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Challenge! Adolescent Obesity Prevention (Challenge)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103269
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Robert Wood Johnson Foundation
Johns Hopkins Bloomberg School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Maureen Black, University of Maryland, Baltimore

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Challenge! Small Group Intervention Other: Challenge! Environmental Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 789 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Challenge! in Baltimore City Middle Schools
Study Start Date : September 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: Challenge! Small Group Intervention only

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.

Behavioral: Challenge! Small Group Intervention
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.

Experimental: Challenge! Small Group and Environmental Intervention

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.

Behavioral: Challenge! Small Group Intervention
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.

Other: Challenge! Environmental 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.

Experimental: Environmental Intervention Only

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.

Other: Challenge! Environmental 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.

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change of Dietary Quality for adolescent females [ Time Frame: Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up ]
    Dietary quality will be assessed via the use of a Food Frequency Questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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:

  • 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103269


Locations
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United States, Maryland
Baltimore City Public Schools
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Robert Wood Johnson Foundation
Johns Hopkins Bloomberg School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Maureen M Black, PhD University of Maryland School of Medicine, Department of Pediatrics, Growth & Nutrition Division
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Responsible Party: Maureen Black, Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT03103269    
Other Study ID Numbers: HP-00040540
R01HD054727 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Keywords provided by Maureen Black, University of Maryland, Baltimore:
Overweight
Obesity
Prevention
Diet
Physical activity
Depression
Anxiety
Stages of change
Barriers
Perceptions
Environment
Eating Disorder
Self efficacy
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight