CHAT at HOME Pilot Study

September 23, 2019 updated by: University of Minnesota

Changing Habits Together at Home Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility Data
Time Frame: 4 months
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
Time Frame: 4 months
Track and measure child BMI percentiles at beginning and end of study.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Nancy Sherwood, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2018

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004193

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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