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

Study Overview
=================
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).

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

Conditions
-----------------
Behavior, Health, Obesity, Childhood

Intervention / Treatment
-----------------
* Behavioral: Healthier Families, COVID Edition
* Behavioral: Teaching Kitchen Outreach


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Teaching Kitchen Outreach<br>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<br>* Families receiving this intervention will recipe 11-weekly video recipes and groceries delivered to their door.<br>|
| Experimental: Healthier Families, COVID Edition<br>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 Edition<br>* 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.<br>Behavioral: Teaching Kitchen Outreach<br>* Families receiving this intervention will recipe 11-weekly video recipes and groceries delivered to their door.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family Resilience and Connection Index | The 6-item Family Resilience and Connection Index is a validated measure with higher scores indicating better family resilience and connection (Bethell CD, Gombojav N, Whitaker RC. Family Resilience And Connection Promote Flourishing Among US Children, Even Amid Adversity. Health Affairs (Millwood). 2019;38(5):729-737). doi:10.1377/hlthaff.2018.05425). The total Family Resilience and Connection Index score is calculated by summing the sub scores of 3 categories (score range in parentheses): Family resilience index (0-4), parent-child connection (0-1), and parent coping (0-1). For the family resilience index, 1 point was assigned for each time a parent responded all of the time to one of the 4 items. 1 point was assigned for each time a parent responded very well to the 2 items on parent-child connection and parent coping. The total score of the FRCI ranges from 0-6. | Baseline to 12 weeks |