Clinical trial NCT02703688: Environmental Influences on Early Childhood Obesity
Official title: Environmental Influences on Early Childhood Obesity: The Healthy Homes Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-03-09
Enrollment: 129
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in BMI
timeFrame: Baseline, 2.5 months, 12 months
Secondary outcomes:
measure: Change in Caregiver's Feeding Styles Questionnaire
timeFrame: Baseline, 2.5 months, 12 months
measure: Change in Child caloric intake
timeFrame: Baseline, 2.5 months, 12 months
measure: Change in Sleep duration
timeFrame: Baseline, 2.5 months, 12 months
measure: Change in Home sleep environment
timeFrame: Baseline, 2.5 months, 12 months
measure: Change in Home food environment
timeFrame: Baseline, 2.5 months, 12 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Richard E Boles, PhD
role: PRINCIPAL_INVESTIGATOR
References: