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Completed

NCT Number: NCT01419951

Launch II: A Pilot Randomized Control Trial of a Clinic and Clinic Plus Home Intervention for Preschool Obesity

The objective of this project is to pilot test a behavioral intervention that includes a home visit component compared to a clinic only and standard of care for the treatment of obesity in preschool age children. The results of this study will inform the design of a larger randomized control trial.

H1: The clinic + home intervention will result in a significantly greater decrease in BMIz compared to the in clinic only intervention or pediatric standard of care at 6 months post-treatment.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 2 years 0 months to 5 years 11 months of age
  • at or above the 95th percentile BMI for age and sex
  • have at least one parent with a BMI at or greater than 25
  • medical clearance from pediatrician

Exclusion criteria

  • non-English speaking
  • living greater than 50 miles from medical center
  • a disability or illness that would preclude engagement in moderate activity
  • medical condition/medication associated with weight
  • enrolled in another weight management program

Treatment and study plan

Clinic + Home Behavioral Intervention

Behavioral

A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.

Pediatrician Counseling

Other

A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.

Clinic Only Behavioral Intervention

Behavioral

A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.

Primary outcomes

  1. Change in BMI z score

    Time frame: Change from Baseline to 6 months

    Body mass index z score

Secondary outcomes

  1. Change in Parent weight loss

    Time frame: Change from baseline to 6 months

  2. Change in Child caloric intake

    Time frame: Change from baseline to 6 months

  3. Change in Home food and activity environment

    Time frame: Change from baseline to 6 months

  4. Change in Child physical activity

    Time frame: Change from baseline to 6 months

  5. Change in Parent-child mealtime interactions

    Time frame: Change from baseline to 6 months

  6. Change in Health related quality of life

    Time frame: Change from baseline to 6 months

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Center for Research Resources (NCRR)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

LAUNCH II: Learning About Activity and Understanding Nutrition for Better Child Health

Important dates

Study start
2009
Primary completion
2011
Study completion
2014
First posted
Aug 18, 2011
Registry last updated
Oct 22, 2014

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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