Clinical trial NCT02724839: Supporting Together Exercise and Play and Improving Nutrition
Official title: Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active.

Detailed description: In addition to the group nutrition sessions, the investigators will give a Fitbit to each of a parent and child dyad, which will be used to track and motivate their activity. The investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (TV)/ videos screen time

Eligibility criteria: Inclusion Criteria:

* Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay)
* BMI is greater than 85th%ile for age and sex
* English speaking
* have access to a computer/internet or a smart phone (for uploading Fitbit data)

Exclusion Criteria:

* Have been seen in a weight management clinic within the last 2 years
* prescribed an atypical antipsychotic
* non-ambulatory

Primary outcomes:
measure: Attendance
timeFrame: Baseline, 3 months
measure: Overall Satisfaction With Group Nutrition Sessions
timeFrame: Baseline, 3 months
measure: Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: PedsQL (Pediatric Quality of Life Inventory)
timeFrame: Baseline, 3 months
measure: BMI Z-Score
timeFrame: Baseline, 3 months
measure: Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
timeFrame: baseline, 3 months
measure: Child Self-efficacy Related to Physical Activity
timeFrame: Baseline, 3 months
measure: Child Intention to be Active
timeFrame: baseline, 3 months
measure: Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Kristen A Copeland
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saunders RP, Pate RR, Felton G, Dowda M, Weinrich MC, Ward DS, Parsons MA, Baranowski T. Development of questionnaires to measure psychosocial influences on children's physical activity. Prev Med. 1997 Mar-Apr;26(2):241-7. doi: 10.1006/pmed.1996.0134.