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OpenTrials
Completed

NCT Number: NCT01018121

Behavioral Rx & Nutrition in Pediatric Chronic Disease

The objective of this project is to pilot test a behavioral intervention for modifying the diet and physical activity patterns of overweight preschool children through improved parenting and nutritional education(LAUNCH). This intervention will be compared to standard of care for preschool overweight in the primary care setting using a randomized clinical trial design (RCT. The results of this pilot RCT will provide data integral to estimating the effect size for a more definitive RCT of the intervention in the future. The primary hypothesis is:

H1: LAUNCH will result in a significantly greater decrease in BMI z score compared to the standard of care at 12 months post-treatment.

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Key information

Conditions

Pediatric Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity 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 / Phase 2

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

  • child age between 2- 5 years;
  • child > 95th percentile BMI for age and sex 12, but not more than 100% above the mean BMI;
  • medical clearance from pediatrician; and
  • at least one parent with a BMI > 25. -

Exclusion criteria

  • non-English speaking;
  • living more than 50 miles from the medical center;
  • a disability/illness that would preclude engagement in at least moderate physical activity;
  • medical condition/medication associated with weight gain; or 5) enrolled in another weight control program.

Treatment and study plan

LAUNCH

Behavioral

A 6-month intervention consisting of two phases: Phase I (Intensive Intervention), 12 weekly sessions that alternated between group-based clinic sessions (parent and child concurrent groups) and individual home visits and Phase II (Maintenance), 12 weeks of every other week sessions, alternating between group sessions in-clinic and home sessions. Targeted 3 components: 1) Dietary education with age-specific caloric targets, healthy eating recommendations for children following the AAP guidelines used in the PC session; 2) Physical Activity education with age-specific activities for children and families; and 3) Parenting skills to achieve the diet and physical activity goals using behavioral management skills and parent modeling of eating and activity.

Pediatrician Counseling

Other

A one time 45-minute visit with a board certified pediatrician for each family that focused on the AAP guidelines for eating and physical activity for children

Primary outcomes

  1. BMI z score

    Time frame: Baseline, 6 months, 12 months

Secondary outcomes

  1. Parent weight loss

    Time frame: baseline, 24 weeks, 48 weeks

  2. Child caloric intake

    Time frame: baseline, 6 months, 12 months

  3. Home food and activity environment

    Time frame: baseline, 6 months, 12 months

  4. Child physical activity

    Time frame: baseline, 6 motnhs, 12 months

  5. Parent-child mealtime interactions

    Time frame: baseline, 6 months, 12 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

Acronym: LAUNCH

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 23, 2009
Registry last updated
Nov 23, 2009

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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