ObesitySTEP INNCT02724839

Supporting Together Exercise and Play and Improving Nutrition

A study testing Group nutrition sessions and Fitbit in people with Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

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

The purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active. Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Obesity
What is being tested?: Group nutrition sessions and Fitbit
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Jun 2015to Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay)
BMI is greater than 85th%ile for age and sex
English speaking
have access to a computer/internet or a smart phone (for uploading Fitbit data)

Who cannot join

Have been seen in a weight management clinic within the last 2 years
prescribed an atypical antipsychotic
non-ambulatory

Trial locations and contacts

1 site in 1 country.

United States1 site

Pediatric Primary Care Center (PPC) Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

Official title: Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care

Read the detailed description

In addition to the group nutrition sessions, the investigators will give a Fitbit to each of a parent and child dyad, which will be used to track and motivate their activity. The investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (TV)/ videos screen time

Conditions: Obesity
Being tested: Group nutrition sessions, Fitbit
Medical subject headings: Obesity

What participants receive

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

Group nutrition sessionsBehavioural
Also called Peer-led Group Sessions
The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
FitbitDevice
Parent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.

Study groups in NCT02724839
Study group	Role	What they receive
Biweekly Arm	Experimental	6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place biweekly. Receives: Behavioral: Group nutrition sessions; Device: Fitbit
Monthly Arm	Experimental	6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place monthly. Receives: Behavioral: Group nutrition sessions; Device: Fitbit
Weekly	Experimental	6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place weekly. Receives: Behavioral: Group nutrition sessions; Device: Fitbit

What is being measured

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

Attendance
Evaluation of participant attendance in each arm.
Measured: Baseline, 3 months
Overall Satisfaction With Group Nutrition Sessions
Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.
Measured: Baseline, 3 months
Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Measured: Baseline, 3 months

Secondary outcomes (6)

PedsQL (Pediatric Quality of Life Inventory)
Measure Description: PedsQL (Pediatric Quality of Life Inventory) is a modular instrument for measuring health-related quality of life in children and adolescents ages 2 to 18. Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better Health-Related Quality of Life.
Measured: Baseline, 3 months
BMI Z-Score
BMI Z-scores compares child to age and sex matched peers. A z-score of 0 is the same as a 50th percentile in the reference population, a z-score of ± 1.0 plots at the 15th or 85th percentiles, respectively, and a z-score of ± 2 plots at roughly the 3rd or 97th percentiles. Negative numbers indicate values lower than the reference population whereas positive numbers indicate values higher than the reference population.
Measured: Baseline, 3 months
Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
The description of the overall satisfaction variable is described in outcome #2 under primary outcomes.
Measured: baseline, 3 months
Child Self-efficacy Related to Physical Activity
Self efficacy was assessed using a validated 14-item questionnaire using a 5-point Strongly Agree/ Strongly Disagree scale. The range of values is 1 to 5, with lower values indicating higher self-efficacy
Measured: Baseline, 3 months
Child Intention to be Active
Child intention to be active was assessed with a 1-item questionnaire developed and validated by Saunders et al. This item uses a 5-point scale, with possible range of scores being 1 to 5. Higher scores indicate greater intention to be active.
Measured: baseline, 3 months
Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.
Measured: Baseline, 3 months

Timeline

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

Jun 2015Dec 2018

First posted31 Mar 2016 (estimated)
Study startJun 2015
Primary completionOct 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02724839
Sponsor's protocol ID: 2015-3406
Acronym: STEP IN
Status last verified: Jan 2019
First submitted: 14 Mar 2016
Last updated: 27 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: This was a small, iterative feasibility study as a precursor to a larger clinical trial.

Publications

Saunders RP, Pate RR, Felton G, Dowda M, Weinrich MC, Ward DS, Parsons MA, Baranowski T. Development of questionnaires to measure psychosocial influences on children's physical activity. Prev Med. 1997 Mar-Apr;26(2):241-7. doi: 10.1006/pmed.1996.0134.
PubMed 9085394

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Innovations in the Management of Obesity and Inactivity in Pediatric Primary Care
ClinicalTrials.gov ID: NCT02724839
Acronym / sponsor ID: STEP IN / 2015-3406
Conditions: Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
Study start: Jun 2015 (actual)
Primary completion: Oct 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 31 Mar 2016 (estimated)
Results: Posted 3 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Biweekly Arm	Experimental	Behavioral: Group nutrition sessions, Device: Fitbit6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place biweekly.
Monthly Arm	Experimental	Behavioral: Group nutrition sessions, Device: Fitbit6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place monthly.
Weekly	Experimental	Behavioral: Group nutrition sessions, Device: Fitbit6 group nutrition sessions co-led by a peer and a content expert, Fitbit given to parent-child dyads during second session. Sessions took place weekly.

