Competency Based Approaches for Community Health 2
One-size-fits-all approaches have failed to demonstrate sustained effects on childhood obesity, especially among low-income minority families, who experience constantly changing barriers to engaging in health behavior. Addressing obesity in these populations requires intervening in early childhood and situating interventions in the context of families and communities. Developing personalized childhood obesity prevention interventions with sustained effectiveness that support families in health behaviors despite dynamic barriers could address chronic disease risk and health disparities in low-income and minority communities.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 18 November 2021
🗓️ Primary Completion (Estimated) June 2026
✅ Study Completion (Estimated) June 2026
👥 Enrollment (Estimated) 300
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * child with an age ≥4 years and \<7 years;
    • * index parent/legal guardian with an age ≥18 years;
    • * English- or Spanish-speaking;
    • * self-identify as Hispanic/Latino;
    • * live in a home where Spanish is spoken;
    • * include an index parent/legal guardian with a body mass index of ≥25kg/m2 and \<55 kg/m2;
    • * include a child with a body mass index ≥5th percentile percentile for age and gender on standardized CDC growth curves;
    • * for participants intending to attend intervention sessions in person: reside within or frequent (i.e. work in or regularly visit) one of the following zip codes: South Nashville/Regions 1 and 2 (37013, 37204, 37210, 37211, 37217, 37220, 37076, 37086, 37167): surrounding the Coleman Recreation Center and Southeast Recreation Center; and Northeast Nashville/Madison/Region 3 (37115, 37138, 37072, 37207, 37216); for participants intending to attend intervention sessions via videoconference: participants may reside in any zip code;
    • * have parental commitment to participate in a two-year research study;
    • * have consistent mobile phone access;
    • * are without medical conditions necessitating limited physical activity as evaluated by a pre-screen;
    • * complete baseline data collection, including parent and child height and weight and at least 90% of baseline survey items;
    • * are considered underserved, measured by parent-self reporting that they or someone in their household are eligible for or participate in one of these programs or services: TennCare, CoverKids, WIC, Food Stamps (SNAP), Free and Reduced Price School Lunch and Breakfast, and/or Families First (TANF)

    Exclusion Criteria:

    • * Children outside the specified age range
    • * Children who are \<5th percentile on standardized CDC growth curves
    • * Children who do not speak English or Spanish
    • * Children who are diagnosed with medical illnesses where regular exercise might be contraindicated
    • * Children who display dissenting behaviors during baseline assent or anthropometric data collection
    • * Children who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen
    • * Children who are diagnosed with autism
    • Caregiver exclusion criteria include:
    • * Parents/legal guardians who are \<18 years old;
    • * Parents/legal guardians with serious mental or neurologic illness that impairs ability to consent/participate;
    • * Parents/legal guardians with poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).
    • * Parents/legal guardians with BMI \<25kg/m2 or BMI ≥55kg/m2
    • * Parents/legal guardians who are diagnosed with medical illnesses where regular exercise might be contraindicated
    • * Lack of parental commitment to participate consistently for a two-year period
    • * Lack of telephone contact
    • * Parents/legal guardians who do not otherwise meet the eligibility criteria listed in section above as determined by pre-screen
Ages Eligible for Study: 4 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 26 October 2020
  • First Submitted that Met QC Criteria 20 July 2021
  • First Posted 21 July 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 April 2024
  • Last Update Posted 24 April 2024
  • Last Verified April 2024