Childhood ObesityNCT02669797
Family Matters Intervention
A study testing In-home Visits and Food Preparation Activities, Ecological Momentary Intervention and Feedback on Video-recorded Family Meals in people with Childhood Obesity and Cardiovascular Disease Prevention, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The proposed study is a 12-month, individual randomized controlled trial (RCT). The main aim of the study is to decrease cardiovascular disease risk (BMI percentile, neck circumference) and improve child diet quality in children ages 5-10 years old by increasing family meal quality (i.e., dietary intake, interpersonal… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Cardiovascular Disease Prevention
- What is being tested?
- In-home Visits and Food Preparation Activities, Ecological Momentary Intervention and Feedback on Video-recorded Family Meals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2022to Apr 2028
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
STUDY INCLUSION CRITERIA
The inclusionary criteria used to select participants for the proposed study includes:
- Boys and girls (n=500) ages 5-10 years old who attend a primary care clinic (e.g., pediatrics, family medicine) in Minneapolis or St. Paul metro area, Minnesota or Denver metro area, Colorado and their primary caregiver (e.g., mother, father, grandparent) and any other family members (e.g., sibling, cousin).
- Must eat ≤3 family dinner meals per week. Research shows that youth who have more than three family meals per week are less likely to be obese/high risk for cardiovascular disease ten years later. Thus, families who report three or fewer family meals per week will be recruited to optimize the potential for change in family meal frequency. Families will focus on the family dinner in the intervention to improve their family meal quality and quantity. This decision is based on: (1) Family Systems Theory, which indicates that change in one setting (e.g., family dinner) will generalize to other settings (e.g., breakfast, lunch, snacks).
- Child with age and sex adjusted BMI ≥75th percentile (no upper limit).
- One of the following race/ethnicities: African American, Asian, Hispanic/Latino, Native American, Asian American, or White. In order to examine racial/ethnic differences in study hypotheses, equal numbers of children per racial/ethnic group (total=500) will be recruited.
- Parent and family members who speak English or Spanish.
- Not expected to move within the next two years.
STUDY EXCLUSION CRITERIA
The exclusionary criteria used to exclude participants from the proposed study includes:
- Children with medically necessary dietary restrictions.
- Non-custodial parents, who the child does not live with more than 50% of the time.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Colorado Anschutz Medical Campus--ACCORDS
Aurora, Colorado, 80045
University of Minnesota--Department of Family Social Science
Minneapolis, Minnesota, 55414
About this study
Official title: Reducing Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback at Family Meals
The proposed study is a 12-month, individual randomized controlled trial (RCT). The main aim of the study is to decrease cardiovascular disease risk (BMI percentile, neck circumference) and improve child diet quality in children ages 5-10 years old by increasing family meal quality (i.e., dietary intake, interpersonal atmosphere) and quantity (i.e., frequency of family meals) via innovative technology (i.e., ecological momentary intervention (EMI), video feedback) and partnerships with primary care and Community Health Workers (CHWs).
Read the detailed description
The RCT has the following three arms: (1) Ecological Momentary Intervention (EMI); (2) EMI + HV + Video feedback (virtual); (3) EMI + HV + Video feedback (hybrid). Delivery of the intervention will last 6 months for each family, with a 6-month post-intervention evaluation visit. All arms will receive EMI family meal tips via smartphones for 16 weeks. Arms 2 and 3 will also receive 16 weeks of in-home training (arm 2 will be virtual, arm 3 will be hybrid virtual/in-home), with 8 weeks (every other week) in-home education visits with a CHW focused on family meal quality and quantity and family meal preparation activities and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW. Additionally, Arms 2 and 3 will receive video feedback from family's video-recorded family meals by a CHW focusing on family behaviors related to family meal quality and quantity. (EMI, in-home training, and video-feedback will occur during the same 16-week period.) After families have completed 16 weeks of the intervention, a 8-week maintenance phase will ensue. Having a maintenance phase is an evidence-based intervention component and will provide incrementally less support to families to build self-efficacy and increase sustainability of new behaviors. Over time, participants will receive less study support to evaluate if participants have internalized healthful behaviors. During the maintenance phase EMI meal tips will be reduced to only the days in which parents report their highest stress levels for all arms. The study will last 12 months, with three assessment time points including, baseline, 6 months (i.e., post-intervention) and 12 months.
