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Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity

Primary Purpose

Obesity, Childhood Obesity, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Families on Track Intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age: 18-60 years
  • BMI: 25-50 kg/m2
  • English speaking
  • Mobile phone ownership
  • Willingness to send and receive multiple text messages/day
  • living in the same household as a Healthy Lifestyles patient ages 2-16

Exclusion Criteria:

  • Current pregnancy or lactation
  • Prior or planned bariatric surgery Both child and parent participation in other obesity trials - including the evaluation of the Bull City Fit Program at the Healthy Lifestyles program
  • History of heart attack, stroke, bipolar disorder schizophrenia or recent cancer diagnosis
  • Plans to relocate within 1 year

Sites / Locations

  • Duke Pediatrics Healthy Lifestyles Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Families on Track Intervention

Arm Description

This is a pre-post study. Enrolled parents will receive the Families on Track intervention plus usual care at the Healthy Lifestyles clinic at Duke University.

Outcomes

Primary Outcome Measures

change in parent weight over 6 months

Secondary Outcome Measures

change in parent BMI over 6 months
change in parent waist circumference over 6 months
change in parent blood pressure over 6 months
change in child lipid panel (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) over 6 months
change in child glucose, insulin, and HbA1c over 6 months
change in child z-BMI over 6 months
change in child blood pressure over 6 months
change in child cardiovascular fitness/physical conditioning
measured by 3-minute step test, 1-minute recovery heart rate over 6 months
change in parent diet over 6 months
as measured by a Food Frequency Questionnaire
change in parent exercise behaviors over 6 months
as measured by Paffenbarger Exercise Habits Questionnaire
change in child consumption of sugar sweetened beverages over 6 months
as measured by a Food Frequency Questionnaire
change in child consumption of fruits and vegetables over 6 months
as measured by a Food Frequency Questionnaire
change in child consumption of sugary snacks over 6 months
as measured by a Food Frequency Questionnaire
change in child number of minutes of physical activity
measured by the Physical Activity Questionnaire for Children
change in child number of minutes of screen time
measured by the Physical Activity Questionnaire for Children
change in parent depression over 6 months
measured by Patient Health Questionnaire (PHQ-8)
change in child quality of life over 6 months
measured by Sizing Me Up sub-scales
change in child perceived healthy eating and physical activity social/environmental support over 6 months
change in parent perceived healthy eating and physical activity social/environmental support over 6 months
change in home food environment over 6 months
measured by Home Food Inventory

