Food for Thought: Virtual Home-Based Family Interventions to Improve Nutrition Behaviors

NCT ID: NCT05328193

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-26

Study Completion Date

2021-11-11

Brief Summary

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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.

Detailed Description

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The aim of this work is to conduct a randomized controlled trial to test the effect of two evidenced based programs (Healthier Families and Teaching Kitchen Outreach (TKO) adapted to a virtual platform on improving family health.

Both the intervention and comparator condition receive up to 12 weekly short (about 2-3 minutes) Teaching Kitchen Outreach (TKO) videos. Recipe specific groceries are delivered to participants' homes by a third party grocery delivery company, and are 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 (Heerman W, Elsakary Y, Sommer E, Escarfuller J, Barkin S. Assessing the Scale and Spread of an Experiential Teaching Kitchen in After-School Programming Among School-Aged Children) through the long-standing Nashville Collaborative partnership (https://pediatrics.vumc.org/nashville-collaborative). Over more than a decade, the Nashville Collaborative has developed and tested programs together to improve health and wellness and reduce childhood obesity in the local community.

Those randomized to the intervention condition 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 provides the Healthier Families modules to individual child-parent pairs. Any use of Zoom for participant participation will use a version of Zoom procured through Vanderbilt. The virtual version of Healthier Families was adapted from prior research in the Growing Right Onto Wellness (GROW) trial that worked with over 600 parent-child dyads and demonstrated a statistically significant effect on health behavior change (Barkin SL, Heerman WJ, Sommer EC, Martin NC, Buchowski MS, Schlundt D, Po'e EK, Burgess LE, Escarfuller J, Pratt C, Truesdale KP, Stevens J. Effect of a Behavioral Intervention for Underserved Preschool-Age Children on Change in Body Mass Index: A Randomized Clinical Trial).

Conditions

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Behavior, Health Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Teaching Kitchen Outreach

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.

Group Type ACTIVE_COMPARATOR

Teaching Kitchen Outreach

Intervention Type BEHAVIORAL

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

Healthier Families, COVID Edition

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.

Group Type EXPERIMENTAL

Healthier Families, COVID Edition

Intervention Type BEHAVIORAL

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.

Teaching Kitchen Outreach

Intervention Type BEHAVIORAL

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

Interventions

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Healthier Families, COVID Edition

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.

Intervention Type BEHAVIORAL

Teaching Kitchen Outreach

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Inability to complete data collection measures via telephone, Redcap, or paper measures
* Language other than English or Spanish
Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Joe C Davis Foundation

UNKNOWN

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shari Barkin, MD, MSHS

Division Chief of Academic General Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shari Barkin, MD, MSHS

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Univeristy Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36538328 (View on PubMed)

Other Identifiers

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200257

Identifier Type: -

Identifier Source: org_study_id

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