Supporting Together Exercise and Play and Improving Nutrition
STEP IN
Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Jun 2015
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedResults Posted
Study results publicly available
November 3, 2020
CompletedNovember 27, 2020
January 1, 2019
3.3 years
March 14, 2016
April 14, 2020
November 13, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Attendance
Evaluation of participant attendance in each arm.
Baseline, 3 months
Overall Satisfaction With Group Nutrition Sessions
Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.
Baseline, 3 months
Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Baseline, 3 months
Secondary Outcomes (6)
PedsQL (Pediatric Quality of Life Inventory)
Baseline, 3 months
BMI Z-Score
Baseline, 3 months
Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
baseline, 3 months
Child Self-efficacy Related to Physical Activity
Baseline, 3 months
Child Intention to be Active
baseline, 3 months
- +1 more secondary outcomes
Study Arms (3)
Biweekly Arm
EXPERIMENTAL6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place biweekly.
Monthly Arm
EXPERIMENTAL6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place monthly.
Weekly
EXPERIMENTAL6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place weekly.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Have been seen in a weight management clinic within the last 2 years
- prescribed an atypical antipsychotic
- non-ambulatory
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (1)
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.
PMID: 9085394BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Small number of subjects analyzed. Difficulty recruiting and retaining engaged participants for collection of all desired outcome measures.
Results Point of Contact
- Title
- Dr.Kristen Copeland
- Organization
- Cincinnati Children's Hospital Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Kristen A Copeland
Children's Hospital Medical Center, Cincinnati
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2016
First Posted
March 31, 2016
Study Start
June 1, 2015
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
November 27, 2020
Results First Posted
November 3, 2020
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share
This was a small, iterative feasibility study as a precursor to a larger clinical trial.