CHAT at HOME Pilot Study

• ClinicalTrials.gov Identifier: NCT03661918
• Recruitment Status: Completed
• First Posted: September 7, 2018
• Last Update Posted: September 25, 2019
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Childhood Obesity	Behavioral: In-Person First Session; Behavioral: Second Caregiver; Behavioral: WiFi-enabled Scale; Behavioral: 10 Core Coaching Calls Only	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• 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.
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Changing Habits Together at Home Pilot Study
• Actual Study Start Date: November 27, 2018
• Actual Primary Completion Date: September 1, 2019
• Actual Study Completion Date: September 1, 2019

Arms and Interventions

Arm	Intervention/treatment
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
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
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
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: Second Caregiver; Have second caregiver participate in three coaching calls; Behavioral: WiFi-enabled Scale; 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	Behavioral: 10 Core Coaching Calls Only; Participant will receive 10 core phone coaching sessions
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
Group 7; No in-person first session, second caregiver, no wifi-enabled scale	Behavioral: Second Caregiver; Have second caregiver participate in three coaching calls
Group 8; No in-person first session, second caregiver, wifi-enabled scale	Behavioral: Second Caregiver; Have second caregiver participate in three coaching calls; Behavioral: WiFi-enabled Scale; Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Child BMI [ Time Frame: 4 months ]
   Track and measure child BMI percentiles at beginning and end of study.

Eligibility Criteria

• Ages Eligible for Study: 8 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55454

Sponsors and Collaborators

University of Minnesota

Investigators

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

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03661918
• Other Study ID Numbers: STUDY00004193
• First Posted: September 7, 2018
• Last Update Posted: September 25, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

Parent, adolescent, coaching, weight loss

Additional relevant MeSH terms:

Pediatric Obesity; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight