NCT05863559

Brief Summary

Given the limited effectiveness of single food group-targeted interventions to enhance child nutrition, a key component of current and future health, innovative approaches are needed. Healthy dietary patterns are emerging as an important intervention target, and the Mediterranean Dietary pattern has been particularly effective at reducing cardiovascular disease risk factors, a leading cause of death in the US. Since parents are the gatekeepers of the home food environment and influence child intake through food-related parenting practices, children enjoy cooking with parents, and home food preparation is associated with more healthful dietary intake. Therefore, the investigators propose to develop and assess the feasibility, acceptability, and preliminary efficacy of an online cooking intervention for parent-child dyads living in low-income households that promotes the Mediterranean dietary pattern and healthful food-related parenting practices.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress92%
Sep 2022Sep 2026

Study Start

First participant enrolled

September 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

3.9 years

First QC Date

April 11, 2023

Last Update Submit

July 17, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Recruitment goal attainment as assessed by staff logs

    Staff will maintain logs of the number of families who express interest in the study and of those, the number who qualify and enroll in the study

    pre-intervention

  • Number of families who complete all phases of the study as assessed by staff logs

    Staff will maintain logs of when a family completes each phase of the study, including pre-intervention data collection, the online program sessions, and data collection immediately after completing the intervention. Family completion is defined as both parent and child completion of a phase.

    through study completion, an average of 10 weeks

  • Parent satisfaction with the Intervention as assessed by a 10 item survey

    The 10-item measure has been used by Dr. Thompson in previous studies with children and adults. Items will be rated using a 2-point Likert scale (no=1, yes=2). Scores can range from 10-20, with higher scores representing higher satisfaction

    immediately after the intervention

  • Child satisfaction with the Intervention as assessed by a 10 item survey

    The 10-item measure has been used by Dr. Thompson in previous studies with children and adults. Items will be rated using a 2-point Likert scale (no=1, yes=2). Scores can range from 10-20, with higher scores representing higher satisfaction

    immediately after the intervention

  • Acceptability of wearing recording device at pre-intervention as assessed by agreement to wear a recording device

    Staff will maintain logs of parents who agree to wear the recording device as part of pre-intervention data collection (yes=1, no=0).

    pre-intervention

  • Acceptability of recording device immediately after the intervention as assessed by agreement to wear the device

    Staff will maintain logs of parents who agree to wear a recording device as part of data collection immediately after the intervention (yes=1, no=0).

    immediately after the intervention

  • Usability of recordings from device collected during pre-intervention data collection as assessed by staff logs

    Staff will maintain logs of number of recordings generated and the number of recordings that could be analyzed

    pre-intervention

  • Usability of recordings from device collected during data collection immediately after the intervention as assessed by staff logs

    Staff will maintain logs of number of recordings generated and the number of recordings that could be analyzed

    immediately after the intervention

Secondary Outcomes (11)

  • Change in autonomous motivation to help child learn to cook as assessed by the adapted Treatment Self-Regulation Motivation Questionnaire

    immediately after the intervention

  • Change in parent self efficacy to involve child in home food preparation as assessed by the adapted self-efficacy scale of the Cooking and Food Provisioning Action Scale

    pre-intervention, immediately after the intervention

  • Change in parent self efficacy to use food parenting practices as assessed by the Competence/Self-Efficacy for Vegetable Food Parenting Practices Scale

    pre-intervention, immediately after the intervention

  • Change in home food availability as assessed by parent completion of the Fulkerson et al Home Food Inventory

    pre-intervention, immediately after the intervention

  • Change in child involvement in home food preparation as assessed by parent response to the question used in the Eating and Activity over Time project (Project EAT)

    pre-intervention, immediately after the intervention

  • +6 more secondary outcomes

Other Outcomes (9)

  • Change in child height in inches as assessed by remotely observed parent assessment

    pre-intervention, immediately after the intervention

  • Change in parent height in inches as assessed by remotely observed self-assessment

    pre-intervention, immediately after the intervention

  • Change in child weight in pounds as assessed by remotely observed parent measurement

    pre-intervention, immediately after the intervention

  • +6 more other outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

After completing baseline data collection, families randomized to the intervention group will receive the 4-session prototype over a period of up to 6 weeks. This will allow for illness, family vacations, school holidays, and scheduling conflicts. After completing session 4, the family will proceed to post assessment. The investigators have successfully used this approach in previous interventions. It is anticipated each session will take \~1.5 hrs to complete (online phase - \~30 minutes; home phase - \~1 hr). The parent and child will each be assigned a password with which to login to the online phase. Parents and children will be asked to keep their password private. Each will need to login at the same time to view each new online session. The session can be viewed by parent or child separately or together after the initial viewing.

Behavioral: Super Chef: Family Fun in the Kitchen!

Wait-list control

NO INTERVENTION

Families randomized to this group will receive the intervention after the dyad completes both baseline and post intervention data collection.

Interventions

Two-phase intervention: in the online phase, a professional chef will demonstrate cooking strategies to help families modify existing recipes to be consistent with the Mediterranean Dietary pattern. Effective food parenting practices will also be integrated into the intervention. The intervention is guided by theory - Family Systems, Social Cognitive, and Self Determination - and gamification techniques. At the end of the online phase, dyads will set a goal to use the cooking strategy and make a plan to facilitate goal attainment. In the home phase, the dyad will work together to use the plan to meet the goal. Dyads can also participate in bonus activities. Prior to viewing the next session, dyads will report whether the goal was attained and any bonus activities completed. Collectively, this will determine level of Super Chef status the family achieves at the end of the program (Session 4).

Treatment

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a 10-12 years old child and a parent/caregiver
  • family qualifies for free or reduced price meals at school
  • reliable internet access
  • resident of Texas
  • fluent in English

You may not qualify if:

  • major auditory or vision impairment
  • lack of binocular vision
  • history of seizure disorder
  • claustrophobia
  • vertigo
  • psychiatric conditions (e.g., paranoia, manic depressive psychosis)
  • prior dizziness or motion sickness when using virtual reality
  • currently being treated with medications or medical condition that impacts dietary intake (e.g., cancer, attention deficit hyperactivity disorder) or ability to participate in data collection (e.g., intellectual impairments)
  • physician advice to modify diet for a current or ongoing health or medical condition
  • eligible but child birth sex stratum (male, female) filled
  • another parent or sibling participated in program development

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Study Officials

  • Deborah Thompson, PhD

    USDA/ARS CNRC, BAYLOR COLLEGE OF MEDICINE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Two group randomized controlled trial - treatment, waitlist control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

April 11, 2023

First Posted

May 18, 2023

Study Start

September 30, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations