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Completed

NCT Number: NCT03661918

CHAT 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.

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Key information

Conditions

Childhood Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Weight Loss

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-Person First Session

Behavioral

Conduct first session in person vs. over the phone

Second Caregiver

Behavioral

Have second caregiver participate in three coaching calls

WiFi-enabled Scale

Behavioral

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

10 Core Coaching Calls Only

Behavioral

Participant will receive 10 core phone coaching sessions

Primary outcomes

  1. 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.

Secondary outcomes

  1. Child BMI

    Time frame: 4 months

    Track and measure child BMI percentiles at beginning and end of study.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Changing Habits Together at Home Pilot Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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