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

NCT02767440 | Completed DMC

• 1 other identifier: Pro00072648
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Childhood Obesity; Hypertension; Diabetes; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• change in parent weight over 6 months

  baseline, 6 months

Secondary Outcomes (20)

• change in parent BMI over 6 months

  baseline, 6 months

• change in parent waist circumference 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

Study Arms (1)

Families on Track Intervention

EXPERIMENTAL

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.

Behavioral: Families on Track Intervention

Interventions

Families on Track Intervention 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.

Families on Track Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Pediatrics Healthy Lifestyles Clinic

Durham, NC, North Carolina, 27704, United States

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Hypertension; Diabetes Mellitus; Dyslipidemias

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Study Officials

• Sarah Armstrong, MD

  Duke University Health System, Duke Healthy Lifestyles

  PRINCIPAL INVESTIGATOR

• Dori M Steinberg, PhD, RD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 29, 2017
• Last Updated: October 4, 2017

Record last verified: 2017-04

Locations

US (1)