Clinical trial NCT03661918: CHAT at HOME Pilot Study
Official title: Changing Habits Together at Home Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Parent, adolescent, coaching, weight loss
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Feasibility Data
timeFrame: 4 months
Secondary outcomes:
measure: Child BMI
timeFrame: 4 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Nancy Sherwood, PhD
role: PRINCIPAL_INVESTIGATOR
References: