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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Pediatric Obesity, Overweight and Obesity
- 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 group | Role | What they receive |
|---|---|---|
| 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 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.
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)
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.
- First posted5 Mar 2020
- Study start12 Jun 2012
- Primary completion17 Dec 2012
- Study completion17 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Community Volunteers In Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics
- Responsible party
- Principal investigator, Kimberly Stone, Community Volunteers In Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step by Step: A Family-Centered Healthy Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT04297228
- Acronym / sponsor ID
- 20560
- Conditions
- Pediatric Obesity, Overweight and Obesity
- Keywords
- pediatric obesity, safety net clinic, patient centered, nutrition therapy, body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Community Volunteers In MedicineUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics
- Study start
- 12 Jun 2012 (actual)
- Primary completion
- 17 Dec 2012 (actual)
- Study completion
- 17 Dec 2012 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Step by Step Program | Experimental | Behavioral: Step by Step: A Family-Centered Healthy Lifestyle InterventionThirteen 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 |
Who may qualify
- Ages
- 4 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Families were eligible if at least one parent and one child received healthcare at CVIM with a BMI of >75%ile for age
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step by Step: A Family-Centered Healthy Lifestyle Intervention | Behavioural | Step by Step Program |
Primary outcome
Attendance at Sessions
Time frame: 22 weeks
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.
1 secondary outcome
BMI
Time frame: 22 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Community Volunteers in Medicine websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are not sharing any individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.