Children ages 5-10 and family members (i.e., parent/primary caregiver, siblings) from low-income and diverse households (i.e., African American, Asian, Hispanic, Native American, White) - who are at high risk for cardiovascular disease - will be recruited for the study. Theory informs the intervention study design, research questions and related hypotheses, methods, measurement, and analysis. Family Systems Theory drives the decision to direct the intervention at the "family unit" to increase the likelihood of individual and family-level weight and weight-related behavior change and sustainability. Additionally, partnerships with existing community-based healthcare systems and CHWs will be utilized to reach participants in community settings.
This study utilizes innovative and research-informed intervention components (i.e., in-home visiting, EMI, video-feedback) to increase the likelihood of intervention effectiveness and sustainability.
Specific Aims of the Intervention Include:
- Aim 1 (Primary Outcomes): Conduct a three-arm RCT comparing EMI, EMI+HV, and EMI+HV+Video Feedback in diverse children ages 5-10 and their families to test the hypotheses that:
Hypothesis 1: BMI percentile and neck circumference will decrease and diet quality will increase in children in the EMI+HV+Video Feedback hybrid arm compared to children in the EMI or virtual-only arms.
- Aim 2 (Secondary Outcomes): Examine intervention effects on familial, parental, and sibling factors.
Hypothesis 1: Family meal quality and quantity will increase in households with children in the EMI+HV+ Video Feedback hybrid arm compared to children in the EMI or virtual arms.
Hypothesis 2: Controlling feeding practices (e.g., restriction) will decrease and coping skills will increase in parents in the EMI+HV+Video Feedback hybrid arm compared to parents in the EMI or virtual arms.
Hypothesis 3: BMI percentile will decrease in siblings in the EMI+HV+Video Feedback hybrid arm compared to siblings in the EMI or virtual arms.
- Aim 3: Examine cost effectiveness and feasibility of intervention implementation in primary care.
Hypothesis 1: The BMI z-score and neck circumference reduction resulting from the intervention will be cost-effective.
- Being tested
- In-home Visits and Food Preparation Activities, Ecological Momentary Intervention, Feedback on Video-recorded Family Meals, Maintenance
- Keywords
- Childhood Obesity, Ecological Momentary Intervention, Video Feedback, Cardiovascular Disease, Cardiovascular Health, Community Health Worker, Home Visiting, Virtual, Hybrid
- Medical subject headings
- Pediatric Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home Visits and Food Preparation ActivitiesBehavioural
Families will participate in eight in-home education activities. The visits will focus on family meal quality (dietary, interpersonal) and quantity (meal frequency) factors found in prior studies to be associated with child weight and weight-related behaviors. Eight of the visits (every other week) will be delivered by a CHW and will last 90 minutes. Additionally, a family meal food preparation activity will occur to help support families in learning skills to increase family meal quality and quantity. On weeks opposite of the in-home education visits with a CHW, families will be given a "Try it Yourself" activity to reinforce the messages (e.g., use family meals as a family connection time) and skills (e.g., recipe that requires families to steam vegetables) taught by the CHW during the in-home education visits.
Ecological Momentary InterventionBehavioural
Parents will receive daily EMI messages regarding suggestions for increasing meal quality/quantity via a smartphone application, based on the stress level and source of stress they reported earlier in the day. Specifically, parents will receive two push notifications in the morning to report their stress level and type/source of stress (e.g., work, children, finances). Then, based on the reported stress level and source of stress, parents will be texted tips/ideas for carrying out a nutritionally and emotionally healthful family meal the same night, in the face of stress. If parents report no stress on their EMI measure earlier in the day, they will be provided with a menu of options regarding what type of meal tip they would prefer later in the day (e.g., recipe ideas, meal prep tips, mealtime conversation starters. Parents will be able to respond to the EMI messages indicating preferred tips so that EMI tips become more meaningful/relevant to the needs of each family.
