ObesityNCT02767440
Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity
A study testing Families on Track Intervention in people with Obesity and Childhood Obesity, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood Obesity, Hypertension
- What is being tested?
- Families on Track Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 29 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Pediatrics Healthy Lifestyles Clinic
Durham, NC, North Carolina, 27704
About this study
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).
Read the 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.
- Conditions
- Obesity, Childhood Obesity, Hypertension, Diabetes, Dyslipidemia
- Being tested
- Families on Track Intervention
- Medical subject headings
- Obesity, Pediatric Obesity, Hypertension, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Families on Track InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Families on Track Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in parent weight over 6 months
Measured: baseline, 6 months
Secondary outcomes (20)
change in parent BMI over 6 months
Measured: baseline, 6 months
change in parent waist circumference over 6 months
Measured: baseline, 6 months
change in parent blood pressure over 6 months
Measured: baseline, 6 months
change in child lipid panel (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) over 6 months
Measured: baseline, 6 months
change in child glucose, insulin, and HbA1c over 6 months
Measured: baseline, 6 months
change in child z-BMI over 6 months
Measured: baseline, 6 months
change in child blood pressure over 6 months
Measured: baseline, 6 months
change in child cardiovascular fitness/physical conditioning
measured by 3-minute step test, 1-minute recovery heart rate over 6 months
Measured: baseline, 6 months
change in parent diet over 6 months
as measured by a Food Frequency Questionnaire
Measured: baseline, 6 months
change in parent exercise behaviors over 6 months
as measured by Paffenbarger Exercise Habits Questionnaire
Measured: baseline, 6 months
change in child consumption of sugar sweetened beverages over 6 months
as measured by a Food Frequency Questionnaire
Measured: baseline, 6 months
change in child consumption of fruits and vegetables over 6 months
as measured by a Food Frequency Questionnaire
Measured: baseline, 6 months
change in child consumption of sugary snacks over 6 months
as measured by a Food Frequency Questionnaire
Measured: baseline, 6 months
change in child number of minutes of physical activity
measured by the Physical Activity Questionnaire for Children
Measured: baseline, 6 months
change in child number of minutes of screen time
measured by the Physical Activity Questionnaire for Children
Measured: baseline, 6 months
change in parent depression over 6 months
measured by Patient Health Questionnaire (PHQ-8)
Measured: baseline, 6 months
change in child quality of life over 6 months
measured by Sizing Me Up sub-scales
Measured: baseline, 6 months
change in child perceived healthy eating and physical activity social/environmental support over 6 months
Measured: baseline, 6 months
change in parent perceived healthy eating and physical activity social/environmental support over 6 months
Measured: baseline, 6 months
change in home food environment over 6 months
measured by Home Food Inventory
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Armstrong, MD, Principal investigator, Duke University Health System, Duke Healthy LifestylesDori M Steinberg, PhD, RD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767440
- Sponsor's protocol ID
- Pro00072648
- Status last verified
- Apr 2017
- First submitted
- 6 May 2016
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families on Track: A Digital Health Behavioral Intervention for Parents Seeking Treatment for Their Child With Obesity
- ClinicalTrials.gov ID
- NCT02767440
- Acronym / sponsor ID
- Pro00072648
- Conditions
- Obesity, Childhood Obesity, Hypertension, Diabetes, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 10 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Families on Track Intervention | Experimental | Behavioral: Families on Track InterventionThis 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-60 years
- BMI: 25-50 kg/m2
- English speaking
- Mobile phone ownership
- Willingness to send and receive multiple text messages/day
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Families on Track InterventionParents 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. | Behavioural | Families on Track Intervention |
Primary outcome
change in parent weight over 6 months
Time frame: baseline, 6 months
20 secondary outcomes
change in parent BMI over 6 months
Time frame: baseline, 6 months
change in parent waist circumference over 6 months
Time frame: baseline, 6 months
change in parent blood pressure over 6 months
Time frame: baseline, 6 months
change in child lipid panel (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) over 6 months
Time frame: baseline, 6 months
change in child glucose, insulin, and HbA1c over 6 months
Time frame: baseline, 6 months
change in child z-BMI over 6 months
Time frame: baseline, 6 months
change in child blood pressure over 6 months
Time frame: baseline, 6 months
change in child cardiovascular fitness/physical conditioning
Time frame: baseline, 6 months
change in parent diet over 6 months
Time frame: baseline, 6 months
change in parent exercise behaviors over 6 months
Time frame: baseline, 6 months
change in child consumption of sugar sweetened beverages over 6 months
Time frame: baseline, 6 months
change in child consumption of fruits and vegetables over 6 months
Time frame: baseline, 6 months
change in child consumption of sugary snacks over 6 months
Time frame: baseline, 6 months
change in child number of minutes of physical activity
Time frame: baseline, 6 months
change in child number of minutes of screen time
Time frame: baseline, 6 months
change in parent depression over 6 months
Time frame: baseline, 6 months
change in child quality of life over 6 months
Time frame: baseline, 6 months
change in child perceived healthy eating and physical activity social/environmental support over 6 months
Time frame: baseline, 6 months
change in parent perceived healthy eating and physical activity social/environmental support over 6 months
Time frame: baseline, 6 months
change in home food environment over 6 months
Time frame: baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Armstrong, MD principal investigator
Duke University Health System, Duke Healthy Lifestyles
Dori M Steinberg, PhD, RD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Families on Track Intervention in people with Obesity and Childhood Obesity, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in parent weight over 6 months (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.