the phrase, "trout helps your brain so you can learn and play" either through researcher introduction or completing the "About Trout! Pond to Plate" curriculum

Objective 2: Repeated Exposure Plus Child-Centered Nutrition PhrasesObjective 3: Child-Centered Nutrition PhrasesObjective 3: Repeated Exposure Plus Child Centered Nutrition Phrases
PuzzleOTHER

presented with a puzzle to solve each week

Objective 2: Puzzle Game

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Objective 1: Children 3-6 years of age, adults age 18+, English speaking
  • Objective 2: Children 4-6 years of age, English speaking
  • Objective 3: Children 4-9 years of age AND parent/guardian, English or Spanish speaking, access to internet, currently eat fish less than twice per week

You may not qualify if:

  • allergy or dietary restriction preventing consuming fish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Idaho

Moscow, Idaho, 83843, United States

RECRUITING

Washington State University

Pullman, Washington, 99164, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Annie J Roe, PhD

    University of Idaho

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie J Roe, PhD

CONTACT

Matt Powell, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Objective 1: Two untrained consumer panels will provide sensory evaluation on three different strains of trout (fish-meal diet, CX line, CLX line). Objective 2: A within subjects, pre/post design will be employed to compare the effect of repeated exposure (RE) and repeated exposure plus child centered nutrition phrases (RE+CCNP) on eating behaviors of children 4-6 years of age. Objective 3: A 12-week quasi-experimental design will be employed to capture the translational impact of repeated exposure and nutrition education to the home setting on intake of whole CX line trout and the effect on adult and youth cognitive and emotional wellbeing outcomes. A control and three treatment groups will be recruited from a convenience sample of Eat Smart Idaho participants in northern and south central Idaho.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

May 13, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Persons requesting the data will be required to obtain and share IRB approval and to sign a data sharing agreement. Data will be made available one year after the primary manuscripts detailing the major outcomes of the study are published.

Locations