CHAT at HOME Pilot Study

NCT03661918 | Completed

• 1 other identifier: STUDY00004193
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Parent, adolescent, coaching, weight loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Child BMI

  4 months

Study Arms (8)

Group 1

OTHER

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

Behavioral: In-Person First Session

Group 2

OTHER

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

Behavioral: In-Person First Session; Behavioral: WiFi-enabled Scale

Group 3

OTHER

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

Behavioral: In-Person First Session; Behavioral: Second Caregiver

Group 4

OTHER

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

Behavioral: In-Person First Session; Behavioral: Second Caregiver; Behavioral: WiFi-enabled Scale

Group 5

OTHER

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

Behavioral: 10 Core Coaching Calls Only

Group 6

OTHER

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

Behavioral: WiFi-enabled Scale

Group 7

OTHER

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

Behavioral: Second Caregiver

Group 8

OTHER

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

Behavioral: Second Caregiver; Behavioral: WiFi-enabled Scale

Interventions

In-Person First Session BEHAVIORAL

Conduct first session in person vs. over the phone

Group 1; Group 2; Group 3; Group 4

Second Caregiver BEHAVIORAL

Have second caregiver participate in three coaching calls

Group 3; Group 4; Group 7; Group 8

WiFi-enabled Scale BEHAVIORAL

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

Group 2; Group 4; Group 6; Group 8

10 Core Coaching Calls Only BEHAVIORAL

Participant will receive 10 core phone coaching sessions

Group 5

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Nancy Sherwood, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: November 27, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)