Childhood ObesityNCT03189979
Club Fit: Physical Activity and Healthy Eating at an After School Program
A study testing Physical activity and healthy eating intervention in people with Childhood Obesity and Physical Activity, run by Mayo Clinic at 1 site in United States.
Trial summary
Background: Youth from low-income and minority families are disproportionately affected by obesity and its complications. This study presented pilot work to develop and implement a multi-component physical activity and healthy eating intervention at a Boys \& Girls Club (BGC) after school program. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Childhood Obesity, Physical Activity, Dietary Habits
- What is being tested?
- Physical activity and healthy eating intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to May 2016
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Active Boys \& Girls Club participation, which was defined as expected Club attendance at least twice weekly.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Boys & Girls Club of Rochester, MN
Rochester, Minnesota, 55905
About this study
Official title: Club Fit: Pilot Testing of a Physical Activity and Healthy Eating Intervention at a Boys & Girls Club After School Program
Background: Youth from low-income and minority families are disproportionately affected by obesity and its complications. This study presented pilot work to develop and implement a multi-component physical activity and healthy eating intervention at a Boys \& Girls Club (BGC) after school program.
Methods: Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. Preliminary intervention efficacy was assessed through a single group, pre-post study design with measured collected at baseline and 6 months.
- Conditions
- Childhood Obesity, Physical Activity, Dietary Habits
- Being tested
- Physical activity and healthy eating intervention
- Keywords
- community based participatory research, Childhood obesity
- Medical subject headings
- Pediatric Obesity, Motor Activity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity and healthy eating interventionBehavioural
Also called Club Fit
Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign.
| Study group | Role | What they receive |
|---|---|---|
| Club Fit | Experimental | Intervention includes exposure to physical activity and healthy eating intervention policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. Receives: Behavioral: Physical activity and healthy eating intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-efficacy
Self-efficacy was assessed with a survey adapted from instruments developed for the Patient-centered Assessment and Counseling for Exercise plus Nutrition program for low-income, ethnically diverse adolescents. It was scored on a 10-point Likert scale from 1 (not at all confident) to 10 (extremely confident).
Measured: baseline, 6 months
Change in motivation
Motivation for physical activity was scored on a 10-point Likert scale from 1 (not at all motivated) to 10 (extremely motivated).
Measured: baseline, 6 months
Secondary outcomes (3)
Change in body mass index
For body mass index (BMI), weight was measured to the nearest 0.1 kg using a single scale. Height was measured to the nearest 0.1 cm using a stadiometer. BMI was calculated as weight (kg)/height squared (m2).
Measured: baseline, 6 months
Change in physical activity
The Kinetic Activity Monitor accelerometer was used for objective physical activity assessment. Participants were asked to wear the accelerometer at their waist during waking hours for 10 consecutive days. The accelerometer was activated and data collected without providing feedback to participants. A valid assessment required 5 days of wear for at least 10 hours a day. Data output included sedentary time and time spent performing mild, moderate, and vigorous physical activities.
Measured: baseline, 6 months
Change in dietary quality
Dietary assessment was performed with the Beverage and Snack Questionnaire 2. The instrument was adapted to include nine items (on a 7-point Likert scale) that addressed consumption of fruits, vegetables, and sugar sweetened beverages. The Likert scale ranged from "never or less than 1 per week" to "4+ per day." The greater number of fruits and vegetables, and fewer number of sugar sweetened beverages were considered a positive change in dietary quality.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study startOct 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark L Wieland, Mayo Clinic
- Investigators
- Mark L Wieland, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189979
- Sponsor's protocol ID
- 14-003639
- Other IDs
- UL1TR000135
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Club Fit: Pilot Testing of a Physical Activity and Healthy Eating Intervention at a Boys & Girls Club After School Program
- ClinicalTrials.gov ID
- NCT03189979
- Acronym / sponsor ID
- 14-003639
- Conditions
- Childhood Obesity, Physical Activity, Dietary Habits
- Keywords
- community based participatory research, Childhood obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Jun 2017 (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.
Background: Youth from low-income and minority families are disproportionately affected by obesity and its complications. This study presented pilot work to develop and implement a multi-component physical activity and healthy eating intervention at a Boys \& Girls Club (BGC) after school program.
Methods: Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. Preliminary intervention efficacy was assessed through a single group, pre-post study design with measured collected at baseline and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Club Fit | Experimental | Behavioral: Physical activity and healthy eating interventionIntervention includes exposure to physical activity and healthy eating intervention policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Active Boys \& Girls Club participation, which was defined as expected Club attendance at least twice weekly.
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 |
|---|---|---|
| Physical activity and healthy eating interventionAlso: Club FitUsing a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign. | Behavioural | Club Fit |
Primary outcome
Change in self-efficacy
Time frame: baseline, 6 months
Self-efficacy was assessed with a survey adapted from instruments developed for the Patient-centered Assessment and Counseling for Exercise plus Nutrition program for low-income, ethnically diverse adolescents. It was scored on a 10-point Likert scale from 1 (not at all confident) to 10 (extremely confident).
Change in motivation
Time frame: baseline, 6 months
Motivation for physical activity was scored on a 10-point Likert scale from 1 (not at all motivated) to 10 (extremely motivated).
3 secondary outcomes
Change in body mass index
Time frame: baseline, 6 months
Change in physical activity
Time frame: baseline, 6 months
Change in dietary quality
Time frame: baseline, 6 months
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 16 Jun 2017.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Mark L Wieland, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity and healthy eating intervention in people with Childhood Obesity and Physical Activity, run by Mayo Clinic 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 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 16 Jun 2017. 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?
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?
Change in self-efficacy (time frame: baseline, 6 months). The study lists 2 primary outcomes in all. 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 16 Jun 2017.