School Nurse Intervention and After School Exercise Program for Overweight Teens

NCT01463124 | Completed Phase 2 DMC

• 1 other identifier: R21HL110208
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescent overweight and obesity have increased dramatically in the past several decades. High schools are well-positioned to deliver weight loss treatment to overweight and obese adolescents, as they have the facilities and staff to deliver a physical activity program, school nurses with the skills to provide counseling, and are easily accessible by adolescents. This exploratory study will test the feasibility and ability of a school-based intervention, consisting of school nurse counseling and a school-based exercise program, to reduce BMI and improve dietary quality, physical activity, and sedentary behaviors in overweight and obese adolescents. If effective, this could prove to be a cost-effective and relatively easy intervention to disseminate widely for significant public health impact.

Conditions

Overweight; Obesity

Keywords

School Nurse; Overweight; Obesity; Counseling; Intervention; Exercise

Outcome Measures

Primary Outcomes (2)

• Body Mass Index (BMI)

  Lookin Good Feelin Good (LGFG) program participants will achieve greater reduction in BMI z-scores than Information attention control (IC) participants after one academic year (8 months) of intervention

  One academic year (8 months)

• Participation in exercise program

  LGFG participants will report greater than 90% adherence to intervention protocol by school nurses on Patient Exit Interview (PEI) checklists following each of the 6 visits and will attend at least 75% of the exercise sessions.

  One academic year (8 months)

Secondary Outcomes (3)

• Self-management

  One academic year (8 months)

• Physiologic outcomes

  One academic year (8 months)

• Psychosocial outcomes

  One academic year (8 months)

Study Arms (2)

Lookin' Good Feelin' Good

EXPERIMENTAL

Six 30-minute individual student-centered counseling sessions delivered by school nurses during the first two months followed by weekly weigh-ins and monthly visits over the subsequent 6 months, plus an exercise program in the school 3 times a week for the full eight months of the intervention.

Behavioral: Lookin' Good Feelin' Good

Information attention-control

ACTIVE COMPARATOR

Six individual sessions with school nurse over the first two months followed by monthly visits over the remaining 6 months to check weight and behavior changes and provide a series of pamphlets on weight and weight management.

Behavioral: Information attention-control

Interventions

Lookin' Good Feelin' Good BEHAVIORAL

Six 30-minute individual student-centered counseling sessions delivered by school nurses during the first two months followed by weekly weigh-ins and monthly visits over the subsequent 6 months, plus an exercise program in the school 3 times a week for the full eight months of the intervention.

Lookin' Good Feelin' Good

Information attention-control BEHAVIORAL

Six individual sessions with school nurse over the first two months followed by monthly visits over the remaining 6 months to check weight and behavior changes and provide a series of pamphlets on weight and weight management.

Information attention-control

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• enrolled in grades 9 - 12
• BMI \> 85th percentile for age/sex
• able to understand and participate in the study
• able and willing to provide informed assent (adolescent) and consent (parent)
• English-speaking with at least one English-speaking parent

You may not qualify if:

• planning to move out of the area within the next 8 months
• medical condition that precludes adherence to study dietary recommendations (e.g., pregnancy, Crohn's disease, ulcerative colitis)
• diagnosis of a serious psychiatric illness (e.g., psychiatric hospitalization, eating disorder, suicidal) within the past 5 years
• genetic or endocrine causes of obesity (e.g., pradi Willi, Cushing's Syndrome)
• developmental delay that would prevent participation in the intervention or measurements
• prescribed medications associated with weight gain (e.g.,oral steroids)
• morbidly obese, defined as weighing \> 300 pounds

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Lori Pbert, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 1, 2011
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

US (1)