search
Back to results

Pediatric Obesity Treatment in a Safety Net Clinic: Piloting the Step by Step Program

Primary Purpose

Pediatric Obesity, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Step by Step: A Family-Centered Healthy Lifestyle Intervention
Sponsored by
Community Volunteers In Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring pediatric obesity, safety net clinic, patient centered, nutrition therapy, body weight

Eligibility Criteria

4 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Families were eligible if at least one parent and one child received healthcare at CVIM with a BMI of >75%ile for age

Exclusion Criteria:

  • none

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Step by Step Program

    Arm Description

    Thirteen 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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    BMI
    Pre and Post Intervention BMI measurements on all family

    Full Information

    First Posted
    February 25, 2020
    Last Updated
    March 3, 2020
    Sponsor
    Community Volunteers In Medicine
    Collaborators
    American Academy of Pediatrics
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04297228
    Brief Title
    Pediatric Obesity Treatment in a Safety Net Clinic: Piloting the Step by Step Program
    Official Title
    Step by Step: A Family-Centered Healthy Lifestyle Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 12, 2012 (Actual)
    Primary Completion Date
    December 17, 2012 (Actual)
    Study Completion Date
    December 17, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Community Volunteers In Medicine
    Collaborators
    American Academy of Pediatrics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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. This prospective pilot study was conducted within a Volunteers in Medicine (VIM) model clinic in Southeastern Pennsylvania from July - December 2012. The VIM Model focuses on providing primary care to children, adolescents and adults that are uninsured. This model is guided by the principles of inclusion, service and community involvement, with volunteers providing the vast majority of health care and support services. Community Volunteers in Medicine (CVIM) provides primary care and dental care to uninsured adults and children who live or work in Chester County with incomes less than 300% of the federal poverty level. In 2016, Chester County's residents were 7% Hispanic, 24% obese, 9% uninsured and 10% of children living in families with incomes below the poverty level. Most pediatric patients served by CVIM are of Hispanic/Latino descent and have a high prevalence of overweight and obesity (54%), which is higher than the county prevalence of 25% in school-aged children. After a quality improvement project identified the high prevalence of childhood obesity in children served by CVIM, the authors proposed developing a family-centered obesity treatment program. CVIM's Executive Board committed support to the program. Temple University School of Medicine's Institutional Review Board approved the project. Consent materials were available in English and Spanish. The program name Step by Step (Paso a Paso) was chosen by consensus, logo designed by a local graphic artist, and T-shirts provided to staff, volunteers and participants. Behavior change theory and goal-setting principles informed the program design. A literature review identified evidence-based best practices. Thirteen 1.5 hour weekday educational sessions, five 1-hour weekday fitness classes and seventeen 1 hour weekend activities were scheduled over 22 weeks. The planned total contact time was 41.5 hours, above the minimum effective amount recommended by the USPSTF. Children participated in all activities. Weekly text messages with motivational messages and reminders were planned. A Manual of Operations detailed the volunteer orientation, session outlines, and handouts. Sessions had bilingual staff and handouts were available in English and in Spanish. Clinic staff, volunteers and family members were encouraged to participate in fitness and nutrition activities. Staff and Volunteer Recruitment and Training Providers recruited from clinic volunteers and staff conducted enrollment histories and physical examinations. The clinic's nutrition education specialist organized cooking classes with assistance from volunteers. Volunteers recruited from an Accelerated Pre-Medicine Post Bachelor's Program at a local college completed a background check, CVIM volunteer orientation and Step by Step program orientation. Volunteers provided child supervision, assistance with physical activity and cooking classes and language support. A physician (KS) was present for every session. Participant Recruitment and Enrollment Enrollment goal was 10 families. Chart review identified eligible families; they were contacted by phone and invited to attend the enrollment meeting with a standard script. At enrollment, parents signed informed consent and children assented; parents gave permission for photography and physical activity participation. Parents and children completed baseline questionnaires on fitness and nutrition knowledge and practices. Participant histories and physicals were completed using the Pennsylvania Sports Physical Standard form. Families gave permission to receive text reminders and were given a schedule for activities and educational sessions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Obesity, Overweight and Obesity
    Keywords
    pediatric obesity, safety net clinic, patient centered, nutrition therapy, body weight

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pilot Program to Implement a Family Centered Pediatric Obesity Treatment Program in a Safety Net Clinic using Goal Setting Principles and Behavior Change Theory
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Step by Step Program
    Arm Type
    Experimental
    Arm Description
    Thirteen 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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Step by Step: A Family-Centered Healthy Lifestyle Intervention
    Primary Outcome Measure Information:
    Title
    Attendance at Sessions
    Description
    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.
    Time Frame
    22 weeks
    Secondary Outcome Measure Information:
    Title
    BMI
    Description
    Pre and Post Intervention BMI measurements on all family
    Time Frame
    22 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Families were eligible if at least one parent and one child received healthcare at CVIM with a BMI of >75%ile for age Exclusion Criteria: none

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We are not sharing any individual participant data
    Links:
    URL
    http://www.cvim.org
    Description
    Community Volunteers in Medicine website

    Learn more about this trial

    Pediatric Obesity Treatment in a Safety Net Clinic: Piloting the Step by Step Program

    We'll reach out to this number within 24 hrs