Environmental Influences on Early Childhood Obesity

NCT02703688 | Completed DMC

• 2 other identifiers: 14-1975K23DK087826
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Few treatments have been developed for young children with obesity from diverse backgrounds. The present study will develop and test an intervention designed to improve preschool obesity in Latino children. The intervention will focus on improving eating, activity, and sleep behaviors and the home environment for improved weight status.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• Change in BMI

  BMI and % over the 95th percentile will be determined using scales

  Baseline, 2.5 months, 12 months

Secondary Outcomes (5)

• Change in Caregiver's Feeding Styles Questionnaire

  Baseline, 2.5 months, 12 months

• Change in Child caloric intake

  Baseline, 2.5 months, 12 months

• Change in Sleep duration

  Baseline, 2.5 months, 12 months

• Change in Home sleep environment

  Baseline, 2.5 months, 12 months

• Change in Home food environment

  Baseline, 2.5 months, 12 months

Study Arms (2)

Healthy Homes

EXPERIMENTAL

Behavioral Intervention

Behavioral: Healthy Homes

Usual Care

ACTIVE COMPARATOR

Counseling session delivered by pediatrician

Other: Usual Care

Interventions

Healthy Homes BEHAVIORAL

The Healthy Homes Behavioral Intervention (HHBI) will be delivered during 8 sessions over 10 weeks using home visitations. The first 6 sessions occur weekly and provide education about healthy dietary intake including caloric recommendations for preschool aged children, healthy sleep goals, active play and screen time limits, and family routines and organization. Each session will include a parent-child interaction component to teach child behavior management skills related to intervention goals. Two final sessions occur every other week to provide problem solving and planning for maintenance of treatment effects.

Healthy Homes

Usual Care OTHER

A pediatrician with experience delivering weight management treatment to children will deliver a single session, 1-hour treatment to families. Content to be delivered during the session will include lifestyle recommendations currently recommended by the AAP.

Usual Care

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• mothers will identify themselves as being Latino
• obese preschool children will be required to have a BMI percentile at or above the 95th percentile, based on sex specific, BMI-for-age population referenced growth charts
• participating children will be required to have at least one primary caregiver who is English-speaking as their primary language and live within 50 miles of the UCD for the initial treatment development phase (n=3) and at least one family who is Spanish speaking (n=1). However, all families participating in the randomized portion can also be exclusively Spanish speaking.

You may not qualify if:

• Children with medical conditions known to promote obesity will be excluded along with individuals involved with a weight-control program or those taking appetite-affecting medications
• Children who are greater than 100% overweight
• Children will be excluded who have a reported disability, illness, or disorder that would significantly affect diet or activity behaviors
• children identified by parents with significant food allergies
• involvement with Stage II, structured weight management for obesity.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard E Boles, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 9, 2016
• Study Start: September 15, 2011
• Primary Completion: March 31, 2014
• Study Completion: March 31, 2014
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

US (1)