Clinical Trials Directory

Trials / Completed

CompletedNCT02724839

Supporting Together Exercise and Play and Improving Nutrition

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Children's Hospital Medical Center, Cincinnati · Academic / Other
Sex
All
Age
6 Years – 12 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALGroup nutrition sessionsThe 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).
DEVICEFitbitParent 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.

Timeline

Start date
2015-06-01
Primary completion
2018-10-01
Completion
2018-12-01
First posted
2016-03-31
Last updated
2020-11-27
Results posted
2020-11-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02724839. Inclusion in this directory is not an endorsement.