Clinical trial NCT01514279: Ideas Moving Parents and Adolescents to Change Together (IMPACT)
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Keywords: Overweight
Obese
Over Nutrition
Nutrition Disorders
Body weight
Signs and Symptoms
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-01-23
Enrollment: 360
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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)

Primary outcomes:
measure: Slope of Body Mass Index (BMI)
timeFrame: Baseline, 12 mos, 24 mos and 36 mos
Secondary outcomes:
measure: Dietary Intake- Calories Per Day
timeFrame: Baseline, 12 mos, 24 mos and 36 mos
measure: Blood Pressure
timeFrame: Baseline, 12 mos, 24 mos and 36 mos
measure: Physical Activity
timeFrame: [Baseline, 12 mos, 24 mos and 36 mos]
measure: Sleep
timeFrame: [Baseline, 12 mos, 24 mos and 36 mos]
measure: Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol
timeFrame: Baseline, 12 mos, 24 mos and 36 mos
measure: Body Composition- BMI Percentile
timeFrame: Baseline, 12 mos, 24 mos and 36 mos
measure: Fitness
timeFrame: Baseline, 12 mos, 24 mos and 36 mos
measure: Quality of Life- Perceived Stress
timeFrame: [Baseline, 12 mos, 24 mos and 36 mos]
measure: Dietary Intake- Percent Calories From Fat
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Dietary Intake- Fruit and Vegetable Servings
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Dietary Intake- Sodium
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Cardiometabolic Factors- Hemoglobin A1c
timeFrame: [Baseline, 12 mos, 24 mos, 36 mos]
measure: Cardiometabolic Factors- High-sensitivity C-reactive Protein
timeFrame: [Baseline, 12 mos, 24 mos, 36 mos]
measure: Cardiometabolic Factors- Insulin
timeFrame: [Baseline, 12 mos, 24 mos, 36 mos]
measure: Cardiometabolic Factors- HOMA-IR
timeFrame: [Baseline, 12 mos, 24 mos, 36 mos]
measure: Body Composition- Waist-to-height Ratio
timeFrame: [Baseline, 12 mos, 24 mos, 36 mos]
measure: Body Composition- Waist Circumference
timeFrame: [Baseline, 12 mos, 24 mos, 36 mos]
measure: Body Composition- Percent Body Fat
timeFrame: [Baseline, 12 mos, 24 mos, 36 mos]
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Elaine A Borawski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Shirley M Moore, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moore SM, Borawski EA, Cuttler L, Ievers-Landis CE, Love TE. IMPACT: a multi-level family and school intervention targeting obesity in urban youth. Contemp Clin Trials. 2013 Nov;36(2):574-86. doi: 10.1016/j.cct.2013.08.009. Epub 2013 Sep 2.
citation: JaKa MM, Wood C, Veblen-Mortenson S, Moore SM, Matheson D, Stevens J, Atkins L, Michie S, Adegbite-Adeniyi C, Olayinka O, Po'e EK, Kelly AM, Nicastro H, Bangdiwala SI, Barkin SL, Pratt C, Robinson TN, Sherwood NE. Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions. West J Nurs Res. 2021 May;43(5):468-477. doi: 10.1177/0193945920954782. Epub 2020 Sep 10.
citation: Truesdale KP, Matheson DM, JaKa MM, McAleer S, Sommer EC, Pratt CA. Baseline diet quality of predominantly minority children and adolescents from households characterized by low socioeconomic status in the Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. BMC Nutr. 2019 Sep 9;5:38. doi: 10.1186/s40795-019-0302-y. eCollection 2019.
citation: Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0.
citation: Moore SM, Borawski EA, Love TE, Jones S, Casey T, McAleer S, Thomas C, Adegbite-Adeniyi C, Uli NK, Hardin HK, Trapl ES, Plow M, Stevens J, Truesdale KP, Pratt CA, Long M, Nevar A. Two Family Interventions to Reduce BMI in Low-Income Urban Youth: A Randomized Trial. Pediatrics. 2019 Jun;143(6):e20182185. doi: 10.1542/peds.2018-2185.