NCT05328193

Brief Summary

A randomized controlled trial enrolling 123 parent-infant dyads (English or Spanish speaking) comparing a virtual video Teaching Kitchen Outreach Program (TKO) with weekly grocery delivery (comparator group), to Healthier Families, COVID Edition (intervention group) which includes TKO plus a 12-week virtual health coaching intervention aimed at supporting family goal setting and behavior change including topics such as nutrition and physical activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

March 30, 2022

Last Update Submit

April 7, 2022

Conditions

Behavior, HealthObesity, Childhood

Outcome Measures

Primary Outcomes (1)

  • Family Healthy Lifestyle Subscale

    The 6-item Family Healthy Lifestyle Subscale is a validated measure with higher scores indicating better family health (Crandall A, Weiss-Laxer NS, Broadbent E, et al. The Family Health Scale: Reliability and Validity of a Short- and Long-Form. Front Public Health. 2020;8:587125. doi:10.3389/fpubh.2020.587125). The total score ranges from 6-30 and is calculated by summing the responses to all 6 items of the Family Healthy Lifestyle Subscale. Each item uses a 5-point Likert scale ranging from 1 = "Strongly disagree" to 5 = "Strongly agree."

    Baseline to 12 weeks

Secondary Outcomes (1)

  • Family Resilience and Connection Index

    Baseline to 12 weeks

Other Outcomes (3)

  • Parent Nutrition Scale

    Baseline to 12 weeks

  • Child Nutrition Food Categories

    Baseline to 12 weeks

  • USDA Household Food Security Scale

    Baseline to 12 weeks

Study Arms (2)

Teaching Kitchen Outreach

ACTIVE COMPARATOR

All participants (both the intervention and control condition) will receive to 11 weekly short (about 2-3 minutes) Teaching Kitchen Outreach (TKO) videos. Recipe specific groceries will be delivered to participants' homes by a third party grocery delivery company, or will be available for pickup at a central location(s). These recipes reflect foods that can be purchased with SNAP and WIC and include tested meals and snacks that were developed and evaluated in person in Parks and Recreation after-school programming.

Behavioral: Teaching Kitchen Outreach

Healthier Families, COVID Edition

EXPERIMENTAL

Those randomized to the intervention condition will also receive a 12-weekly health coach via a virtual platform (such as Zoom, FaceTime, or What's App) to provide an adapted version of the previously tested Healthier Families program. Adaptations include: shortening each session to 30 minutes and delivering the programming via a virtual platform. The health coach will provide the Healthier Families modules either to individual child-parent pairs.

Behavioral: Healthier Families, COVID EditionBehavioral: Teaching Kitchen Outreach

Interventions

Healthier Families, COVID EditionBEHAVIORAL

Families randomized to this arm with receive12-weekly health coaching calls virtually with their family with topics such as nutrition, physical activity, sleep, and media use.

Healthier Families, COVID Edition
Teaching Kitchen OutreachBEHAVIORAL

Families receiving this intervention will recipe 11-weekly video recipes and groceries delivered to their door.

Healthier Families, COVID EditionTeaching Kitchen Outreach

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Currently participating in programming with one of the involved community partners, including, Parks and Recreation, Nashville Public Library, Project Transformation, Head Start, Martha O'Bryan, and St. Luke's; Patients who receive primary care at the Vanderbilt Primary Care Pediatrics Clinic are eligible as well.
  • Parent/legal guardian age ≥ 18 years
  • Parent legal guardian of a child ages 2-8
  • Ability to participate on a virtual platform (such as Zoom, FaceTime, What's App, Google Hangouts)
  • Ability to addend a Zoom tool training and complete a baseline survey prior to programming
  • Be able to access virtual programming through online platforms, including YouTube
  • Speak English or Spanish

You may not qualify if:

  • Inability to complete data collection measures via telephone, Redcap, or paper measures
  • Language other than English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

  • Popescu F, Sommer EC, Mahoney MR, Adams LE, Barkin SL. Effect of a Virtual Home-Based Behavioral Intervention on Family Health and Resilience During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2247691. doi: 10.1001/jamanetworkopen.2022.47691.

    PMID: 36538328DERIVED

MeSH Terms

Conditions

Health BehaviorPediatric Obesity

Condition Hierarchy (Ancestors)

BehaviorObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shari Barkin, MD, MSHS

    Vanderbilt Univeristy Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All study personnel that are in a position to change the study protocol or its implementation in study participants should be blinded to information that may allow them to do so, from when the study starts until the study ends, with specific exceptions. This means that all investigators and study staff should be blinded to study data aggregated by study arm that have the potential to impact the study's outcome.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Chief of Academic General Pediatrics

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 14, 2022

Study Start

February 26, 2021

Primary Completion

November 11, 2021

Study Completion

November 11, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)