Comparing Outcomes Among Children With Obesity in a Community Healthy Lifestyle Program
Status
Conditions
Treatments
Details and patient eligibility
About
This study aims to evaluate the outcomes of an existing clinical program that teaches families of children with overweight and obesity healthy lifestyle. The design will be unblinded, randomized, waitlist control.
Full description
The participants will come from the cohort of patients who are referred to the Get Up & Go program and decide to enroll. For this existing family healthy weight program, the child must be between 6 and 14 years of age at time of program start, with BMI by report of ≥ 85th percentile. The child must be able to participate in physical activity comparable to an elementary school PE class and must be able to function cognitively at or above the level of a 6 year old.
The process for enrollment in this program begins with a standard referral that goes to the Get Up & Go office at Children's Health. Staff will make referred families aware of study at initial contact; staff generally place a call to families to give overview of Get Up & Go. Office staff tell interested families that they will be contacted closer to the time of class start. Whether or not the family answers the phone, the family is mailed a welcome packet.
For the study, the Get Up & Go staff will inform families by phone that they may qualify for a study that performs additional measures to help understand the effect of the program. These families will hear that study participation is optional. The staff will tell the families that a study coordinator will call or text unless the family says they do not want to be contacted. The welcome packet will include a page with the same information and an opt-out postcard. To enroll in this study, the parent must speak English or Spanish.
The study coordinator will call families who have not declined contact, up to 5 times at different times of day. When they reach the family, they will review the study protocol and invite participation. The coordinator will review the study protocol, explaining that participation will mean a 1-hour visit measure several weeks prior to class start and agreement to accept randomization to immediate start or 3 months deferment. If family wants to enroll, the consent will be reviewed, and all questions answered. The parent will verbally consent and will receive a copy of the (unsigned per IRB waiver) consent via email. The child will assent. If families prefer, they can defer consent or assent until the in-person appointment for measurement.
A study coordinator will schedule a time 1-4 weeks before the start of the Get Up & Go class to meet with a small group (1-5) of study families at either the YMCA or at Children's Health to perform baseline measures. If any families were interested but did not consent virtually, they will undergo consenting process at this time. When measures (see description below) are complete, a simple 1:1 randomization will be done, using a computer software program that generates random sequence. Neither research team nor family will be blinded to assignment
- Intervention: immediate participation
- Control: Waitlist, deferring participation for approximately 3 months, to the next quarter
The wait list control subjects will receive no intervention for 3 months. They will undergo a Time 2 measure and then begin participation in the session at the subsequent quarter.
Data collected will include height, weight, %BMIp95, endurance via PACER test. Survey data: The Family and Nutrition and Physical Activity (FNPA) and Behavior Assessment Questionnaire (BAQ).
Optional data: Parental height, weight, and BMI.
Each quarter, approximately 40 families will be enrolled, with 20 randomized to start immediately and 20 to wait until the subsequent quarter. Cohorts will be recruited each quarter for 4-5 quarters until enrollment is complete.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- BMI by report of ≥ 85th percentile
- The child must be able to participate in physical activity comparable to an elementary school PE class and must be able to function cognitively at or above the level of a 6 year old
Exclusion criteria
- BMI by report of below the 85th percentile
- Inability to participate in physical activity comparable to an elementary school PE class and must be able to function cognitively at or above the level of a 6 year old
Parent will be invited but not required to be weighed and measured.
Trial design
Primary purpose
Allocation
Interventional model
Masking
160 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Victoria Nelson; Sarah E Barlow, MD, MPH
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal