Clinical trial NCT02767440: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Childhood Obesity
Hypertension
Diabetes
Dyslipidemia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in parent weight over 6 months
timeFrame: baseline, 6 months
Secondary outcomes:
measure: change in parent BMI over 6 months
timeFrame: baseline, 6 months
measure: change in parent waist circumference over 6 months
timeFrame: baseline, 6 months
measure: change in parent blood pressure over 6 months
timeFrame: baseline, 6 months
measure: change in child lipid panel (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) over 6 months
timeFrame: baseline, 6 months
measure: change in child glucose, insulin, and HbA1c over 6 months
timeFrame: baseline, 6 months
measure: change in child z-BMI over 6 months
timeFrame: baseline, 6 months
measure: change in child blood pressure over 6 months
timeFrame: baseline, 6 months
measure: change in child cardiovascular fitness/physical conditioning
timeFrame: baseline, 6 months
measure: change in parent diet over 6 months
timeFrame: baseline, 6 months
measure: change in parent exercise behaviors over 6 months
timeFrame: baseline, 6 months
measure: change in child consumption of sugar sweetened beverages over 6 months
timeFrame: baseline, 6 months
measure: change in child consumption of fruits and vegetables over 6 months
timeFrame: baseline, 6 months
measure: change in child consumption of sugary snacks over 6 months
timeFrame: baseline, 6 months
measure: change in child number of minutes of physical activity
timeFrame: baseline, 6 months
measure: change in child number of minutes of screen time
timeFrame: baseline, 6 months
measure: change in parent depression over 6 months
timeFrame: baseline, 6 months
measure: change in child quality of life over 6 months
timeFrame: baseline, 6 months
measure: change in child perceived healthy eating and physical activity social/environmental support over 6 months
timeFrame: baseline, 6 months
measure: change in parent perceived healthy eating and physical activity social/environmental support over 6 months
timeFrame: baseline, 6 months
measure: change in home food environment over 6 months
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Durham, NC
country: United States
facility: Duke Pediatrics Healthy Lifestyles Clinic
state: North Carolina
Study officials:
affiliation: Duke University Health System, Duke Healthy Lifestyles
name: Sarah Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Dori M Steinberg, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: