NCT03103269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
789

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
Last Updated

August 16, 2019

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

April 2, 2010

Last Update Submit

August 14, 2019

Conditions

OverweightObesity

Keywords

OverweightObesityPreventionDietPhysical activityDepressionAnxietyStages of changeBarriersPerceptionsEnvironmentEating DisorderSelf efficacy

Outcome Measures

Primary Outcomes (1)

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

    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

    Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up

Study Arms (4)

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.

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.

Behavioral: Challenge! Small Group InterventionOther: 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.

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.

Interventions

Challenge! Small Group InterventionBEHAVIORAL

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! Small Group Intervention onlyChallenge! Small Group and Environmental Intervention
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.

Challenge! Small Group and Environmental InterventionEnvironmental Intervention Only

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • th 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore City Public Schools

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

  • 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.

    PMID: 35153168DERIVED

MeSH Terms

Conditions

OverweightObesityMotor ActivityDepressionAnxiety DisordersFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBehavioral SymptomsMental DisordersSigns and Symptoms, Digestive

Study Officials

  • Maureen M Black, PhD

    University of Maryland School of Medicine, Department of Pediatrics, Growth & Nutrition Division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2010

First Posted

April 6, 2017

Study Start

September 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 16, 2019

Record last verified: 2019-08

Locations

US(1)