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Patients whose primary medical home is the Pediatric Primary Care Center (primarily Medicaid or self-pay)
BMI is greater than 85th%ile for age and sex
English speaking
have access to a computer/internet or a smart phone (for uploading Fitbit data)

Key exclusion criteria (3 listed)

Have been seen in a weight management clinic within the last 2 years
prescribed an atypical antipsychotic
non-ambulatory

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
Group nutrition sessionsAlso: Peer-led Group SessionsThe intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).	Behavioural	Biweekly Arm, Monthly Arm, Weekly
FitbitParent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.	Device	Biweekly Arm, Monthly Arm, Weekly

Primary outcome

Attendance
Time frame: Baseline, 3 months
Evaluation of participant attendance in each arm.
Overall Satisfaction With Group Nutrition Sessions
Time frame: Baseline, 3 months
Participants evaluated their satisfaction with the group sessions using a 5 point scale with a score of 1 being complete dissatisfaction and 5 being the greatest satisfaction.
Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.
Time frame: Baseline, 3 months
Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.

6 secondary outcomes

PedsQL (Pediatric Quality of Life Inventory)
Time frame: Baseline, 3 months
BMI Z-Score
Time frame: Baseline, 3 months
Number of Participants Reporting They Were Satisfied With the Group Nutrition Sessions (4 or 5 on 5-point Likert Scale)
Time frame: baseline, 3 months
Child Self-efficacy Related to Physical Activity
Time frame: Baseline, 3 months
Child Intention to be Active
Time frame: baseline, 3 months
Change From Baseline in Parent-reported Number of Hours of Screen Time Child Watches Daily
Time frame: Baseline, 3 months

Results and safety

Results posted to the registry on 3 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biweekly Arm	13	12
Monthly Arm	12	8
Weekly Arm	11	6

Primary outcome: Attendance

Time frame: Baseline, 3 months. Count of participants. Unit: Participants

Measure	Biweekly Arm n = 12	Monthly Arm n = 8	Weekly Arm n = 6
Number of Participants in Attendance at Session 1	11	8	2
Number of Participants in Attendance at Session 2	12	8	2
Number of Participants in Attendance at Session 3	8	7	3
Number of Participants in Attendance at Session 4	10	4	6
Number of Participants in Attendance at Session 5	11	6	4
Number of Participants in Attendance at Session 6	8	5	6

Primary outcome: Overall Satisfaction With Group Nutrition Sessions

Time frame: Baseline, 3 months. Mean (Full Range). Unit: score on a scale

Measure	Biweekly Arm n = 12	Monthly Arm n = 8	Weekly Arm n = 6
Value	4.82 (4 to 5)	4.68 (4 to 5)	4.79 (4 to 5)

Primary outcome: Change From Baseline in Parent-report Child's Daily Servings of Fruits and Vegetables and Time Spent on Screens.

Time frame: Baseline, 3 months

Population analysed: Data were not collected on any participants because we changed the study design based on qualitative participant feedback in pilot phases. Our asking participants about their habits, and showing them their data, was part of the intervention instead of an outcome to assess efficacy of the intervention.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biweekly Arm	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Monthly Arm	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Weekly Arm	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): Small number of subjects analyzed. Difficulty recruiting and retaining engaged participants for collection of all desired outcome measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9085394Saunders RP, Pate RR, Felton G, Dowda M, Weinrich MC, Ward DS, Parsons MA, Baranowski T. Development of questionnaires to measure psychosocial influences on children's physical activity. Prev Med. 1997 Mar-Apr;26(2):241-7. doi: 10.1006/pmed.1996.0134.
Individual participant dataSharing planned: No. This was a small, iterative feasibility study as a precursor to a larger clinical trial.

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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.

Kristen A Copeland principal investigator

Children's Hospital Medical Center, Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group nutrition sessions and Fitbit in people with Obesity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.

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 4 inclusion and 3 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 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: Baseline, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02724839, which also lists 1 linked publication.

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 27 Nov 2020.