Feedback on Video-recorded Family MealsBehavioural
Parents will video-record and upload via their cellphone one family meal every other week, which will be watched by intervention staff. Using Motivational Interviewing, CHWs will give specific feedback on how to adapt negative mealtime behaviors and provide reinforcement for positive behaviors seen in the videos, based on a validated interpersonal coding tool called the Iowa Family Interaction Rating Scales (IFIRS). Additionally, feedback will be given on the dietary healthfulness of the meal, based on a validated coding tool called the Healthfulness of Meal Index (HOM). After feedback, family members will be taught specific skills to improve their family meal processes and behaviors that vary from food preparation skills, to increasing healthful food options at meals, or role-playing family interactions to improve the emotional atmosphere at the meal. Families will also set SMART goals at each visit regarding family meal quality and quantity.
MaintenanceBehavioural
After 16 weeks, EMI family meal tips for all arms will be reduced to only the days in which parent's report their highest stress levels. Stress profiles will be created for each parent in order to tailor the EMI family meals tips to days in which they experience their highest levels of stress. For example, during the 16-weeks of EMI, a parent may report their highest stress levels on Tuesdays and Thursdays. The stress profile that would be created for the parent during the maintenance phase would include receiving text messages only on Tuesdays and Thursdays. The parent would then receive these EMI family meal tips only on Tuesdays and Thursdays throughout the 8-week maintenance phase..
| Study group | Role | What they receive |
|---|---|---|
| EMI | Experimental | EMI (Arm 1): (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; and (2) a 8-week maintenance phase with EMI tips delivered on high stress days. Receives: Behavioral: Ecological Momentary Intervention; Behavioral: Maintenance |
| EMI + HV + Video feedback, Virtual | Experimental | EMI + HV + Video Feedback (Arm 2) education visits will all be delivered virtually, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals) and meal preparation activities, and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days. Receives: Behavioral: In-home Visits and Food Preparation Activities; Behavioral: Ecological Momentary Intervention; Behavioral: Maintenance |
| EMI + HV + Video feedback, Hybrid | Experimental | EMI + HV + Video Feedback (Arm 3) education visits will be delivered virtually and in-home, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals) and meal preparation demonstrations, and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days. Receives: Behavioral: In-home Visits and Food Preparation Activities; Behavioral: Ecological Momentary Intervention; Behavioral: Feedback on Video-recorded Family Meals; Behavioral: Maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child BMI percentile
Based on Centers for Disease Control and Prevention (CDC) guidelines, child age and sex will be used to calculate an adjusted BMI percentiles. Measured at three time points over 12 months by study staff.
Measured: 12-months post-baseline
Child Dietary Quality
Child three-day, 24-hour dietary recalls will be used to calculate a Healthy Eating Index (HEI) score, which measures overall dietary quality.
Measured: 12-months post-baseline
Child Neck Circumference
Measured neck circumference on child
Measured: 12-months post-baseline
Secondary outcomes (6)
Family Meal Quantity
Family meal frequency as measured by a self-report survey item at three time points over 12 months.
Measured: 12-months post-baseline
Family Meal Dietary Healthfulness
Family meal dietary quality as measured by the Healthfulness of Meal (HOM) index via video-recorded direct observation at three time points over 12 months.
Measured: 12-months post-baseline
Family Meal Emotional Atmosphere Quality
Family meal emotional atmosphere quality as measured by the Iowa Family Interaction Rating Scales (IFIRS) via video-recorded direct observation and EMA surveys at three time points over 12 months.
Measured: 12-months post-baseline
Sibling BMI percentile
Based on Centers for Disease Control and Prevention (CDC) guidelines, sibling age and sex will be used to calculate an adjusted BMI percentiles. Measured at four time points over 12 months by study staff.
Measured: 12-months post-baseline
Parent Feeding Practices
Parent feeding practices (e.g., restriction, pressure-to-eat) will be measured at three time points over a 12-month period using validated measures in EMA surveys.
Measured: 12-months post-baseline
Parent Coping Skills
Parent coping (i.e., ability to manage stress) will be measured at three time over a 12-month period using validated measures in EMA surveys.
Measured: 12-months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start11 Feb 2022
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, individual randomized controlled trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669797
- Sponsor's protocol ID
- FMCH-2017-25964
- Other IDs
- R33HL151978
- Status last verified
- Sep 2025
- First submitted
- 18 Jan 2016
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the proposed study will be shared through the NHLBI data repository. As required by NHLBI, the data set will be submitted to the study NHLBI study Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Following the NHLBI policy for data sharing from clinical trials and epidemiological studies and the guidelines for NHLBI data set preparation, we will submit our data set including the following measures: baseline, interim visit, ancillary data, procedural based data, and outcome data, along with laboratory measurements not otherwise summarized. Data will be formatted using standard statistical software and modifications and redactions will follow NHLBI guidelines.
