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Strong Families Start at Home/Familias Fuertes Comienzan en Casa

Primary Purpose

Metabolic Syndrome, Protection Against, Diet, Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home-Based Video and Motivational Interviewing Intervention
Read Educate and Develop Youth (READY) Comparison
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome, Protection Against focused on measuring Motivational Interview, Home-Based, Intervention, Latinx, Families, Nutrition, Cultural Tailoring, Social Cognitive Theory, Self-Determination Theory, Self-Perception Theory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: At least 18 years old Self-identity as Latinx/Hispanic Speak English or Spanish Be the primary caregiver of a child between 2- 5 years of age Live with the child most of the time Eat a minimum of three evening meals per week with the child Not have participated in the R34 study Have a smart phone Be willing to have a meal video recorded in the home Exclusion Criteria: A doctor or WIC provider has told them that their child was underweight in the past 6 months The child has a diagnosed feeding disorder or dietary restriction that impacts how they eat

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Home-Based Video and Motivational Interviewing Intervention

    Read Educate and Develop Youth (READY) Comparison

    Arm Description

    The intervention will be delivered in English or Spanish by a trained CHW and consists of three home-based visits with tailored print materials, text-messages delivered 2x/week, followed by monthly tailored print materials and phone calls during the last three months of the intervention. For in-home visits, the CHW will deliver a Motivational Interviewing session based on scripts developed in the R34. For phone calls, parents will receive a 30-minute Motivational Interviewing phone call to check in on goals and barriers and reinforce earlier concepts. For text messages, parents will be sent two times/week messages related to objectives targeted during that month's visit, such as parents setting good examples and giving children autonomy in eating. For print materials, parents will receive printed materials, highlighting nutrition and parental feeding guidance.

    As done in the R34, the comparison group will receive an attention contact control intervention about school readiness promotion adapted from R.E.A.D.Y. (Read Educate and Develop Youth) designed by the Michigan Department of Education (Refs). Families in the comparison arm will receive the same intervention components as the intervention arm, but these will be focused on child reading rather than nutrition. Parents will send a video of themselves reading with a child, receive 3 home visits and 48 text-messages as well as newsletters for each visit. Instead of receiving cooking materials during the second home visit, they will receive books to read with their children.

    Outcomes

    Primary Outcome Measures

    Child Diet Quality
    Caloric and macronutrient intake will be averaged over two dietary recalls. Caloric and macronutrient intake will be averaged over the two recalls. Healthy Eating Index (HEI)-2015 components (total fruit, whole fruit, total vegetable, dark green and orange vegetables and legumes, total grain, whole grain, milk, meat and beans, saturated fat, sodium, added sugars, and solid fats) are assessed per 1000 kcal to provide a density-based score except for saturated fats and added sugars with are % of energy. Component scores are then summed to provide a total HEI score.
    Child's Dermal Carotenoids
    The Veggie Meter device will provide an objective, non-invasive and quick measure reflecting fruit and vegetable intake. This device uses reflection spectroscopy to detect the level of carotenoids in human skin. Three measures (10 seconds each spaced by 30-seconds) will be taken and averaged. Scores range from 0 to 800 with higher scores indicating greater fruit and vegetable intake.

    Secondary Outcome Measures

    Food Parenting Practices
    Food parenting practices will be measured by the Food Parenting Inventory. Investigators will measure pre-post changes to 8 subscales: 1) child involvement in food preparation; 2) responsiveness to child's fullness cues; 3) encourage exploration of new foods; 4) repeated presentation of new foods; 5) regular timing of meals and snacks; 6) encourage try new foods; 7) inconsistent mealtimes; 8) food as a reward; and the Healthy Eating Guidance subscale of the Comprehensive Feeding Practices Questionnaire. All of the items are rated on a 5-point Likert scale ranging from never-always and disagree-agree. Higher subscale scores indicate greater use of that practice.
    Availability of Healthy Foods in the Home
    The Home Food Inventory (HFI) will be used to assess a range of available foods in the home environment. Research staff will inventory the foods in the kitchen. The HFI includes 13 food categories (e.g., cheese, milk/dairy, F&V), whether F&V were fresh, canned/jarred, frozen, or dried, and two categories on food accessibility. HFI items are listed in a checklist format with yes/no options.

