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Completed

NCT Number: NCT02767440

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Families on Track Intervention

Behavioral

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.

Primary outcomes

  1. change in parent weight over 6 months

    Time frame: baseline, 6 months

Secondary outcomes

  1. change in parent BMI over 6 months

    Time frame: baseline, 6 months

  2. change in parent waist circumference over 6 months

    Time frame: baseline, 6 months

  3. change in parent blood pressure over 6 months

    Time frame: baseline, 6 months

  4. change in child lipid panel (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) over 6 months

    Time frame: baseline, 6 months

  5. change in child glucose, insulin, and HbA1c over 6 months

    Time frame: baseline, 6 months

  6. change in child z-BMI over 6 months

    Time frame: baseline, 6 months

  7. change in child blood pressure over 6 months

    Time frame: baseline, 6 months

  8. change in child cardiovascular fitness/physical conditioning

    Time frame: baseline, 6 months

    measured by 3-minute step test, 1-minute recovery heart rate over 6 months

  9. change in parent diet over 6 months

    Time frame: baseline, 6 months

    as measured by a Food Frequency Questionnaire

  10. change in parent exercise behaviors over 6 months

    Time frame: baseline, 6 months

    as measured by Paffenbarger Exercise Habits Questionnaire

  11. change in child consumption of sugar sweetened beverages over 6 months

    Time frame: baseline, 6 months

    as measured by a Food Frequency Questionnaire

  12. change in child consumption of fruits and vegetables over 6 months

    Time frame: baseline, 6 months

    as measured by a Food Frequency Questionnaire

  13. change in child consumption of sugary snacks over 6 months

    Time frame: baseline, 6 months

    as measured by a Food Frequency Questionnaire

  14. change in child number of minutes of physical activity

    Time frame: baseline, 6 months

    measured by the Physical Activity Questionnaire for Children

  15. change in child number of minutes of screen time

    Time frame: baseline, 6 months

    measured by the Physical Activity Questionnaire for Children

  16. change in parent depression over 6 months

    Time frame: baseline, 6 months

    measured by Patient Health Questionnaire (PHQ-8)

  17. change in child quality of life over 6 months

    Time frame: baseline, 6 months

    measured by Sizing Me Up sub-scales

  18. change in child perceived healthy eating and physical activity social/environmental support over 6 months

    Time frame: baseline, 6 months

  19. change in parent perceived healthy eating and physical activity social/environmental support over 6 months

    Time frame: baseline, 6 months

  20. change in home food environment over 6 months

    Time frame: baseline, 6 months

    measured by Home Food Inventory

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 10, 2016
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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