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Search / Trial NCT02669797

Family Matters Intervention

Launched by UNIVERSITY OF COLORADO, DENVER · Jan 27, 2016

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

Childhood Obesity Ecological Momentary Intervention Video Feedback Cardiovascular Disease Cardiovascular Health Community Health Worker Home Visiting Virtual Hybrid

ClinConnect Summary

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 a fam...

Gender

ALL

Eligibility criteria

  • STUDY INCLUSION CRITERIA
  • The inclusionary criteria used to select participants for the proposed study includes:
  • 1. Boys and girls (n=500) ages 5-10 years old who attend a University of Minnesota Physicians (n=4) or Fairview (n=8) primary care clinic and their primary caregiver (e.g., mother, father, grandparent) and at least one sibling. A second primary caregiver and other family members can also participate.
  • 2. 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 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).
  • 3. Child with age and sex adjusted BMI ≥75th percentile (no upper limit).
  • 4. 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.
  • 5. Parent and family members who speak English or Spanish.
  • 6. Not expected to move within the next two years.
  • STUDY EXCLUSION CRITERIA
  • The exclusionary criteria used to exclude participants from the proposed study includes:
  • 1. Children with medically necessary dietary restrictions (reviewed by MD from primary care clinics).
  • 2. Non-custodial parents, who the child does not live with more than 50% of the time.

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Aurora, Colorado, United States

Minneapolis, Minnesota, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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