    Full Information

    First Posted
    October 3, 2023
    Last Updated
    October 23, 2023
    Sponsor
    Brown University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06099288
    Brief Title
    Strong Families Start at Home/Familias Fuertes Comienzan en Casa
    Official Title
    Strong Families Start at Home/Familias Fuertes Comienzan en Casa: A Novel Video and Motivational Interviewing Intervention to Improve Diet Quality of Low-income, Ethnically Diverse Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    November 1, 2027 (Anticipated)
    Study Completion Date
    November 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Brown University
    Collaborators
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to test the ability of a home-based parental nutrition intervention to improve diet quality in preschool aged children within low-income, Latinx/Hispanic families. The main questions it aims to answer are: Does this enhanced intervention change children's diet quality? Does this enhanced intervention change parental feeding practices? Does this enhanced intervention change the availability of healthy foods in the home? Participants will: Work with a support coach Have a home visit with a support coach once a month, for three months Have a phone call with a support coach once a month, for three months Receive written materials and text messages over the six months Researchers will compare a control group receiving different written materials and messages to see if the enhanced intervention changes diet quality in children.
    Detailed Description
    Investigators will build on the recently completed R34 (R34HL140229) that developed and pilot-tested the feasibility, acceptability, and preliminary efficacy of a novel home-based intervention to improve the diet quality and home food environment of low-income, ethnically diverse preschool children (87% Latinx). Despite the study occurring during COVID-19, the intervention delivery was feasible and acceptable to participants and achieved encouraging improvements in children's diet quality and positive food parenting practices. For the proposed research the investigators will build upon lessons learned in the pilot to evaluate the efficacy of the novel Strong Families intervention to improve food parenting practices, home food environment, parent, and children's diet quality in a fully powered randomized controlled trial (RCT) with 257 families of a 2-5-year-old child. The intervention will include: Home visits by a community health worker (CHW) trained in brief motivational interviewing; screening for social-determinants of health and connecting families to federal/state/local resources; in-home cooking demonstrations to prepare a meal involving their child; feedback about a family meal-time video Text-messages Tailored materials/messages CHW phone calls These strategies are expected to connect families to community systems, increase parental knowledge, self-efficacy, and motivation for serving easy, inexpensive healthy foods leading to increased child exposure to more healthy and varied foods, improvements in parental feeding practices and ultimately, improvements in child diet quality. The RCT will include baseline, 6 & 12-month measurements to test the following aims: Aim 1: Improve the dietary intakes of 2-5-year-old children Aim 2: Improve food parenting practices Aim 3. Improve the availability of healthy foods in the home

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, Protection Against, Diet, Healthy
    Keywords
    Motivational Interview, Home-Based, Intervention, Latinx, Families, Nutrition, Cultural Tailoring, Social Cognitive Theory, Self-Determination Theory, Self-Perception Theory

