Family Matters Intervention

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT02669797
Status
Enrolling By Invitation

Conditions

  • Cardiovascular Disease Prevention
  • Childhood Obesity

Eligibility Criteria

Sex
ALL
Age
5 Years - 10 Years
Healthy Volunteers
Accepted

Interventions

  • In-home Visits and Food Preparation Activities — BEHAVIORAL
    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 Intervention — BEHAVIORAL
    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 Meals — BEHAVIORAL
    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.
  • Maintenance — BEHAVIORAL
    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 Details

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).

Key Dates

Start date
Feb 11, 2022
Status verified
Sep 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: EMI
    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.
  • Experimental: EMI + HV + Video feedback, Virtual
    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.
  • Experimental: EMI + HV + Video feedback, Hybrid
    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.

Primary Outcome Measure

Child BMI percentile [ Time Frame: 12-months post-baseline ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical Campus--ACCORDSAuroraColorado80045-
University of Minnesota--Department of Family Social ScienceMinneapolisMinnesota55414-

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By research site
University of Colorado Anschutz Medical Campus--ACCORDS· Aurora, COUniversity of Minnesota--Department of Family Social Science· Minneapolis, MN

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