Environmental Influences on Early Childhood Obesity (HHS)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Childhood Obesity

Treatments: Other: Usual Care; Behavioral: Healthy Homes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02703688

14-1975

K23DK087826 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 2 patient groups

Healthy Homes

Experimental group

Description:

Behavioral Intervention

Treatment:

Behavioral: Healthy Homes

Usual Care

Active Comparator group

Description:

Counseling session delivered by pediatrician

Treatment:

Other: Usual Care