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    After baseline measures are complete, parent-child dyads will be randomly assigned to either the Intervention (I) or Comparison group (C) using random generator software. Because parents will need to complete a second recall over the phone after completing in-person measurements, randomization will happen over the phone. The project manager will let parents know by phone what group they are in and conduct an orientation about upcoming activities for each group.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Intervention staff (Project coordinator & Community Health Workers) will know what group each participant has been allocated to. Evaluation teams will be masked. Additionally, participants will know if they have been assigned to the group focused on "child feeding" or the group focused on "child reading readiness", but will not be told that one is the intervention group and one is the comparison group.
    Allocation
    Randomized
    Enrollment
    257 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Home-Based Video and Motivational Interviewing Intervention
    Arm Type
    Experimental
    Arm Description
    The intervention will be delivered in English or Spanish by a trained CHW and consists of three home-based visits with tailored print materials, text-messages delivered 2x/week, followed by monthly tailored print materials and phone calls during the last three months of the intervention. For in-home visits, the CHW will deliver a Motivational Interviewing session based on scripts developed in the R34. For phone calls, parents will receive a 30-minute Motivational Interviewing phone call to check in on goals and barriers and reinforce earlier concepts. For text messages, parents will be sent two times/week messages related to objectives targeted during that month's visit, such as parents setting good examples and giving children autonomy in eating. For print materials, parents will receive printed materials, highlighting nutrition and parental feeding guidance.
    Arm Title
    Read Educate and Develop Youth (READY) Comparison
    Arm Type
    Active Comparator
    Arm Description
    As done in the R34, the comparison group will receive an attention contact control intervention about school readiness promotion adapted from R.E.A.D.Y. (Read Educate and Develop Youth) designed by the Michigan Department of Education (Refs). Families in the comparison arm will receive the same intervention components as the intervention arm, but these will be focused on child reading rather than nutrition. Parents will send a video of themselves reading with a child, receive 3 home visits and 48 text-messages as well as newsletters for each visit. Instead of receiving cooking materials during the second home visit, they will receive books to read with their children.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Home-Based Video and Motivational Interviewing Intervention
    Intervention Description
    The intervention consists of three home-based visits, followed by phone calls during the last three months of the intervention. For each visit and phone call, participants will receive tailored print materials, and during the 6 months of the interventions, they will receive text messages 2x/week. The intervention will be delivered in English or Spanish by a bilingual Community Health Worker (CHW). The CHW will be hired to serve as MI counselors for the parents in the study, and will be in charge of delivering the MI in-home or telephone sessions. CHWs will be trained for 3 months, in Motivational Interviewing, study protocols, the use of video recordings, meal preparation, and cooking, and will undergo a MI certification process. During the sessions with the participants, the CHW will deliver semi-scripted MI sessions based on the scripts developed in the pilot study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Read Educate and Develop Youth (READY) Comparison
    Intervention Description
    The comparison group will receive an attention contact control intervention about school readiness promotion adapted from R.E.A.D.Y. (Read Educate and Develop Youth) designed by the Michigan Department of Education. The intervention consists of three home-based visits, followed by phone calls during the last three months of the intervention. For each visit and phone call, participants will receive tailored print materials, and during the 6 months of the interventions, they will receive text messages 2x/week. The intervention will be delivered in English or Spanish by a bilingual Community Health Worker (CHW). Families will receive the same intervention components as the intervention, but about reading instead of nutrition.
    Primary Outcome Measure Information:
    Title
    Child Diet Quality
    Description
    Caloric and macronutrient intake will be averaged over two dietary recalls. Caloric and macronutrient intake will be averaged over the two recalls. Healthy Eating Index (HEI)-2015 components (total fruit, whole fruit, total vegetable, dark green and orange vegetables and legumes, total grain, whole grain, milk, meat and beans, saturated fat, sodium, added sugars, and solid fats) are assessed per 1000 kcal to provide a density-based score except for saturated fats and added sugars with are % of energy. Component scores are then summed to provide a total HEI score.
    Time Frame
    2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up
    Title
    Child's Dermal Carotenoids
    Description
    The Veggie Meter device will provide an objective, non-invasive and quick measure reflecting fruit and vegetable intake. This device uses reflection spectroscopy to detect the level of carotenoids in human skin. Three measures (10 seconds each spaced by 30-seconds) will be taken and averaged. Scores range from 0 to 800 with higher scores indicating greater fruit and vegetable intake.
    Time Frame
    Baseline, 6-Month Follow-up
    Secondary Outcome Measure Information:
    Title
    Food Parenting Practices
    Description
    Food parenting practices will be measured by the Food Parenting Inventory. Investigators will measure pre-post changes to 8 subscales: 1) child involvement in food preparation; 2) responsiveness to child's fullness cues; 3) encourage exploration of new foods; 4) repeated presentation of new foods; 5) regular timing of meals and snacks; 6) encourage try new foods; 7) inconsistent mealtimes; 8) food as a reward; and the Healthy Eating Guidance subscale of the Comprehensive Feeding Practices Questionnaire. All of the items are rated on a 5-point Likert scale ranging from never-always and disagree-agree. Higher subscale scores indicate greater use of that practice.
    Time Frame
    Baseline, 6-Month Follow-up
    Title
    Availability of Healthy Foods in the Home
    Description
    The Home Food Inventory (HFI) will be used to assess a range of available foods in the home environment. Research staff will inventory the foods in the kitchen. The HFI includes 13 food categories (e.g., cheese, milk/dairy, F&V), whether F&V were fresh, canned/jarred, frozen, or dried, and two categories on food accessibility. HFI items are listed in a checklist format with yes/no options.
    Time Frame
    Baseline, 6-Month Follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At least 18 years old Self-identity as Latinx/Hispanic Speak English or Spanish Be the primary caregiver of a child between 2- 5 years of age Live with the child most of the time Eat a minimum of three evening meals per week with the child Not have participated in the R34 study Have a smart phone Be willing to have a meal video recorded in the home Exclusion Criteria: A doctor or WIC provider has told them that their child was underweight in the past 6 months The child has a diagnosed feeding disorder or dietary restriction that impacts how they eat
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alison Tovar, PhD MPH
    Phone
    401-863-7327
    Email
    alison_tovar@brown.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kelly Bouchard, MPH
    Email
    kelly_bouchard@brown.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alison Tovar, PhD MPH
    Organizational Affiliation
    Brown University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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