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Environmental Influences on Early Childhood Obesity (HHS)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Homes
Usual Care
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity

Eligibility Criteria

3 Years - 5 Years (Child)All SexesAccepts 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.

Sites / Locations

  • University of Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healthy Homes

Usual Care

Arm Description

Behavioral Intervention

Counseling session delivered by pediatrician

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 22, 2016
Last Updated
July 13, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02703688
Brief Title
Environmental Influences on Early Childhood Obesity
Acronym
HHS
Official Title
Environmental Influences on Early Childhood Obesity: The Healthy Homes Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2011 (Actual)
Primary Completion Date
March 31, 2014 (Actual)
Study Completion Date
March 31, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Homes
Arm Type
Experimental
Arm Description
Behavioral Intervention
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Counseling session delivered by pediatrician
Intervention Type
Behavioral
Intervention Name(s)
Healthy Homes
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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 Outcome Measure Information:
Title
Change in BMI
Description
BMI and % over the 95th percentile will be determined using scales
Time Frame
Baseline, 2.5 months, 12 months
Secondary Outcome Measure Information:
Title
Change in Caregiver's Feeding Styles Questionnaire
Description
Change in type of parental feeding style over time
Time Frame
Baseline, 2.5 months, 12 months
Title
Change in Child caloric intake
Description
24 hour dietary recall will identify average daily caloric intake
Time Frame
Baseline, 2.5 months, 12 months
Title
Change in Sleep duration
Description
Accelerometer will be used to determine objective estimates of sleep duration
Time Frame
Baseline, 2.5 months, 12 months
Title
Change in Home sleep environment
Description
change in sleeping environment characteristics that promote healthy sleep
Time Frame
Baseline, 2.5 months, 12 months
Title
Change in Home food environment
Description
change in home food environment characteristics that promote healthy food intake.
Time Frame
Baseline, 2.5 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E Boles, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Environmental Influences on Early Childhood Obesity

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