Clinical trial NCT05328193: Food for Thought: Virtual Home-Based Family Interventions to Improve Nutrition Behaviors
Official title: Food for Thought: Virtual Home-Based Family Interventions to Improve Nutrition Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Health
Obesity, Childhood
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Joe C Davis Foundation
First posted: 2022-04-14
Enrollment: 123
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Family Healthy Lifestyle Subscale
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Family Resilience and Connection Index
timeFrame: Baseline to 12 weeks
Other outcomes:
measure: Parent Nutrition Scale
timeFrame: Baseline to 12 weeks
measure: Child Nutrition Food Categories
timeFrame: Baseline to 12 weeks
measure: USDA Household Food Security Scale
timeFrame: Baseline to 12 weeks
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Univeristy Medical Center
name: Shari Barkin, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References: