Metabolic Syndrome, Protection AgainstNCT06099288
Strong Families Start at Home/Familias Fuertes Comienzan en Casa
A study testing Home-Based Video and Motivational Interviewing Intervention and Read Educate and Develop Youth (READY) Comparison in people with Metabolic Syndrome, Protection Against and Diet, Healthy, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Protection Against, Diet, Healthy
- What is being tested?
- Home-Based Video and Motivational Interviewing Intervention and Read Educate and Develop Youth (READY) Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Not have participated in the R34 study
- Have a smart phone
- Be willing to have a meal video recorded in the home
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kelly Bouchard, MPH contact
United States1 site, 1 recruiting
- Recruiting
Brown University
Providence, Rhode Island, 02912
Alison Tovar, 6175990751, alison_tovar@brown.edu
alison_tovar@brown.edu
About this study
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
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?
Read more
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.
Read the 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
- Being tested
- Home-Based Video and Motivational Interviewing Intervention, Read Educate and Develop Youth (READY) Comparison
- Keywords
- Motivational Interview, Home-Based, Intervention, Latinx, Families, Nutrition, Cultural Tailoring, Social Cognitive Theory, Self-Determination Theory, Self-Perception Theory
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Video and Motivational Interviewing InterventionBehavioural
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.
Read Educate and Develop Youth (READY) ComparisonBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Video and Motivational Interviewing Intervention | Experimental | 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. Receives: Behavioral: Home-Based Video and Motivational Interviewing Intervention |
| Read Educate and Develop Youth (READY) Comparison | Active comparator | 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. Receives: Behavioral: Read Educate and Develop Youth (READY) Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up
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.
Measured: Baseline, 6-Month Follow-up
Secondary outcomes (2)
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.
Measured: Baseline, 6-Month Follow-up
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.
Measured: Baseline, 6-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Jan 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome, Protection AgainstStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 257 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Alison Tovar, PhD MPH, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099288
- Sponsor's protocol ID
- 2022003389
- Other IDs
- R01HD108832
- Status last verified
- Aug 2026
- First submitted
- 3 Oct 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tovar A, Bouchard KL, Moore AM, Perry M, Lurssen I, Arriola Carnicelli L, Sanchez Contreras A, Risica P, von Ash T, Savage JS, Dunsiger S, Gans K. Strong Families Start at Home/Familias Fuertes Comienzan en Casa-Improving Child Diet Quality and Parental Feeding Practices: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 10;14:e73923. doi: 10.2196/73923.
PubMed 40929716
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06099288
- Acronym / sponsor ID
- 2022003389
- Keywords
- Motivational Interview, Home-Based, Intervention, Latinx, Families, Nutrition, Cultural Tailoring, Social Cognitive Theory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 257 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Home-Based Video and Motivational Interviewing Intervention | Experimental | Behavioral: Home-Based Video and Motivational Interviewing InterventionThe 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. |
| Read Educate and Develop Youth (READY) Comparison | Active comparator | Behavioral: Read Educate and Develop Youth (READY) ComparisonAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-Based Video and Motivational Interviewing InterventionThe 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. | Behavioural | Home-Based Video and Motivational Interviewing Intervention |
| Read Educate and Develop Youth (READY) ComparisonThe 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. | Behavioural | Read Educate and Develop Youth (READY) Comparison |
Primary outcome
Child Diet Quality
Time frame: 2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up
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
Time frame: Baseline, 6-Month Follow-up
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.
2 secondary outcomes
Food Parenting Practices
Time frame: Baseline, 6-Month Follow-up
Availability of Healthy Foods in the Home
Time frame: Baseline, 6-Month Follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 40929716Tovar A, Bouchard KL, Moore AM, Perry M, Lurssen I, Arriola Carnicelli L, Sanchez Contreras A, Risica P, von Ash T, Savage JS, Dunsiger S, Gans K. Strong Families Start at Home/Familias Fuertes Comienzan en Casa-Improving Child Diet Quality and Parental Feeding Practices: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 10;14:e73923. doi: 10.2196/73923.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Bouchard, MPH contact
Alison Tovar, PhD MPH principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-Based Video and Motivational Interviewing Intervention and Read Educate and Develop Youth (READY) Comparison in people with Metabolic Syndrome, Protection Against and Diet, Healthy, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison Tovar, PhD MPH (401-863-7327, alison_tovar@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Diet Quality (time frame: 2-24-Hour Recalls at Baseline and 2-24-Hour Recalls at 6-Month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06099288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.