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OpenTrials
Completed

NCT Number: NCT02703688

Environmental Influences on Early Childhood Obesity

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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mothers will identify themselves as being Latino
  • 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
  • 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

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

Treatment and study plan

Healthy Homes

Behavioral

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.

Usual Care

Other

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.

Primary outcomes

  1. Change in BMI

    Time frame: Baseline, 2.5 months, 12 months

    BMI and % over the 95th percentile will be determined using scales

Secondary outcomes

  1. Change in Caregiver's Feeding Styles Questionnaire

    Time frame: Baseline, 2.5 months, 12 months

    Change in type of parental feeding style over time

  2. Change in Child caloric intake

    Time frame: Baseline, 2.5 months, 12 months

    24 hour dietary recall will identify average daily caloric intake

  3. Change in Sleep duration

    Time frame: Baseline, 2.5 months, 12 months

    Accelerometer will be used to determine objective estimates of sleep duration

  4. Change in Home sleep environment

    Time frame: Baseline, 2.5 months, 12 months

    change in sleeping environment characteristics that promote healthy sleep

  5. Change in Home food environment

    Time frame: Baseline, 2.5 months, 12 months

    change in home food environment characteristics that promote healthy food intake.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Environmental Influences on Early Childhood Obesity: The Healthy Homes Study

Acronym: HHS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 9, 2016
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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