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Ideas Moving Parents and Adolescents to Change Together (IMPACT)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Elaine Borawski, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01514279
First received: December 20, 2011
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case Western Reserve/Cleveland's project is entitled "Targeting Obesity and Blood Pressure in Urban Youth". The site name is IMPACT (Ideas Moving Parents and Adolescents to Change Together).

The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only intervention (Tools4Change). In addition the study assesses the potential additional impact of a school-community based intervention on outcomes.

The project has two phases: a formative phase (including focus groups and a pilot) and the main trial. The main trial will take place over approximately four years.


Condition Intervention
Overweight
Obese
 Behavioral: HealthyCHANGE
Behavioral: SystemCHANGE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Obesity and Blood Pressure in Urban Youth(Consortium Title: Childhood Obesity Prevention and Treatment Research [COPTR] and Site Project Name IMPACT (Ideas Moving Parents and Adolescents to Change Together).

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Slope of Body Mass Index (BMI) [ Time Frame: [Baseline, 12 mos, 24 mos and 36 mos] ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dietary Intake [ Time Frame: [Baseline, 12 mos, 24 mos and 36 mos] ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: [Baseline, 12 mos, 24 mos and 36 mos] ] [ Designated as safety issue: No ]
  • Physical Activity [ Time Frame: [Baseline, 12 mos, 24 mos and 36 mos] ] [ Designated as safety issue: No ]
  • Sleep [ Time Frame: [Baseline, 12 mos, 24 mos and 36 mos] ] [ Designated as safety issue: No ]
  • Cardiovascular Risk Factors [ Time Frame: [Baseline, 8 mos, 12 mos, 24 mos and 36 mos] ] [ Designated as safety issue: No ]
  • Body Composition [ Time Frame: [Baseline, 8 mos, 12 mos, 24 mos and 36 mos] ] [ Designated as safety issue: No ]
  • Fitness [ Time Frame: [Baseline, 8 mos, 12 mos, 24 mos and 36 mos] ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: [Baseline, 8 mos, 12 mos, 24 mos and 36 mos] ] [ Designated as safety issue: No ]
  • DNA [ Time Frame: [1 Day] ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: February 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HealthyCHANGE
Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.
 Behavioral: HealthyCHANGE

Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
Experimental: SystemCHANGE
Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines
 Behavioral: SystemCHANGE

Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
No Intervention: Tools4CHANGE
In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.

Detailed Description:

The IMPACT trial will involve a 3-arm randomized controlled trial of three behavioral and educational interventions: (1) HealthyCHANGE, a behavioral approach focusing on building skills and increasing intrinsic motivation (based on cognitive-behavioral theory with motivational interviewing components); (2) SystemCHANGE, an innovative behavioral approach focusing on system re-design of the family environment and daily routines (based on social-ecological and personal process improvement theories); and (3) education-only (representing usual care, called Tools4CHANGE).

In the main trial, approximately half of the children will also be in schools that take part in the We Run This City (WRTC)Marathon program, a school-based fitness program administered by the YMCA, and half will be in schools that do not take part in the WRTC program.

This study will assess the impact of the interventions on the main trial's (1) primary outcome, Change in Body Mass Index (BMI). (2) secondary outcomes including diet, physical activity, sedentary behavior, sleep, blood pressure, cardiovascular risk, body composition, fitness, and quality of life (3) mediators including : child's self-efficacy, social support, motivation, family problem solving ability, systems thinking, and self-regulation;(4) moderators including: socioeconomic status, demographic factors, environmental factors, personal and psychosocial characteristics of child and parent.

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Students entering the 6th grade who are found at the standard school screenings to be overweight or obese
  • (BMI 85th- 94th percentile or > 95th percentile for age/sex respectively)

Exclusion Criteria:

  • Taking medications that alter appetite or weight (e.g. glucocorticoids, metformin, insulin, Risperidone (Risperdal), Olanzapine (Zyprexa), Clozapine(Clozaril), Quetiapine (Seroquel), Ziprasidone (Geodon), Carbamazepine (Tegretol), Valproic acid (Depakote/Depakene/Depacon), Aripiprazole (Abilify), Orlistat (Xenical), Sibutramine (Meridia), Phentermine, Diethylproprion (Tenuate), Topirimate (Topamax), glitazones (thiazolidinediones)
  • Inability to understand English
  • Stage 2 hypertension or stage 1 hypertension with end organ damage (left ventricular hypertrophy, microalbuminuria)
  • Severe behavioral problems that preclude group participation (as reported by parent/guardian)
  • Child involvement in another weight management program
  • Family expectation to move from the region within 1 year
  • The presence of a known medical condition that itself causes obesity (e.g., Prader-Willi syndrome) or interfere with HbA1C ( sickle cell disease)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514279

Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Leona Cuttler, MD Case Western Reserve University
Principal Investigator: Elaine A Borawski, PhD Case Western Reserve University
Principal Investigator: Shirley M Moore, RN, PhD Case Western Reserve University
  More Information

No publications provided

Responsible Party: Elaine Borawski, Angela Bowen Williamson Professor of Community Nutrition, Director, Prevention Research Center for Healthy Neighborhoods, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01514279     History of Changes
Other Study ID Numbers: IMPACT-1-5U01HL103622-02, 5U01HL103622-02
Study First Received: December 20, 2011
Last Updated: March 25, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Case Western Reserve University:
Overweight
Obese
Over Nutrition
 Nutrition Disorders
Body weight
Signs and Symptoms

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013