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Environmental Influences on Early Childhood Obesity

Environmental Influences on Early Childhood Obesity: The Healthy Homes Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02703688
Acronym
HHS
Enrollment
129
Registered
2016-03-09
Start date
2011-09-15
Completion date
2014-03-31
Last updated
2022-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

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.

Interventions

BEHAVIORALHealthy 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.

OTHERUsual 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in BMIBaseline, 2.5 months, 12 monthsBMI and % over the 95th percentile will be determined using scales

Secondary

MeasureTime frameDescription
Change in Caregiver's Feeding Styles QuestionnaireBaseline, 2.5 months, 12 monthsChange in type of parental feeding style over time
Change in Child caloric intakeBaseline, 2.5 months, 12 months24 hour dietary recall will identify average daily caloric intake
Change in Sleep durationBaseline, 2.5 months, 12 monthsAccelerometer will be used to determine objective estimates of sleep duration
Change in Home sleep environmentBaseline, 2.5 months, 12 monthschange in sleeping environment characteristics that promote healthy sleep
Change in Home food environmentBaseline, 2.5 months, 12 monthschange in home food environment characteristics that promote healthy food intake.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026