Publications
Berge JM, Trofholz AC, Aqeel M, Norderud K, Tate A, Fertig AR, Loth K, Mendenhall T, Neumark-Sztainer D. A three-arm randomized controlled trial using ecological momentary intervention, community health workers, and video feedback at family meals to improve child cardiovascular health: the Family Matters study design. BMC Public Health. 2023 Apr 19;23(1):708. doi: 10.1186/s12889-023-15504-2.
PubMed 37072737Berge JM, Trofholz AC, Aqeel M, Norderud K, Tate A, Fertig AR, Loth K, Mendenhall T, Neumark-Sztainer D. A Three-Arm Randomized Controlled Trial Using Ecological Momentary Intervention, Community Health Workers, and Video Feedback at Family Meals to Improve Child Cardiovascular Health: The Family Matters Study Design. Res Sq [Preprint]. 2023 Mar 22:rs.3.rs-2662682. doi: 10.21203/rs.3.rs-2662682/v1.
PubMed 36993265
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback at Family Meals
- ClinicalTrials.gov ID
- NCT02669797
- Acronym / sponsor ID
- FMCH-2017-25964
- Keywords
- Childhood Obesity, Ecological Momentary Intervention, Video Feedback, Cardiovascular Disease, Cardiovascular Health, Community Health Worker, Home Visiting, Virtual
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), University of Minnesota
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 1 Feb 2016 (estimated)
- 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 proposed study is a 12-month, individual randomized controlled trial (RCT). The main aim of the study is to decrease cardiovascular disease risk (BMI percentile, neck circumference) and improve child diet quality in children ages 5-10 years old by increasing family meal quality (i.e., dietary intake, interpersonal atmosphere) and quantity (i.e., frequency of family meals) via innovative technology (i.e., ecological momentary intervention (EMI), video feedback) and partnerships with primary care and Community Health Workers (CHWs).
Detailed description
The RCT has the following three arms: (1) Ecological Momentary Intervention (EMI); (2) EMI + HV + Video feedback (virtual); (3) EMI + HV + Video feedback (hybrid). Delivery of the intervention will last 6 months for each family, with a 6-month post-intervention evaluation visit. All arms will receive EMI family meal tips via smartphones for 16 weeks. Arms 2 and 3 will also receive 16 weeks of in-home training (arm 2 will be virtual, arm 3 will be hybrid virtual/in-home), with 8 weeks (every other week) in-home education visits with a CHW focused on family meal quality and quantity and family meal preparation activities and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW. Additionally, Arms 2 and 3 will receive video feedback from family's video-recorded family meals by a CHW focusing on family behaviors related to family meal quality and quantity. (EMI, in-home training, and video-feedback will occur during the same 16-week period.) After families have completed 16 weeks of the intervention, a 8-week maintenance phase will ensue. Having a maintenance phase is an evidence-based intervention component and will provide incrementally less support to families to build self-efficacy and increase sustainability of new behaviors. Over time, participants will receive less study support to evaluate if participants have internalized healthful behaviors. During the maintenance phase EMI meal tips will be reduced to only the days in which parents report their highest stress levels for all arms. The study will last 12 months, with three assessment time points including, baseline, 6 months (i.e., post-intervention) and 12 months.
Children ages 5-10 and family members (i.e., parent/primary caregiver, siblings) from low-income and diverse households (i.e., African American, Asian, Hispanic, Native American, White) - who are at high risk for cardiovascular disease - will be recruited for the study. Theory informs the intervention study design, research questions and related hypotheses, methods, measurement, and analysis. Family Systems Theory drives the decision to direct the intervention at the "family unit" to increase the likelihood of individual and family-level weight and weight-related behavior change and sustainability. Additionally, partnerships with existing community-based healthcare systems and CHWs will be utilized to reach participants in community settings.
This study utilizes innovative and research-informed intervention components (i.e., in-home visiting, EMI, video-feedback) to increase the likelihood of intervention effectiveness and sustainability.
