Environmental Influences on Early Childhood Obesity

Not Applicable

Completed

• Conditions: Childhood Obesity
• Interventions: Behavioral: Healthy Homes; Other: Usual Care

• Registration Number: NCT02703688
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study Start: 2011-09-15
• Primary Completion: 2014-03-31
• Study Completion: 2014-03-31
• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Homes	Healthy Homes	Behavioral Intervention
Usual Care	Usual Care	Counseling session delivered by pediatrician

Primary Outcome Measures

Name	Time	Method
Change in BMI	Baseline, 2.5 months, 12 months	BMI and % over the 95th percentile will be determined using scales

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States