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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767440
• Other study ID #: Pro00072648
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: October 2, 2017
• Start date: June 2016
• Est. completion date: June 29, 2017

Study information

• Verified date: April 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 29, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Diabetes
• Dyslipidemia
• Dyslipidemias
• Hypertension
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Duke Pediatrics Healthy Lifestyles Clinic	Durham, NC	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

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