Specific Aims of the Intervention Include:
- Aim 1 (Primary Outcomes): Conduct a three-arm RCT comparing EMI, EMI+HV, and EMI+HV+Video Feedback in diverse children ages 5-10 and their families to test the hypotheses that:
Hypothesis 1: BMI percentile and neck circumference will decrease and diet quality will increase in children in the EMI+HV+Video Feedback hybrid arm compared to children in the EMI or virtual-only arms.
- Aim 2 (Secondary Outcomes): Examine intervention effects on familial, parental, and sibling factors.
Hypothesis 1: Family meal quality and quantity will increase in households with children in the EMI+HV+ Video Feedback hybrid arm compared to children in the EMI or virtual arms.
Hypothesis 2: Controlling feeding practices (e.g., restriction) will decrease and coping skills will increase in parents in the EMI+HV+Video Feedback hybrid arm compared to parents in the EMI or virtual arms.
Hypothesis 3: BMI percentile will decrease in siblings in the EMI+HV+Video Feedback hybrid arm compared to siblings in the EMI or virtual arms.
- Aim 3: Examine cost effectiveness and feasibility of intervention implementation in primary care.
Hypothesis 1: The BMI z-score and neck circumference reduction resulting from the intervention will be cost-effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, individual randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| EMI | Experimental | Behavioral: Ecological Momentary Intervention, Behavioral: MaintenanceEMI (Arm 1): (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; and (2) a 8-week maintenance phase with EMI tips delivered on high stress days. |
| EMI + HV + Video feedback, Virtual | Experimental | Behavioral: In-home Visits and Food Preparation Activities, Behavioral: Ecological Momentary Intervention, Behavioral: MaintenanceEMI + HV + Video Feedback (Arm 2) education visits will all be delivered virtually, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals) and meal preparation activities, and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days. |
| EMI + HV + Video feedback, Hybrid | Experimental | Behavioral: In-home Visits and Food Preparation Activities, Behavioral: Ecological Momentary Intervention, Behavioral: Feedback on Video-recorded Family Meals, Behavioral: MaintenanceEMI + HV + Video Feedback (Arm 3) education visits will be delivered virtually and in-home, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals) and meal preparation demonstrations, and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| In-home Visits and Food Preparation ActivitiesFamilies will participate in eight in-home education activities. The visits will focus on family meal quality (dietary, interpersonal) and quantity (meal frequency) factors found in prior studies to be associated with child weight and weight-related behaviors. Eight of the visits (every other week) will be delivered by a CHW and will last 90 minutes. Additionally, a family meal food preparation activity will occur to help support families in learning skills to increase family meal quality and quantity. On weeks opposite of the in-home education visits with a CHW, families will be given a "Try it Yourself" activity to reinforce the messages (e.g., use family meals as a family connection time) and skills (e.g., recipe that requires families to steam vegetables) taught by the CHW during the in-home education visits. | Behavioural | EMI + HV + Video feedback, Hybrid, EMI + HV + Video feedback, Virtual |
| Ecological Momentary InterventionParents will receive daily EMI messages regarding suggestions for increasing meal quality/quantity via a smartphone application, based on the stress level and source of stress they reported earlier in the day. Specifically, parents will receive two push notifications in the morning to report their stress level and type/source of stress (e.g., work, children, finances). Then, based on the reported stress level and source of stress, parents will be texted tips/ideas for carrying out a nutritionally and emotionally healthful family meal the same night, in the face of stress. If parents report no stress on their EMI measure earlier in the day, they will be provided with a menu of options regarding what type of meal tip they would prefer later in the day (e.g., recipe ideas, meal prep tips, mealtime conversation starters. Parents will be able to respond to the EMI messages indicating preferred tips so that EMI tips become more meaningful/relevant to the needs of each family. | Behavioural | EMI, EMI + HV + Video feedback, Hybrid, EMI + HV + Video feedback, Virtual |
