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Clinical Trials/NCT02767440
NCT02767440
Completed
N/A

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

Duke University1 site in 1 country50 target enrollmentJune 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Duke University
Enrollment
50
Locations
1
Primary Endpoint
change in parent weight over 6 months
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
June 29, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

change in parent weight over 6 months

Time Frame: baseline, 6 months

Secondary Outcomes

  • change in parent waist circumference over 6 months(baseline, 6 months)
  • change in parent BMI over 6 months(baseline, 6 months)
  • change in parent blood pressure over 6 months(baseline, 6 months)
  • change in child lipid panel (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) over 6 months(baseline, 6 months)
  • change in child glucose, insulin, and HbA1c over 6 months(baseline, 6 months)
  • change in parent exercise behaviors over 6 months(baseline, 6 months)
  • change in child number of minutes of physical activity(baseline, 6 months)
  • change in child z-BMI over 6 months(baseline, 6 months)
  • change in child cardiovascular fitness/physical conditioning(baseline, 6 months)
  • change in child consumption of fruits and vegetables over 6 months(baseline, 6 months)
  • change in child number of minutes of screen time(baseline, 6 months)
  • change in parent depression over 6 months(baseline, 6 months)
  • change in parent perceived healthy eating and physical activity social/environmental support over 6 months(baseline, 6 months)
  • change in home food environment over 6 months(baseline, 6 months)
  • change in child blood pressure over 6 months(baseline, 6 months)
  • change in child consumption of sugar sweetened beverages over 6 months(baseline, 6 months)
  • change in parent diet over 6 months(baseline, 6 months)
  • change in child consumption of sugary snacks over 6 months(baseline, 6 months)
  • change in child quality of life over 6 months(baseline, 6 months)
  • change in child perceived healthy eating and physical activity social/environmental support over 6 months(baseline, 6 months)

Study Sites (1)

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