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Pediatric ObesityNCT04297228

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

A study testing Step by Step: A Family-Centered Healthy Lifestyle Intervention in people with Pediatric Obesity and Overweight and Obesity, run by Community Volunteers In Medicine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric Obesity, Overweight and Obesity
What is being tested?
Step by Step: A Family-Centered Healthy Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
No sites listed yet
Study dates
12 Jun 2012to 17 Dec 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • none

About this study

Official title: Step by Step: A Family-Centered Healthy Lifestyle Intervention

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.

Read the 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.

Being tested
Step by Step: A Family-Centered Healthy Lifestyle Intervention
Keywords
pediatric obesity, safety net clinic, patient centered, nutrition therapy, body weight
Medical subject headings
Pediatric Obesity, Overweight, Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Step by Step: A Family-Centered Healthy Lifestyle InterventionBehavioural

Study groups in NCT04297228
Study groupRoleWhat they receive
Step by Step ProgramExperimentalThirteen 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
Receives: Behavioral: Step by Step: A Family-Centered Healthy Lifestyle Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 22 weeks

Secondary outcomes (1)
  1. BMI

    Pre and Post Intervention BMI measurements on all family

    Measured: 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2020
  2. Study start12 Jun 2012
  3. Primary completion17 Dec 2012
  4. Study completion17 Dec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04297228
Sponsor's protocol ID
20560
Status last verified
Mar 2020
First submitted
25 Feb 2020
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We are not sharing any individual participant data

Questions about this trial

What is this clinical trial studying?

A study testing Step by Step: A Family-Centered Healthy Lifestyle Intervention in people with Pediatric Obesity and Overweight and Obesity, run by Community Volunteers In Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attendance at Sessions (time frame: 22 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.

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