CHAT at HOME Pilot Study

Not Applicable

Completed

• Conditions: Childhood Obesity
• Interventions: Behavioral: Second Caregiver; Behavioral: In-Person First Session; Behavioral: 10 Core Coaching Calls Only; Behavioral: WiFi-enabled Scale

• Registration Number: NCT03661918
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-07
• Study Start: 2018-11-27
• Status Verified: 2019-09
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 7	Second Caregiver	No in-person first session, second caregiver, no wifi-enabled scale
Group 1	In-Person First Session	In-person first session, no second caregiver, no wifi-enabled scale
Group 3	In-Person First Session	In-person first session, second caregiver, no wifi-enabled scale
Group 4	WiFi-enabled Scale	In-person first session, second caregiver, wifi-enabled scale
Group 8	Second Caregiver	No in-person first session, second caregiver, wifi-enabled scale
Group 3	Second Caregiver	In-person first session, second caregiver, no wifi-enabled scale
Group 6	WiFi-enabled Scale	No in-person first session, no second caregiver, wifi-enabled scale
Group 2	In-Person First Session	In-person first session, no second caregiver, wifi-enabled scale
Group 4	In-Person First Session	In-person first session, second caregiver, wifi-enabled scale
Group 4	Second Caregiver	In-person first session, second caregiver, wifi-enabled scale
Group 8	WiFi-enabled Scale	No in-person first session, second caregiver, wifi-enabled scale
Group 2	WiFi-enabled Scale	In-person first session, no second caregiver, wifi-enabled scale
Group 5	10 Core Coaching Calls Only	No in-person first session, no second caregiver, no wifi-enabled scale. 10 core coaching calls only

Primary Outcome Measures

Name	Time	Method
Feasibility Data	4 months	Demonstrate feasibility and acceptability of the intervention components as measured by high participation rates in and satisfaction with all experimental arms.

Secondary Outcome Measures

Name	Time	Method
Child BMI	4 months	Track and measure child BMI percentiles at beginning and end of study.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States