CHAT at HOME Pilot Study

NCT ID: NCT03661918

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-27

Study Completion Date

2019-09-01

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.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

In-person first session, no second caregiver, no wifi-enabled scale

Group Type OTHER

In-Person First Session

Intervention Type BEHAVIORAL

Conduct first session in person vs. over the phone

Group 2

In-person first session, no second caregiver, wifi-enabled scale

Group Type OTHER

In-Person First Session

Intervention Type BEHAVIORAL

Conduct first session in person vs. over the phone

WiFi-enabled Scale

Intervention Type BEHAVIORAL

Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale

Group 3

In-person first session, second caregiver, no wifi-enabled scale

Group Type OTHER

In-Person First Session

Intervention Type BEHAVIORAL

Conduct first session in person vs. over the phone

Second Caregiver

Intervention Type BEHAVIORAL

Have second caregiver participate in three coaching calls

Group 4

In-person first session, second caregiver, wifi-enabled scale

Group Type OTHER

In-Person First Session

Intervention Type BEHAVIORAL

Conduct first session in person vs. over the phone

Second Caregiver

Intervention Type BEHAVIORAL

Have second caregiver participate in three coaching calls

WiFi-enabled Scale

Intervention Type BEHAVIORAL

Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale

Group 5

No in-person first session, no second caregiver, no wifi-enabled scale. 10 core coaching calls only

Group Type OTHER

10 Core Coaching Calls Only

Intervention Type BEHAVIORAL

Participant will receive 10 core phone coaching sessions

Group 6

No in-person first session, no second caregiver, wifi-enabled scale

Group Type OTHER

WiFi-enabled Scale

Intervention Type BEHAVIORAL

Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale

Group 7

No in-person first session, second caregiver, no wifi-enabled scale

Group Type OTHER

Second Caregiver

Intervention Type BEHAVIORAL

Have second caregiver participate in three coaching calls

Group 8

No in-person first session, second caregiver, wifi-enabled scale

Group Type OTHER

Second Caregiver

Intervention Type BEHAVIORAL

Have second caregiver participate in three coaching calls

WiFi-enabled Scale

Intervention Type BEHAVIORAL

Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale

Interventions

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In-Person First Session

Conduct first session in person vs. over the phone

Intervention Type BEHAVIORAL

Second Caregiver

Have second caregiver participate in three coaching calls

Intervention Type BEHAVIORAL

WiFi-enabled Scale

Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale

Intervention Type BEHAVIORAL

10 Core Coaching Calls Only

Participant will receive 10 core phone coaching sessions

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy Sherwood, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004193

Identifier Type: -

Identifier Source: org_study_id

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