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Challenge! Adolescent Obesity Prevention (Challenge)

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Challenge! Small Group Intervention
Challenge! Environmental Intervention
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Overweight, Obesity, Prevention, Diet, Physical activity, Depression, Anxiety, Stages of change, Barriers, Perceptions, Environment, Eating Disorder, Self efficacy

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baltimore City Public Schools

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Challenge! Small Group Intervention only

Challenge! Small Group and Environmental Intervention

Environmental Intervention Only

Control Group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change of Body Mass Index Percentile for Age and Sex for adolescent females

Secondary Outcome Measures

Change of Dietary Quality for adolescent females
Dietary quality will be assessed via the use of a Food Frequency Questionnaire.

Full Information

First Posted
April 2, 2010
Last Updated
August 14, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
Robert Wood Johnson Foundation, Johns Hopkins Bloomberg School of Public Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03103269
Brief Title
Challenge! Adolescent Obesity Prevention
Acronym
Challenge
Official Title
Challenge! in Baltimore City Middle Schools
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Robert Wood Johnson Foundation, Johns Hopkins Bloomberg School of Public Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
Overweight, Obesity, Prevention, Diet, Physical activity, Depression, Anxiety, Stages of change, Barriers, Perceptions, Environment, Eating Disorder, Self efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
789 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Challenge! Small Group Intervention only
Arm Type
Experimental
Arm Description
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.
Arm Title
Challenge! Small Group and Environmental Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Environmental Intervention Only
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Challenge! Small Group Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Challenge! Environmental Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change of Dietary Quality for adolescent females
Description
Dietary quality will be assessed via the use of a Food Frequency Questionnaire.
Time Frame
Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen M Black, PhD
Organizational Affiliation
University of Maryland School of Medicine, Department of Pediatrics, Growth & Nutrition Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore City Public Schools
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35153168
Citation
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.
Results Reference
derived

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Challenge! Adolescent Obesity Prevention

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