Clinical trial NCT03961061: Increased Monitoring of Physical Activity and Calories With Technology
Official title: Increased Monitoring of Physical Activity and Calories With Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Change, Body
Behavior, Health
Obesity, Childhood
Parent-Child Relations
Keywords: weight management
pediatric weight management
mHealth
mobile technology
parent/child relations
dyad
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-05-23
Enrollment: 28
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control group will receive standard Brenner FIT care. The intervention group will receive standard Brenner FIT care in additional to mobile health components in the hopes of maximizing the benefits that are already seen with pediatric weight management programs like Brenner FIT.
Primary purpose: TREATMENT

Brief summary: Since severe obesity in youth has been steadily increasing. Specialized pediatric obesity clinics provide programs to aid in reducing obesity. Since the home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during behavioral weight loss interventions, a family-based treatment approach is best. This strategy has been moderately successful in our existing, evidence-based pediatric weight management program, Brenner Families In Training (Brenner FIT). However, since programs such as Brenner Families in Training rely on face-to-face interactions and delivery, they are sometimes by the time constraints experienced by families. Therefore, the purpose of this study is to develop and pilot a tailored, mobile health component to potentially increase the benefits seen by Brenner FIT standard program components and similar pediatric weight management programs.

Detailed description: For this project, we will randomize 80 youth with obesity (13 - 18yrs) and a caregiver (dyads) to the Brenner Families in Training (FIT) group or the Brenner Families in Training Mobile (mFIT) group. All youth participants will receive a commercially available activity monitor. Caregivers will receive podcasts with a story about a caregiver supporting weight loss in a child by providing healthy foods/activities for his/her family, including healthy eating and physical activity information. Children will receive animated videos that contain healthy eating and physical activity messaging, with an engaging story of a child losing weight. All participants will have access to a website and mobile apps where they will track weight, diet, and physical activity for themselves (youth) or their child (parents). Based on their reports of weight, eating, and physical activity, the messaging received from clinical staff by the families will be individually tailored to promote healthy behaviors and overcome perceived barriers. The proposed research is innovative in that it explicitly incorporates theory into the intervention and evaluation components of the project and builds upon an existing literature on mobile health interventions that use mobile technology.

Eligibility criteria: Inclusion Criteria:

Youth with obesity, 13 - 18yrs, who are enrolled or eligible to enroll in Brenner Families in Training (FIT). Caregivers must live in the home with their youth participants. Obesity is defined a BMI (35.9 +/- 8.6). Participants must also have access to a smartphone or tablet

Exclusion Criteria:

Adolescents under the age of 13 will be excluded. If participants do not have access to a smartphone or tablet, they will not be able to participate.

Primary outcomes:
measure: BMI Percentile
timeFrame: Baseline
measure: BMI Percentile
timeFrame: 3 months
measure: BMI Percentile
timeFrame: 6 months
Secondary outcomes:
measure: Physical Activity Via Accelerometry (Bouts of Physical Activity)
timeFrame: Baseline
measure: Physical Activity Via Accelerometry (Bouts of Physical Activity)
timeFrame: 3 months
measure: Physical Activity Via Accelerometry (Bouts of Physical Activity)
timeFrame: 6 months
measure: ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool
timeFrame: Baseline
measure: ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool
timeFrame: 3 months
measure: ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool
timeFrame: 6 months
measure: Economic Costs of the Two Intervention Arms
timeFrame: Through study completion (6 months)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Brenner Children's Hospital
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Justin B Moore, PhD
role: PRINCIPAL_INVESTIGATOR
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