CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Group nutrition sessions +1 morebehavioral
Likely dose
Group nutrition sessions (6 sessions) and Fitbit Flex wearable device for up to 9 months of physical activity trackingAI-extracted
Key inclusion· 4
  • BMI greater than 85th percentile for age and sex
  • English speaking
  • Access to computer/internet or smartphone for Fitbit data upload
  • Primary medical home at the Pediatric Primary Care Center
Key exclusion· 3
  • Prior weight management clinic visit within 2 years
  • Current atypical antipsychotic medication
  • Non-ambulatory

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02724839
NCT02724839N/ACompleted

Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care

Children's Hospital Medical Center, Cincinnati·interventional·Posted Mar 31, 2016·Updated Nov 27, 2020

In Brief

A clinical study evaluating Group nutrition sessions and Fitbit for Obesity. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 31, 2016
Enrollment StartJun 1, 2015
Primary CompletionOct 1, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.3 years ago

Interventions

Group nutrition sessionsbehavioral

The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).

Fitbitdevice

Parent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.