Back to resultsCHAT at HOME Pilot Study
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Person First Session
Second Caregiver
WiFi-enabled Scale
10 Core Coaching Calls Only
Sponsored by
About this trial
This is an interventional other trial for Childhood Obesity focused on measuring Parent, adolescent, coaching, weight loss
Eligibility Criteria
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Other
Other
Other
Other
Other
Other
Other
Other
Arm Label
Group 1
Group 2
Group 3
Group 4
Group 5
Group 6
Group 7
Group 8
Arm Description
In-person first session, no second caregiver, no wifi-enabled scale
In-person first session, no second caregiver, wifi-enabled scale
In-person first session, second caregiver, no wifi-enabled scale
In-person first session, second caregiver, wifi-enabled scale
No in-person first session, no second caregiver, no wifi-enabled scale. 10 core coaching calls only
No in-person first session, no second caregiver, wifi-enabled scale
No in-person first session, second caregiver, no wifi-enabled scale
No in-person first session, second caregiver, wifi-enabled scale
Outcomes
Primary Outcome Measures
Feasibility Data
Demonstrate feasibility and acceptability of the intervention components as measured by high participation rates in and satisfaction with all experimental arms.
Secondary Outcome Measures
Child BMI
Track and measure child BMI percentiles at beginning and end of study.
Full Information
NCT ID
NCT03661918
First Posted
September 5, 2018
Last Updated
September 23, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03661918
Brief Title
CHAT at HOME Pilot Study
Official Title
Changing Habits Together at Home Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 27, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Parent, adolescent, coaching, weight loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
This study is a 2 x 2 x 2 randomized clinical trial. In addition to the 10 core coaching sessions, there will be three additional components available to participants, depending on the experimental condition to which they are randomized. These potential additional components include 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.
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
In-person first session, no second caregiver, no wifi-enabled scale
Arm Title
Group 2
Arm Type
Other
Arm Description
In-person first session, no second caregiver, wifi-enabled scale
Arm Title
Group 3
Arm Type
Other
Arm Description
In-person first session, second caregiver, no wifi-enabled scale
Arm Title
Group 4
Arm Type
Other
Arm Description
In-person first session, second caregiver, wifi-enabled scale
Arm Title
Group 5
Arm Type
Other
Arm Description
No in-person first session, no second caregiver, no wifi-enabled scale. 10 core coaching calls only
Arm Title
Group 6
Arm Type
Other
Arm Description
No in-person first session, no second caregiver, wifi-enabled scale
Arm Title
Group 7
Arm Type
Other
Arm Description
No in-person first session, second caregiver, no wifi-enabled scale
Arm Title
Group 8
Arm Type
Other
Arm Description
No in-person first session, second caregiver, wifi-enabled scale
Intervention Type
Behavioral
Intervention Name(s)
In-Person First Session
Intervention Description
Conduct first session in person vs. over the phone
Intervention Type
Behavioral
Intervention Name(s)
Second Caregiver
Intervention Description
Have second caregiver participate in three coaching calls
Intervention Type
Behavioral
Intervention Name(s)
WiFi-enabled Scale
Intervention Description
Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale
Intervention Type
Behavioral
Intervention Name(s)
10 Core Coaching Calls Only
Intervention Description
Participant will receive 10 core phone coaching sessions
Primary Outcome Measure Information:
Title
Feasibility Data
Description
Demonstrate feasibility and acceptability of the intervention components as measured by high participation rates in and satisfaction with all experimental arms.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Child BMI
Description
Track and measure child BMI percentiles at beginning and end of study.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Sherwood, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CHAT at HOME Pilot Study
We'll reach out to this number within 24 hrs