CHAT at HOME Pilot Study

Childhood Obesity Clinical Trial

Official title:

Changing Habits Together at Home Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03661918
• Other study ID #: STUDY00004193
• Status: Completed
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is evaluating the acceptability and feasibility of a 10 session parent-targeted phone-based childhood obesity treatment (n=40). A factorial design (2 X 2 X 2) will be used to examine the acceptability and feasibility of 3 intervention components: 1) the first session being conducted in person, 2) involving a second adult caregiver, and 3) a weekly weighing of child via WiFi-enabled scales.

Description:

All participants in this study will receive 10 core coaching sessions. These sessions will be conducted between study staff and parents of children ages 8 - 12 who are in the 85th percentile or higher on the BMI scale. The sessions will focus on healthy habits and positive reinforcement for behavior changes within the house that could lead to a reduction in the the child's BMI. In addition to the 10 core sessions, some participants will have difference components of the intervention added to their treatment: conducting the first session in-person, having a second caregiver participate in some of the coaching calls, and/or having the child use a wifi-enabled scale for weekly weigh-ins.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Parent/primary caregiver of child in the 8-12 year old age range based on child birth date

• The child's BMI is greater than or equal to the 85th percentile according to CDC age and sex reference standards

• Child lives with parent/primary caregiver 50% of the time

• Willing to have a second caregiver participate in this study

• Wifi at home

• The parent and child can speak, read, and understand English

Exclusion Criteria:

• Kidney disease, Type 1 diabetes, Lupus, current Cancer diagnosis,

• Chromosomal abnormality such as Down's syndrome or Turner's syndrome

• Child taken any steroid medications such as Prednisone, Prenisilone and Decadron on a daily basis for more than 1 month in the past 6 months (this does not include inhalers with steroids)

• Child enrolled in a different weight management program

• Family participating in any other child research study related to dietary intake, physical activity, weight

• Plans to move more than 50 miles from your present location within the next 6 months

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• In-Person First Session
Conduct first session in person vs. over the phone
• Second Caregiver
Have second caregiver participate in three coaching calls
• WiFi-enabled Scale
Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale
• 10 Core Coaching Calls Only
Participant will receive 10 core phone coaching sessions

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Data	Demonstrate feasibility and acceptability of the intervention components as measured by high participation rates in and satisfaction with all experimental arms.	4 months
Secondary	Child BMI	Track and measure child BMI percentiles at beginning and end of study.	4 months