Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity
- Conditions
- DyslipidemiaObesityChildhood ObesityHypertensionDiabetes
- Interventions
- Behavioral: Families on Track Intervention
- Registration Number
- NCT02767440
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Families on Track Intervention 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.
- Primary Outcome Measures
Name Time Method change in parent weight over 6 months baseline, 6 months
- Secondary Outcome Measures
Name Time Method 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 as measured by Paffenbarger Exercise Habits Questionnaire
change in child number of minutes of physical activity baseline, 6 months measured by the Physical Activity Questionnaire for Children
change in child z-BMI over 6 months baseline, 6 months change in child cardiovascular fitness/physical conditioning baseline, 6 months measured by 3-minute step test, 1-minute recovery heart rate over 6 months
change in child consumption of fruits and vegetables over 6 months baseline, 6 months as measured by a Food Frequency Questionnaire
change in child number of minutes of screen time baseline, 6 months measured by the Physical Activity Questionnaire for Children
change in parent depression over 6 months baseline, 6 months measured by Patient Health Questionnaire (PHQ-8)
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 measured by Home Food Inventory
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 as measured by a Food Frequency Questionnaire
change in parent diet over 6 months baseline, 6 months as measured by a Food Frequency Questionnaire
change in child consumption of sugary snacks over 6 months baseline, 6 months as measured by a Food Frequency Questionnaire
change in child quality of life over 6 months baseline, 6 months measured by Sizing Me Up sub-scales
change in child perceived healthy eating and physical activity social/environmental support over 6 months baseline, 6 months
Trial Locations
- Locations (1)
Duke Pediatrics Healthy Lifestyles Clinic
🇺🇸Durham, NC, North Carolina, United States