NCT04297228

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2012

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

February 25, 2020

Last Update Submit

March 3, 2020

Conditions

Keywords

pediatric obesitysafety net clinicpatient centerednutrition therapybody weight

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

EXPERIMENTAL

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

Behavioral: Step by Step: A Family-Centered Healthy Lifestyle Intervention

Interventions

Eligibility Criteria

Age4 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Related Links

MeSH Terms

Conditions

Pediatric ObesityOverweightObesityBody Weight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot Program to Implement a Family Centered Pediatric Obesity Treatment Program in a Safety Net Clinic using Goal Setting Principles and Behavior Change Theory
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