Pediatric Obesity Treatment in a Safety Net Clinic: Piloting the Step by Step Program
Step by Step: A Family-Centered Healthy Lifestyle Intervention
1 other identifier
interventional
16
0 countries
N/A
Brief Summary
Obesity treatment interventions have been studied in pediatric primary care offices and are often conducted in low-income and minority populations, and pediatric obesity clinics. Key components of programs that have been shown to be effective include parent engagement providing physical activity, nutrition and behavior education and at least 26 hours of total contact time. However, there is little guidance in the literature describing translation of successful programs into sustainable, real-world practice for uninsured children and families. To the investigator's knowledge no studies in the United States have evaluated the feasibility of implementing a fitness and nutrition program in safety net clinics where uninsured parents and their children receive health care. The objectives of this project were to design an evidence-based, family-centered fitness and nutrition program and evaluate the feasibility and acceptability of implementing this program in a Volunteer in Medicine Clinic, discussing successes, challenges and lessons learned.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2012
Shorter than P25 for not_applicable
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 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2012
CompletedFirst Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedMarch 5, 2020
March 1, 2020
6 months
February 25, 2020
March 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Attendance at Sessions
Numerator: Number of Families attending/Denominator: Number of sessions Numerator: Number of Fathers AttendingDenominator: Number of Sessions Numerator: Number of Children attending/Denominator: Number of sessions.
22 weeks
Secondary Outcomes (1)
BMI
22 weeks
Study Arms (1)
Step by Step Program
EXPERIMENTALThirteen 1.5 hour weekday educational sessions, five 1-hour weekday fitness classes and seventeen 1 hour weekend walks/farmer's market trips were scheduled over 22 weeks. The planned total contact time was 41.5 hours, above the minimum effective amount and recommended by the USPSTF. Children participated in all activities. Weekly text messages with motivational messages and reminders were planned. Educational Topics included: Intro and Goal Setting How to Read Nutrition Labels How to Build a Healthy Meal Choose My Plate/Walking for Fitness Healthy Fast Food Add More Fruits/Vegetables to Meals Add More Physical Activity Each Day Healthy Snacks and Drinks Healthy Desserts Circuit Training at Home Favorite Recipe Makeover Step by Step Jeopardy Celebration of Completion
Interventions
Eligibility Criteria
You may qualify if:
- Families were eligible if at least one parent and one child received healthcare at CVIM with a BMI of \>75%ile for age
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Community Volunteers In Medicinelead
- American Academy of Pediatricscollaborator
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatrician
Study Record Dates
First Submitted
February 25, 2020
First Posted
March 5, 2020
Study Start
June 12, 2012
Primary Completion
December 17, 2012
Study Completion
December 17, 2012
Last Updated
March 5, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
We are not sharing any individual participant data