Environmental Influences on Early Childhood Obesity (HHS)

Environmental Influences on Early Childhood Obesity: The Healthy Homes Study

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.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Healthy Homes; Other: Usual Care

Detailed Description

Children from low income families of minority status are at greater risk for development of obesity. There are no known existing treatments for pediatric obesity that focus on improving parental behaviors and the home food and activity environment. The objective of this study will be to address this limitation by developing and testing a novel treatment for low-income minority families. The objective will be attained by testing the following hypothesis: A parent-focused, home-based treatment aimed at improving parental feeding behaviors, child exposure to fruits and vegetables, and the home food and activity environment will result in significantly greater decrease in percent overweight / obesity compared to recommended practice. The hypothesis will be tested by using the approach of a pilot randomized control trial (RCT). The rationale for this aim is that success of the planned research will derive a treatment package that will provide the basis for the RCT. The planned research is expected to show the level of impact of changing parental feeding behaviors and the home environment on childhood overweight / obesity.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University Of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. mothers will identify themselves as being Latino
2. 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
3. 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.

Exclusion Criteria:

1. 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
2. Children who are greater than 100% overweight
3. Children will be excluded who have a reported disability, illness, or disorder that would significantly affect diet or activity behaviors
4. children identified by parents with significant food allergies
5. involvement with Stage II, structured weight management for obesity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Homes; Behavioral Intervention	Behavioral: Healthy Homes; 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.
Active Comparator: Usual Care; Counseling session delivered by pediatrician	Other: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI	BMI and % over the 95th percentile will be determined using scales	Baseline, 2.5 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Caregiver's Feeding Styles Questionnaire	Change in type of parental feeding style over time	Baseline, 2.5 months, 12 months
Change in Child caloric intake	24 hour dietary recall will identify average daily caloric intake	Baseline, 2.5 months, 12 months
Change in Sleep duration	Accelerometer will be used to determine objective estimates of sleep duration	Baseline, 2.5 months, 12 months
Change in Home sleep environment	change in sleeping environment characteristics that promote healthy sleep	Baseline, 2.5 months, 12 months
Change in Home food environment	change in home food environment characteristics that promote healthy food intake.	Baseline, 2.5 months, 12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Richard E Boles, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2011
• Primary Completion (Actual): March 31, 2014
• Study Completion (Actual): March 31, 2014

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 14-1975; K23DK087826 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No