OverweightChallengeNCT03103269
Challenge! Adolescent Obesity Prevention
A study testing Challenge! Small Group Intervention and Challenge! Environmental Intervention in people with Overweight and Obesity, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The prevalence of overweight among adolescents (BMI-for-age %tile over the 95th percentile) has more than tripled over the past 3 decades in the US. Overweight and physical inactivity disproportionately affect low- income, female, African American adolescents. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Challenge! Small Group Intervention and Challenge! Environmental Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 789 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2014
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For small group intervention:
- Female Adolescent
- Grades 6 or 7
- No health problems that would interfere with participation in physical education classes
- For environmental intervention Health and Activity Committee:
- Must be one of the following:
Show all 10Show fewer
- 8th grade female student
- Parent or legal guardian of any student in the school
- School personnel
- Adult Community member (Self-identifies as member of specified community surrounding school)
Who cannot join
- For small group intervention:
- Male
- Outside of the grade range 6-7 at recruitment
- Participant will be excluded if they answer no to question 1 on the screening questionnaire (unable to read and understand questions written in English)
- Participant will be excluded if they answer yes to questions 2 or 3 on screening form (fails health screening due to medical condition preventing them from engaging in physical activity)
- For environmental intervention Health and Activity Committee:
- Inability to speak or read English
- Inability to attend meetings
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore City Public Schools
Baltimore, Maryland, 21201
About this study
Official title: Challenge! in Baltimore City Middle Schools
The prevalence of overweight among adolescents (BMI-for-age %tile over the 95th percentile) has more than tripled over the past 3 decades in the US. Overweight and physical inactivity disproportionately affect low- income, female, African American adolescents.
A prior health-promotion/ obesity-prevention program for adolescents developed and tested by our group (Challenge!) showed that adolescents who received the intervention were less likely to become overweight or obese over 2 years when compared to the control group. This intervention was administered one-on-one to adolescents in their homes or community by a college-aged mentor.
Read more
Schools are an ideal setting for interventions because the effect can be far-reaching and sustainable. School-based obesity-prevention interventions have thus far shown modest results.
The purpose of this study is to evaluate the impact of a multilevel intervention that includes both the Challenge program administered in a small group format after school using mentors and teachers and a school-wide environmental change on adolescent females' body composition, diet, and physical activity. The intervention is targeted to 6th and 7th grade female students. The small group intervention is conducted over 12 weeks and includes goal setting focusing on healthy diet and physical activity, along with membership and weekly trips to the YMCA. The environmental intervention includes a Health and Activity Committee (HAC), comprised of 8th grade female students (popular opinion leaders), school personnel, parents, and community members. The HAC develops school-wide health promotion messages and activities. Parents of participating 6th and 7th grade girls provide information on family variables. The hypotheses are that females who receive the small group or environmental intervention are at less risk of weight gain (overweight) than females in the control small group condition, that females in environmental schools are at less risk of weight gain (overweight) than females in the control environmental condition, and that females who receive both the small group and environmental intervention are at the lower risk of weight gain (overweight) than females who receive only the environmental or small group intervention or neither intervention.
- Conditions
- Overweight, Obesity
- Being tested
- Challenge! Small Group Intervention, Challenge! Environmental Intervention
- Keywords
- Overweight, Obesity, Prevention, Diet, Physical activity, Depression, Anxiety, Stages of change, Barriers, Perceptions, Environment, Eating Disorder, Self efficacy
- Medical subject headings
- Overweight, Obesity, Motor Activity, Depression, Anxiety Disorders, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Challenge! Small Group InterventionBehavioural
The Challenge! Small Group intervention consists of curriculum related to health behavior goal setting, healthy eating, and staying active, working out with Health Educators, and receiving a year-long membership to the YMCA.
Challenge! Environmental InterventionOther
The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.
| Study group | Role | What they receive |
|---|---|---|
| Challenge! Small Group Intervention only | Experimental | This group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA.
This group is in schools that were randomly assigned to NOT receive the Environmental Intervention. Receives: Behavioral: Challenge! Small Group Intervention |
| Challenge! Small Group and Environmental Intervention | Experimental | This group consists of participants who receive the Challenge! Small Group Intervention AND attend a school that is randomly assigned to receive an environmental intervention.
This group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA.
The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier. Receives: Behavioral: Challenge! Small Group Intervention; Other: Challenge! Environmental Intervention |
| Environmental Intervention Only | Experimental | This group consists of participants who do not receive the Challenge! Small Group Intervention but attend a school that is randomly assigned to receive an environmental intervention.
This group does not receive the Challenge! Small Group Intervention.
The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier. Receives: Other: Challenge! Environmental Intervention |
| Control Group | No intervention | This group does not receive the Challenge! Small Group intervention and is in a school that is randomly assigned to NOT have the Environmental Intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Body Mass Index Percentile for Age and Sex for adolescent females
Measured: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Secondary outcomes (1)
Change of Dietary Quality for adolescent females
Dietary quality will be assessed via the use of a Food Frequency Questionnaire.
Measured: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study startSep 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Johns Hopkins Bloomberg School of Public Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Maureen Black, University of Maryland, Baltimore
- Investigators
- Maureen M Black, PhD, Principal investigator, University of Maryland School of Medicine, Department of Pediatrics, Growth & Nutrition Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103269
- Sponsor's protocol ID
- HP-00040540
- Other IDs
- R01HD054727
- Acronym
- Challenge
- Status last verified
- Aug 2019
- First submitted
- 2 Apr 2010
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Trude ACB, Armstrong B, Kramer Fiala Machado A, Wickwire EM, Covington LB, Wang Y, Hager E, Black MM. Waking up to sleep's role in obesity and blood pressure among Black adolescent girls in low-income, US urban communities: A longitudinal analysis. Sleep Health. 2022 Apr;8(2):200-207. doi: 10.1016/j.sleh.2021.12.001. Epub 2022 Feb 11.