| Feedback on Video-recorded Family MealsParents will video-record and upload via their cellphone one family meal every other week, which will be watched by intervention staff. Using Motivational Interviewing, CHWs will give specific feedback on how to adapt negative mealtime behaviors and provide reinforcement for positive behaviors seen in the videos, based on a validated interpersonal coding tool called the Iowa Family Interaction Rating Scales (IFIRS). Additionally, feedback will be given on the dietary healthfulness of the meal, based on a validated coding tool called the Healthfulness of Meal Index (HOM). After feedback, family members will be taught specific skills to improve their family meal processes and behaviors that vary from food preparation skills, to increasing healthful food options at meals, or role-playing family interactions to improve the emotional atmosphere at the meal. Families will also set SMART goals at each visit regarding family meal quality and quantity. | Behavioural | EMI + HV + Video feedback, Hybrid |
| MaintenanceAfter 16 weeks, EMI family meal tips for all arms will be reduced to only the days in which parent's report their highest stress levels. Stress profiles will be created for each parent in order to tailor the EMI family meals tips to days in which they experience their highest levels of stress. For example, during the 16-weeks of EMI, a parent may report their highest stress levels on Tuesdays and Thursdays. The stress profile that would be created for the parent during the maintenance phase would include receiving text messages only on Tuesdays and Thursdays. The parent would then receive these EMI family meal tips only on Tuesdays and Thursdays throughout the 8-week maintenance phase.. | Behavioural | EMI, EMI + HV + Video feedback, Hybrid, EMI + HV + Video feedback, Virtual |
Primary outcome
Child BMI percentile
Time frame: 12-months post-baseline
Based on Centers for Disease Control and Prevention (CDC) guidelines, child age and sex will be used to calculate an adjusted BMI percentiles. Measured at three time points over 12 months by study staff.
Child Dietary Quality
Time frame: 12-months post-baseline
Child three-day, 24-hour dietary recalls will be used to calculate a Healthy Eating Index (HEI) score, which measures overall dietary quality.
Child Neck Circumference
Time frame: 12-months post-baseline
Measured neck circumference on child
6 secondary outcomes
Family Meal Quantity
Time frame: 12-months post-baseline
Family Meal Dietary Healthfulness
Time frame: 12-months post-baseline
Family Meal Emotional Atmosphere Quality
Time frame: 12-months post-baseline
Sibling BMI percentile
Time frame: 12-months post-baseline
Parent Feeding Practices
Time frame: 12-months post-baseline
Parent Coping Skills
Time frame: 12-months post-baseline
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 22 Sep 2025.
- Background: PubMed 37072737Berge JM, Trofholz AC, Aqeel M, Norderud K, Tate A, Fertig AR, Loth K, Mendenhall T, Neumark-Sztainer D. A three-arm randomized controlled trial using ecological momentary intervention, community health workers, and video feedback at family meals to improve child cardiovascular health: the Family Matters study design. BMC Public Health. 2023 Apr 19;23(1):708. doi: 10.1186/s12889-023-15504-2.
- Derived from this study: PubMed 36993265Berge JM, Trofholz AC, Aqeel M, Norderud K, Tate A, Fertig AR, Loth K, Mendenhall T, Neumark-Sztainer D. A Three-Arm Randomized Controlled Trial Using Ecological Momentary Intervention, Community Health Workers, and Video Feedback at Family Meals to Improve Child Cardiovascular Health: The Family Matters Study Design. Res Sq [Preprint]. 2023 Mar 22:rs.3.rs-2662682. doi: 10.21203/rs.3.rs-2662682/v1.
- Individual participant dataSharing planned: Yes. Data from the proposed study will be shared through the NHLBI data repository. As required by NHLBI, the data set will be submitted to the study NHLBI study Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Following the NHLBI policy for data sharing from clinical trials and epidemiological studies and the guidelines for NHLBI data set preparation, we will submit our data set including the following measures: baseline, interim visit, ancillary data, procedural based data, and outcome data, along with laboratory measurements not otherwise summarized. Data will be formatted using standard statistical software and modifications and redactions will follow NHLBI guidelines.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-home Visits and Food Preparation Activities, Ecological Momentary Intervention and Feedback on Video-recorded Family Meals in people with Childhood Obesity and Cardiovascular Disease Prevention, run by University of Colorado, Denver at 2 sites 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?
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: enrolling by invitation, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child BMI percentile (time frame: 12-months post-baseline). The study lists 3 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 NCT02669797, which also lists 2 linked publications.
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 22 Sep 2025.