CHAT at HOME Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Changing Habits Together at Home Pilot Study

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: In-Person First Session
* Behavioral: Second Caregiver
* Behavioral: WiFi-enabled Scale
* Behavioral: 10 Core Coaching Calls Only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>In-person first session, no second caregiver, no wifi-enabled scale | Behavioral: In-Person First Session<br>* Conduct first session in person vs. over the phone<br>|
| Other: Group 2<br>In-person first session, no second caregiver, wifi-enabled scale | Behavioral: In-Person First Session<br>* Conduct first session in person vs. over the phone<br>Behavioral: WiFi-enabled Scale<br>* Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale<br>|
| Other: Group 3<br>In-person first session, second caregiver, no wifi-enabled scale | Behavioral: In-Person First Session<br>* Conduct first session in person vs. over the phone<br>Behavioral: Second Caregiver<br>* Have second caregiver participate in three coaching calls<br>|
| Other: Group 4<br>In-person first session, second caregiver, wifi-enabled scale | Behavioral: In-Person First Session<br>* Conduct first session in person vs. over the phone<br>Behavioral: Second Caregiver<br>* Have second caregiver participate in three coaching calls<br>Behavioral: WiFi-enabled Scale<br>* Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale<br>|
| Other: Group 5<br>No in-person first session, no second caregiver, no wifi-enabled scale. 10 core coaching calls only | Behavioral: 10 Core Coaching Calls Only<br>* Participant will receive 10 core phone coaching sessions<br>|
| Other: Group 6<br>No in-person first session, no second caregiver, wifi-enabled scale | Behavioral: WiFi-enabled Scale<br>* Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale<br>|
| Other: Group 7<br>No in-person first session, second caregiver, no wifi-enabled scale | Behavioral: Second Caregiver<br>* Have second caregiver participate in three coaching calls<br>|
| Other: Group 8<br>No in-person first session, second caregiver, wifi-enabled scale | Behavioral: Second Caregiver<br>* Have second caregiver participate in three coaching calls<br>Behavioral: WiFi-enabled Scale<br>* Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child BMI | Track and measure child BMI percentiles at beginning and end of study. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parent, adolescent, coaching, weight loss