Family Matters Intervention
Reducing Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback at Family Meals
2 other identifiers
interventional
500
1 country
2
Brief 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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedStudy Start
First participant enrolled
February 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
September 22, 2025
September 1, 2025
5.1 years
January 18, 2016
September 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
12-months post-baseline
Child Neck Circumference
Measured neck circumference on child
12-months post-baseline
Secondary Outcomes (6)
Family Meal Quantity
12-months post-baseline
Family Meal Dietary Healthfulness
12-months post-baseline
Family Meal Emotional Atmosphere Quality
12-months post-baseline
Sibling BMI percentile
12-months post-baseline
Parent Feeding Practices
12-months post-baseline
- +1 more secondary outcomes
Study Arms (3)
EMI
EXPERIMENTALEMI (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
EXPERIMENTALEMI + 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
EXPERIMENTALEMI + 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.
Interventions
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.
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.
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.
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..
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Children with medically necessary dietary restrictions.
- Non-custodial parents, who the child does not live with more than 50% of the time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- National Institutes of Health (NIH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Minnesotacollaborator
Study Sites (2)
University of Colorado Anschutz Medical Campus--ACCORDS
Aurora, Colorado, 80045, United States
University of Minnesota--Department of Family Social Science
Minneapolis, Minnesota, 55414, United States
Related Publications (2)
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.
PMID: 37072737BACKGROUNDBerge 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.
PMID: 36993265DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Like most behavioral interventions, it is not possible to double blind this RCT because interventionists will be delivering the in-home visiting components to participants. However, the proposed study incorporates participant, study staff, physician, and investigator blinding as much as possible. The intervention will be administered by trained staff assigned to the intervention team, who will not be involved with evaluation team responsibilities/meetings. Evaluation team members will carry out all measurement home visits and will be blinded to participant study arm assignment. They will not be involved with intervention team responsibilities/meetings. Specific co-investigators are responsible for training and supervising staff within the intervention team versus the evaluation team in to order to blind as many co-investigators as possible.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2016
First Posted
February 1, 2016
Study Start
February 11, 2022
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 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 NHLBI policy for data sharing).
- Access Criteria
- As specified by NHLBI, 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.
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.