Behavioral Treatment for Obese Preschoolers

NCT01546727 | Completed Phase 3 DMC

• 2 other identifiers: R01DK0912511R01DK091251-01A1
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a 3 arm, randomized, parallel group randomized clinical trial to test a clinic and home family behavioral intervention (LAUNCH) against 1) motivational interviewing (attention control; MI) and 2) standard of care (true standard of care control; STC) with 168 children ages 2 to 5 years who meet the criteria for obesity (\>95th percentile for body mass index; BMI). Participants will be randomized to receive a 6 month intervention (LAUNCH, MI) or standard of care. The primary end-point will be change in BMI z-score at the end of treatment. The investigators will also assess maintenance of treatment gains at 6 and 12 months after treatment, and changes in factors thought to be mechanisms for change in weight (food intake and activity level), changes in the obesiogenic environment (parent weight, food intake and activity, and changes in the home food environment) and factors that could be negatively impacted (parent and child eating and feeding interactions).

Conditions

Obesity

Keywords

Preschoolers; Obesity; Behavioral Treatment

Outcome Measures

Primary Outcomes (1)

• Change in BMIz score

  Body Mass Index z-score

  Baseline to 6 months

Secondary Outcomes (8)

• Change in BMI z at follow up

  Baseline, 6 months, 12 months, 18 months

• Change in Caloric Intake

  Baseline, 6 months, 12 months, 18 months

• Change in Physical Activity

  Baseline, 6 months, 12 months, 18 months

• Change in home health environment

  Baseline, 6 months, 12 months, 18 months

• Changes in parent calorie intake

  Baseline, 6 months, 12 months, 18 months

Study Arms (3)

Family Behavioral Treatment

EXPERIMENTAL

This intervention will provide nutritional counseling for a health diet, parent training in effective child behavioral management strategies, and stimulus control of the home environment delivered via group based clinic visits and individual home visits on alternate weeks

Behavioral: Behavioral Family Intervention

Motivational Interviewing

ACTIVE COMPARATOR

This intervention will shared information with parents about their child's weight and use motivational interviewing to elicit changes parents would like to make to their child diet and activity patterns.

Behavioral: Motivational Interviewing

Standard of Care

NO INTERVENTION

Participants in this arm will be followed over time and be assessed on the primary and secondary outcomes at the same time points as the two treatment arms

Interventions

Behavioral Family Intervention BEHAVIORAL

Three months of weekly treatment delivered via alternating group based clinic visits and individual home visits followed by three months of every other week treatment alternating between clinic and home.

Also known as: LAUNCH

Family Behavioral Treatment

Motivational Interviewing BEHAVIORAL

Motivational interviewing will be delivered at the same frequency at the behavioral intervention with 4 in-person visits spaced at the first visit, month 3 and month 5. Phone calls will be conducted weekly during the first 3 months and every other week during months 4 through 6.

Also known as: MI

Motivational Interviewing

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children ages 2 years 0 months to 5 years 11 months
• BMI percentile at or above the 95th percentile for age- and gender, but no more than 100% above the median BMI for age and gender.
• English-speaking
• Live within 50 miles of Cincinnati Children's Hospital Medical Center (CCHMC)
• Medical clearance from the child's pediatrician to participate.

You may not qualify if:

• Medical conditions known to promote obesity (e.g., Prader-Willi syndrome, Cushing's syndrome)
• Already involved with another weight control program
• Taking weight-affecting medications (e.g., steroids).
• A disability or illness that would preclude them from engaging in at least moderate intensity physical activity
• Developmental disability

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (5)

• Stark LJ, Filigno SS, Kichler JC, Bolling C, Ratcliff MB, Robson SM, Simon SL, McCullough MB, Clifford LM, Stough CO, Zion C, Mara CA. Maintenance Following a Randomized Trial of a Clinic and Home-based Behavioral Intervention of Obesity in Preschoolers. J Pediatr. 2019 Oct;213:128-136.e3. doi: 10.1016/j.jpeds.2019.05.004. Epub 2019 Jun 21.

  PMID: 31230889 DERIVED

• Robson SM, Ziegler ML, McCullough MB, Stough CO, Zion C, Simon SL, Ittenbach RF, Stark LJ. Changes in diet quality and home food environment in preschool children following weight management. Int J Behav Nutr Phys Act. 2019 Feb 4;16(1):16. doi: 10.1186/s12966-019-0777-6.

  PMID: 30717746 DERIVED

• Stark LJ, Spear Filigno S, Bolling C, Ratcliff MB, Kichler JC, Robson SM, Simon SL, McCullough MB, Clifford LM, Odar Stough C, Zion C, Ittenbach RF. Clinic and Home-Based Behavioral Intervention for Obesity in Preschoolers: A Randomized Trial. J Pediatr. 2018 Jan;192:115-121.e1. doi: 10.1016/j.jpeds.2017.09.063. Epub 2017 Nov 14.

  PMID: 29150147 DERIVED

• Stark LJ, Filigno SS, Bolling C, Ratcliff MB, Kichler JC, Robson SL, Simon SL, McCullough MB, Clifford LM, Stough CO, Zion C, Ittenbach RF. Learning about Activity and Understanding Nutrition for Child Health (LAUNCH): Rationale, design, and implementation of a randomized clinical trial of a family-based pediatric weight management program for preschoolers. Contemp Clin Trials. 2017 Jan;52:10-19. doi: 10.1016/j.cct.2016.10.007. Epub 2016 Oct 21.

  PMID: 27777128 DERIVED

• Robson SM, Bolling C, McCullough MB, Stough CO, Stark LJ. A Preschool Obesity Treatment Clinical Trial: Reasons Primary Care Providers Declined Referrals. J Pediatr. 2016 Oct;177:262-266.e1. doi: 10.1016/j.jpeds.2016.06.027. Epub 2016 Jul 22.

  PMID: 27453375 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Spacecraft; Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Space Flight; Aviation; Transportation; Technology, Industry, and Agriculture; Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lori J Stark, Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 28, 2016

Record last verified: 2016-12

Locations

US (1)