PubMed 35153168
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenge! in Baltimore City Middle Schools
- ClinicalTrials.gov ID
- NCT03103269
- Acronym / sponsor ID
- Challenge / HP-00040540
- Conditions
- Overweight, Obesity
- Keywords
- Overweight, Obesity, Prevention, Diet, Physical activity, Depression, Anxiety, Stages of change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Johns Hopkins Bloomberg School of Public Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Apr 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.
The prevalence of overweight among adolescents (BMI-for-age %tile over the 95th percentile) has more than tripled over the past 3 decades in the US. Overweight and physical inactivity disproportionately affect low- income, female, African American adolescents.
A prior health-promotion/ obesity-prevention program for adolescents developed and tested by our group (Challenge!) showed that adolescents who received the intervention were less likely to become overweight or obese over 2 years when compared to the control group. This intervention was administered one-on-one to adolescents in their homes or community by a college-aged mentor.
Schools are an ideal setting for interventions because the effect can be far-reaching and sustainable. School-based obesity-prevention interventions have thus far shown modest results.
The purpose of this study is to evaluate the impact of a multilevel intervention that includes both the Challenge program administered in a small group format after school using mentors and teachers and a school-wide environmental change on adolescent females' body composition, diet, and physical activity. The intervention is targeted to 6th and 7th grade female students. The small group intervention is conducted over 12 weeks and includes goal setting focusing on healthy diet and physical activity, along with membership and weekly trips to the YMCA. The environmental intervention includes a Health and Activity Committee (HAC), comprised of 8th grade female students (popular opinion leaders), school personnel, parents, and community members. The HAC develops school-wide health promotion messages and activities. Parents of participating 6th and 7th grade girls provide information on family variables. The hypotheses are that females who receive the small group or environmental intervention are at less risk of weight gain (overweight) than females in the control small group condition, that females in environmental schools are at less risk of weight gain (overweight) than females in the control environmental condition, and that females who receive both the small group and environmental intervention are at the lower risk of weight gain (overweight) than females who receive only the environmental or small group intervention or neither intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Challenge! Small Group Intervention only | Experimental | Behavioral: Challenge! Small Group InterventionThis group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA. This group is in schools that were randomly assigned to NOT receive the Environmental Intervention. |
| Challenge! Small Group and Environmental Intervention | Experimental | Behavioral: Challenge! Small Group Intervention, Other: Challenge! Environmental InterventionThis group consists of participants who receive the Challenge! Small Group Intervention AND attend a school that is randomly assigned to receive an environmental intervention. This group receives the Challenge! Small Group intervention consisting of curriculum related to health behavior goal setting, healthy eating, and staying active, works out with their Health Educators, and receives a year-long membership to the YMCA. The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier. |
| Environmental Intervention Only | Experimental | Other: Challenge! Environmental InterventionThis group consists of participants who do not receive the Challenge! Small Group Intervention but attend a school that is randomly assigned to receive an environmental intervention. This group does not receive the Challenge! Small Group Intervention. The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier. |
| Control Group | No intervention | –This group does not receive the Challenge! Small Group intervention and is in a school that is randomly assigned to NOT have the Environmental Intervention. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Female Adolescent
- Grades 6 or 7
- No health problems that would interfere with participation in physical education classes
- 8th grade female student
- Parent or legal guardian of any student in the school
Key exclusion criteria (8 listed)
- Male
- Outside of the grade range 6-7 at recruitment
- Participant will be excluded if they answer no to question 1 on the screening questionnaire (unable to read and understand questions written in English)
- Participant will be excluded if they answer yes to questions 2 or 3 on screening form (fails health screening due to medical condition preventing them from engaging in physical activity)
- Inability to speak or read English
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 |
|---|---|---|
| Challenge! Small Group InterventionThe Challenge! Small Group intervention consists of curriculum related to health behavior goal setting, healthy eating, and staying active, working out with Health Educators, and receiving a year-long membership to the YMCA. | Behavioural | Challenge! Small Group Intervention only, Challenge! Small Group and Environmental Intervention |
| Challenge! Environmental InterventionThe environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier. | Other | Challenge! Small Group and Environmental Intervention, Environmental Intervention Only |
Primary outcome
Change of Body Mass Index Percentile for Age and Sex for adolescent females
Time frame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
1 secondary outcome
Change of Dietary Quality for adolescent females
Time frame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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 Aug 2019.
- Derived from this study: PubMed 35153168Trude ACB, Armstrong B, Kramer Fiala Machado A, Wickwire EM, Covington LB, Wang Y, Hager E, Black MM. Waking up to sleep's role in obesity and blood pressure among Black adolescent girls in low-income, US urban communities: A longitudinal analysis. Sleep Health. 2022 Apr;8(2):200-207. doi: 10.1016/j.sleh.2021.12.001. Epub 2022 Feb 11.
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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.
Maureen M Black, PhD principal investigator
University of Maryland School of Medicine, Department of Pediatrics, Growth & Nutrition Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Challenge! Small Group Intervention and Challenge! Environmental Intervention in people with Overweight and Obesity, run by University of Maryland, Baltimore 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 10 inclusion and 8 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 Aug 2019. 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 of Body Mass Index Percentile for Age and Sex for adolescent females (time frame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up). 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 NCT03103269, 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 16 Aug 2019; AzTrials last refreshed its copy on 29 Oct 2026.