- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02767440
Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Durham, NC, North Carolina, United States, 27704
- Duke Pediatrics Healthy Lifestyles Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in parent weight over 6 months
Time Frame: baseline, 6 months
|
baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in parent BMI over 6 months
Time Frame: baseline, 6 months
|
baseline, 6 months
|
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change in parent waist circumference over 6 months
Time Frame: baseline, 6 months
|
baseline, 6 months
|
|
change in parent blood pressure over 6 months
Time Frame: baseline, 6 months
|
baseline, 6 months
|
|
change in child lipid panel (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) over 6 months
Time Frame: baseline, 6 months
|
baseline, 6 months
|
|
change in child glucose, insulin, and HbA1c over 6 months
Time Frame: baseline, 6 months
|
baseline, 6 months
|
|
change in child z-BMI over 6 months
Time Frame: baseline, 6 months
|
baseline, 6 months
|
|
change in child blood pressure over 6 months
Time Frame: baseline, 6 months
|
baseline, 6 months
|
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change in child cardiovascular fitness/physical conditioning
Time Frame: baseline, 6 months
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measured by 3-minute step test, 1-minute recovery heart rate over 6 months
|
baseline, 6 months
|
change in parent diet over 6 months
Time Frame: baseline, 6 months
|
as measured by a Food Frequency Questionnaire
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baseline, 6 months
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change in parent exercise behaviors over 6 months
Time Frame: baseline, 6 months
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as measured by Paffenbarger Exercise Habits Questionnaire
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baseline, 6 months
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change in child consumption of sugar sweetened beverages over 6 months
Time Frame: baseline, 6 months
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as measured by a Food Frequency Questionnaire
|
baseline, 6 months
|
change in child consumption of fruits and vegetables over 6 months
Time Frame: baseline, 6 months
|
as measured by a Food Frequency Questionnaire
|
baseline, 6 months
|
change in child consumption of sugary snacks over 6 months
Time Frame: baseline, 6 months
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as measured by a Food Frequency Questionnaire
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baseline, 6 months
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change in child number of minutes of physical activity
Time Frame: baseline, 6 months
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measured by the Physical Activity Questionnaire for Children
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baseline, 6 months
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change in child number of minutes of screen time
Time Frame: baseline, 6 months
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measured by the Physical Activity Questionnaire for Children
|
baseline, 6 months
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change in parent depression over 6 months
Time Frame: baseline, 6 months
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measured by Patient Health Questionnaire (PHQ-8)
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baseline, 6 months
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change in child quality of life over 6 months
Time Frame: baseline, 6 months
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measured by Sizing Me Up sub-scales
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baseline, 6 months
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change in child perceived healthy eating and physical activity social/environmental support over 6 months
Time Frame: baseline, 6 months
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baseline, 6 months
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change in parent perceived healthy eating and physical activity social/environmental support over 6 months
Time Frame: baseline, 6 months
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baseline, 6 months
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change in home food environment over 6 months
Time Frame: baseline, 6 months
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measured by Home Food Inventory
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baseline, 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah Armstrong, MD, Duke University Health System, Duke Healthy Lifestyles
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00072648
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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