N/A
N=36
Supporting Together Exercise and Play and Improving Nutrition
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02724839 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Attendance — 11; 8; 2; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group nutrition sessions (Behavioral); Fitbit (Device)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Attendance |
11; 8; 2; 12; 8; 2 | — |
| PRIMARY Overall Satisfaction With Group Nutrition Sessions |
4.82; 4.68; 4.79 | — |
| PRIMARY Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens. |
— | — |
| SECONDARY PedsQL (Pediatric Quality of Life Inventory) |
72; 74 | — |
| SECONDARY BMI Z-Score |
1.84; 2.15 | — |
| SECONDARY Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale) |
— | — |
| SECONDARY Child Self-efficacy Related to Physical Activity |
1.71; 2.07; 1.71; 1.43 | — |
| SECONDARY Child Intention to be Active |
4.00; 4.00; 4.00; 4.50 | — |
| SECONDARY Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02724839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.