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

NCT ID: NCT02767440

Last Updated: 2017-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-06-29

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.

Conditions

Obesity; Childhood Obesity; Hypertension; Diabetes; Dyslipidemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Families on Track Intervention

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.

Group Type: EXPERIMENTAL

Families on Track Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Families on Track Intervention

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Armstrong, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Health System, Duke Healthy Lifestyles

Dori M Steinberg, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Pediatrics Healthy Lifestyles Clinic

Durham, NC, North Carolina, United States

Countries

United States

Other Identifiers

Pro00072648

Identifier Type: -

Identifier Source: org_study_id