Full Information

First Posted
May 6, 2016
Last Updated
October 2, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02767440
Brief Title
Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity
Official Title
Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Current models of outpatient childhood obesity treatment focus on the child's health habits, with limited efficacy. In part, this may be because childhood obesity is highly sensitive to parental lifestyle habits, who are often not a direct target of child obesity interventions. This study aims to target weight loss among overweight parents of 2-16 year old children with obesity enrolled in the Duke Healthy Lifestyles Program (HL) in order to augment child body mass index reduction. The intervention, " Families on Track" is a digital health intervention platform using the Interactive Obesity Treatment Approach (iOTA).
Detailed Description
Parents in the program will receive the family-based treatment protocol provided by the Healthy Lifestyles clinic. First, families attend a half-day session at the clinic where child anthropometrics and labs are obtained, and nutrition and physical activity group counseling is provided. Height and weight of the primary adult caregiver are measured and BMI is calculated. Second, families return 2 weeks later to meet individually with a pediatric obesity medical provider and a registered dietitian. Thereafter, frequency of visits is determined based on the families needs with a final visit 1 year after starting treatment. The ideal is to have visits with the HL staff at intervals of 4-6 weeks for 5 more visits to complete the primary phase of the program over 6 months. Parents enrolled in the study will also receive the Track intervention. The investigators will use a modified version of the Track intervention, which utilized the Interactive Obesity Treatment Approach (iOTA). iOTA uses a computer algorithm to assign 3-4 personalized behavioral goals known to create an energy deficit to produce weight loss (e.g., sugary drinks, fast food consumption walk 10,000 steps/day, etc). The team at Duke Digital Health has shown that iOTA can be successfully delivered to adults on multiple modalities -- web, text messaging and interactive voice response phone calls. Each week, participants will receive a prompt from the Track intervention system in order to self-monitoring these behaviors goals. These prompts will be delivered either via interactive voice response or text message. Intervention participants will also receive an analog bathroom scale and a pedometer to self-monitor daily weights and steps.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood Obesity, Hypertension, Diabetes, Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Families on Track Intervention
Arm Type
Experimental
Arm Description
This is a pre-post study. Enrolled parents will receive the Families on Track intervention plus usual care at the Healthy Lifestyles clinic at Duke University.
Intervention Type
Behavioral
Intervention Name(s)
Families on Track Intervention
Intervention Description
Parents will receive the standard of care activities at the Healthy Lifestyles clinic at Duke University. They will also receive a modified version of the previously conducted Track intervention, a digital health weight loss intervention for adults in community health centers . The intervention will utilize the Interactive Obesity Treatment Approach (iOTA). iOTA uses a computer algorithm to assign 3 personalized behavioral goals known to create an energy deficit to produce weight loss (e.g., sugary drinks, fast food consumption walk 10,000 steps/day, etc). Participants will track these goals via interactive voice response (IVR) and text messaging technologies each week. They will receive immediate feedback based on self-monitoring data and skills training videos to learn how to make the behavioral changes necessary for weight loss. Intervention participants will also receive an analog bathroom scale and a pedometer to self-monitor daily weights and steps.
Primary Outcome Measure Information:
Title
change in parent weight over 6 months
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
change in parent BMI over 6 months
Time Frame
baseline, 6 months
Title
change in parent waist circumference over 6 months
Time Frame
baseline, 6 months
Title
change in parent blood pressure over 6 months
Time Frame
baseline, 6 months
Title
change in child lipid panel (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) over 6 months
Time Frame
baseline, 6 months
Title
change in child glucose, insulin, and HbA1c over 6 months
Time Frame
baseline, 6 months
Title
change in child z-BMI over 6 months
Time Frame
baseline, 6 months
Title
change in child blood pressure over 6 months
Time Frame
baseline, 6 months
Title
change in child cardiovascular fitness/physical conditioning
Description
measured by 3-minute step test, 1-minute recovery heart rate over 6 months
Time Frame
baseline, 6 months
Title
change in parent diet over 6 months
Description
as measured by a Food Frequency Questionnaire
Time Frame
baseline, 6 months
Title
change in parent exercise behaviors over 6 months
Description
as measured by Paffenbarger Exercise Habits Questionnaire
Time Frame
baseline, 6 months
Title
change in child consumption of sugar sweetened beverages over 6 months
Description
as measured by a Food Frequency Questionnaire
Time Frame
baseline, 6 months
Title
change in child consumption of fruits and vegetables over 6 months
Description
as measured by a Food Frequency Questionnaire
Time Frame
baseline, 6 months
Title
change in child consumption of sugary snacks over 6 months
Description
as measured by a Food Frequency Questionnaire
Time Frame
baseline, 6 months
Title
change in child number of minutes of physical activity
Description
measured by the Physical Activity Questionnaire for Children
Time Frame
baseline, 6 months
Title
change in child number of minutes of screen time
Description
measured by the Physical Activity Questionnaire for Children
Time Frame
baseline, 6 months
Title
change in parent depression over 6 months
Description
measured by Patient Health Questionnaire (PHQ-8)
Time Frame
baseline, 6 months
Title
change in child quality of life over 6 months
Description
measured by Sizing Me Up sub-scales
Time Frame
baseline, 6 months
Title
change in child perceived healthy eating and physical activity social/environmental support over 6 months
Time Frame
baseline, 6 months
Title
change in parent perceived healthy eating and physical activity social/environmental support over 6 months
Time Frame
baseline, 6 months
Title
change in home food environment over 6 months
Description
measured by Home Food Inventory
Time Frame
baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 18-60 years BMI: 25-50 kg/m2 English speaking Mobile phone ownership Willingness to send and receive multiple text messages/day living in the same household as a Healthy Lifestyles patient ages 2-16 Exclusion Criteria: Current pregnancy or lactation Prior or planned bariatric surgery Both child and parent participation in other obesity trials - including the evaluation of the Bull City Fit Program at the Healthy Lifestyles program History of heart attack, stroke, bipolar disorder schizophrenia or recent cancer diagnosis Plans to relocate within 1 year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Armstrong, MD
Organizational Affiliation
Duke University Health System, Duke Healthy Lifestyles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dori M Steinberg, PhD, RD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Pediatrics Healthy Lifestyles Clinic
City
Durham, NC
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States

12. IPD Sharing Statement

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Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity

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