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Completed

NCT Number: NCT03339440

A Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity (Hearts and Parks)

The investigators propose a randomized controlled effectiveness trial to evaluate the integrated clinic-community model of child obesity treatment as compared with routine primary care.

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Key information

Conditions

Childhood Obesity Body Weight Cardiovascular Risk Factor Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Quality of Life Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Children's Primary Care Roxboro Street, Durham, North Carolina, United States

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About this study

The purpose of this study is to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) affect children's health. The investigators will be looking at changes in child BMI, physical activity, nutrition, and overall health. The investigators also hope to better understand biological differences in metabolism and the microbiome (the bacteria that grows normally on and in the body) in children with high BMI who are making lifestyle changes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child age 5-18 years
  • Child body mass index ≥ 95th %ile
  • Parent can speak and read in English or Spanish
  • Parent ownership of a device that is able to receive and send text messages

Exclusion criteria

  • Live farther than a 20-mile radius from the Healthy and Fit program site
  • Endogenous or genetic cause of obesity
  • Taking a medication that causes weight gain
  • Participation in a pediatric weight management program within 12 months
  • Parent or child significant health problem that would limit participation
  • Enrollment is above the max weekly enrollment of 60 participants/week)
  • Reported or planned pregnancy

Opt-out Criteria

  • Primary care physician opts patient out of study for reasons including: severe obesity, urgent co-morbidities, parental unwillingness to be contacted by a research assistant, or at physician clinical judgment.

Treatment and study plan

Hearts & Parks

Behavioral

The Hearts & Parks intervention will be looking to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) through attendance and participation in the Duke Healthy Lifestyles/Bull City Fit clinic/community program, affect children's health. The investigators will be looking at changes in BMI, physical activity, nutrition and overall health.

Primary outcomes

  1. Change in z-BMI

    Time frame: Baseline, 6 months

  2. Change in heart rate

    Time frame: baseline, 12 months

  3. Number of subjects enrolled versus number of subjects who meet min. participation criteria

    Time frame: 12 months

    As measured by enrollment logs

  4. Change in molecular pathways dysregulated in pediatric obesity

    Time frame: Baseline, 6 months

    Stool and blood samples

  5. Physical activity

    Time frame: Up to 12 months

    child physical activity; objectively tracked with fitness tracker

  6. Change in child fitness

    Time frame: baseline, 3 months, 12 months

    3 minute bench stepping test

  7. Change in Child Quality of Life

    Time frame: baseline, 3 months, 12 months

    Composite score of Sizing Me Up Questionnaires

  8. Change in Body Appreciation

    Time frame: baseline, 3 months, 12 months

    Body appreciation scale 13-item questionnaire (1. Never, 2. Seldom, 3. Sometimes, 4. Often, 5. Always)

  9. Change in FLASHE Food and Activity Screener Scores

    Time frame: Baseline, 6 months, 12 months

    Questionnaire about child and parent nutrition and activity habits

  10. Change in fasting lipid profile

    Time frame: Baseline, 6 months, 12 months

  11. Change in fasting glucose

    Time frame: Baseline, 6 months, 12 months

  12. Change in alanine aminotransferase (A1)

    Time frame: Baseline, 6 months, 12 months

  13. Change in child quality of life (2)

    Time frame: baseline, 3 months, 12 months

    PROMIS Questionnaire (not composite score)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

A Randomized Trial of an Integrated Clinic-community Intervention in Children and Adolescents With Obesity

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2017
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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