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

7 aprile 2022 aggiornato da: Shari Barkin, MD, MSHS, Vanderbilt University Medical Center
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.

Panoramica dello studio

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

123

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37212
        • Vanderbilt University Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 2 anni a 8 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Families receiving this intervention will recipe 11-weekly video recipes and groceries delivered to their door.
Sperimentale: 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.
Families receiving this intervention will recipe 11-weekly video recipes and groceries delivered to their door.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Family Healthy Lifestyle Subscale
Lasso di tempo: Baseline to 12 weeks
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Family Resilience and Connection Index
Lasso di tempo: Baseline to 12 weeks
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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Parent Nutrition Scale
Lasso di tempo: Baseline to 12 weeks
Parent nutrition was measured using the Starting the Conversation: Dietary Scale (Paxton AE, Strycker LA, Toobert DJ, Ammerman AS, Glasgow RE. Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals. Am J Prev Med. 2011;40(1):67-71). It is a validated, 8-item instrument to assess diet, with lower scores indicating better nutrition. The total score ranges from 0-16.
Baseline to 12 weeks
Child Nutrition Food Categories
Lasso di tempo: Baseline to 12 weeks
Child nutrition was assessed based on participating children's 30-day consumption of six food categories from the CDC Dietary Screener, which contains items used widely on the Behavioral Risk Factor Surveillance System. Frequency of consumption within the following six food categories was analyzed: sugary beverages (combined soda and sweetened drinks), snacks, sweets, fruits, leafy greens, and other vegetables. The minimum score for each of the six defined food category was 0. There was no maximum score limit.
Baseline to 12 weeks
USDA Household Food Security Scale
Lasso di tempo: Baseline to 12 weeks
Food security was measured using a short form of the USDA Household Food Security Scale, which is a validated, 6-item instrument that categorizes households as food secure or food insecure (Blumberg SJ, Bialostosky K, Hamilton WL, Briefel RR. The effectiveness of a short form of the Household Food Security Scale. Am J Public Health. 1999;89(8):1231-4.). The total USDA Household Food Security score is calculated by summing the number of affirmative responses to each item. The total score ranges from 0-6. A total score less than 2 indicated no food insecurity or hunger. A total score of ≥ 2 indicated food insecurity. A total score of ≥ 5 indicated hunger.
Baseline to 12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Shari Barkin, MD, MSHS, Vanderbilt Univeristy Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 febbraio 2021

Completamento primario (Effettivo)

11 novembre 2021

Completamento dello studio (Effettivo)

11 novembre 2021

Date di iscrizione allo studio

Primo inviato

30 marzo 2022

Primo inviato che soddisfa i criteri di controllo qualità

7 aprile 2022

Primo Inserito (Effettivo)

14 aprile 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 aprile 2022

Ultimo verificato

1 aprile 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 200257

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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