Ideas Moving Parents and Adolescents to Change Together (IMPACT)

Overweight Clinical Trial

— 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514279
• Other study ID #: IMPACT-1-5U01HL103622-02
• Secondary ID: 5U01HL103622-02
• Status: Completed
• Phase: N/A
• Start date: February 1, 2011
• Est. completion date: January 31, 2017

Study information

• Verified date: August 2020
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: January 31, 2017
• Est. primary completion date: January 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obese
• Overweight

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slope of Body Mass Index (BMI)	BMI slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without BMI values post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	Baseline, 12 mos, 24 mos and 36 mos
Secondary	Dietary Intake- Calories Per Day	Annualized change in calories per day.; Dietary intake slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	Baseline, 12 mos, 24 mos and 36 mos
Secondary	Blood Pressure	Annualized change in blood pressure measures using the slope of 3 year trajectory.; Blood pressure slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood pressure readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	Baseline, 12 mos, 24 mos and 36 mos
Secondary	Physical Activity	Annualized change in physical activity measures of moderate to vigorous minutes per day and bed rest/sedentary minutes per day as measured by accelerometer.; Physical activity slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without accelerometer readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	[Baseline, 12 mos, 24 mos and 36 mos]
Secondary	Sleep	The results reflect the annualized change in adolescent sleep wake scale and pediatric daytime sleepiness scale. The items of the adolescent sleep wake scale are recoded to have a minimum of 0 and maximum value of 5, in which a higher scores for both the individual items and the overall sum score indicate a better outcome. The items of the pediatric daytime sleepiness are recoded to have a minimum of 0 and maximum value of 4, in which a lower score for both the individual items and the overall sum score indicates a better outcome.; Sleep slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without post-baseline measures. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	[Baseline, 12 mos, 24 mos and 36 mos]
Secondary	Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol	Annualized change in various cardiometabolic factor measures over 3 years.; Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.; Change in the slopes of fasting glucose, HDL cholesterol, LDL cholesterol, and total cholesterol over 3 years reported.	Baseline, 12 mos, 24 mos and 36 mos
Secondary	Body Composition- BMI Percentile	The annualized change in body composition measures over 3 years.; Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.; Change in slope of BMI percentile over time reported.	Baseline, 12 mos, 24 mos and 36 mos
Secondary	Fitness	The annualized change in pacer laps completed during PACER test over 3 years.; PACER test slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without PACER test measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	Baseline, 12 mos, 24 mos and 36 mos
Secondary	Quality of Life- Perceived Stress	The annualized change in perceived stress over 3 years. Participants are asked to rate individual scale items on their perception of how often they feel specific stressors on a scale from 0 (never) to 4 (very often). Individual scale items are summed for a total score. Higher scores indicate higher perceived frequency of stressors, therefore higher perceived stress. Outcomes are reported as the mean of the slope estimates for total perceived stress score over 3 years (from baseline to 36 months).; The perceived stress slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without stress scores post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	[Baseline, 12 mos, 24 mos and 36 mos]
Secondary	Dietary Intake- Percent Calories From Fat	The annualized change of percent of calories from fat over 3 years.; Percent calories from fat slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	Baseline, 12 months, 24 months, 36 months
Secondary	Dietary Intake- Fruit and Vegetable Servings	The annualized change in the number of fruit and vegetable servings per day over 3 years.; Serving slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	Baseline, 12 months, 24 months, 36 months
Secondary	Dietary Intake- Sodium	The annualized change in sodium intake (mg) per day over 3 years.; Sodium intake slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.	Baseline, 12 months, 24 months, 36 months
Secondary	Cardiometabolic Factors- Hemoglobin A1c	Annualized change in various cardiometabolic factor measures over 3 years.; Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.; Change in the slope of glycated Hemoglobin A1c over 3 years reported.	[Baseline, 12 mos, 24 mos, 36 mos]
Secondary	Cardiometabolic Factors- High-sensitivity C-reactive Protein	Annualized change in various cardiometabolic factor measures over 3 years.; Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.; Change in the slope of high-sensitivity C-reactive protein over 3 years reported.	[Baseline, 12 mos, 24 mos, 36 mos]
Secondary	Cardiometabolic Factors- Insulin	Annualized change in various cardiometabolic factor measures over 3 years.; Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.; Change in the slope of insulin over 3 years reported.	[Baseline, 12 mos, 24 mos, 36 mos]
Secondary	Cardiometabolic Factors- HOMA-IR	Annualized change in various cardiometabolic factor measures over 3 years.; Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.; Change in the slope of HOMA-IR over 3 years reported.	[Baseline, 12 mos, 24 mos, 36 mos]
Secondary	Body Composition- Waist-to-height Ratio	The annualized change in body composition measures over 3 years.; Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.; Change in slope of waist-to-height ratio over time reported. The weight-to-heigh ratio compares the child's waist circumference (cm) to their height (cm).	[Baseline, 12 mos, 24 mos, 36 mos]
Secondary	Body Composition- Waist Circumference	The annualized change in body composition measures over 3 years.; Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.; Change in slope of waist circumference (cm) over time reported.	[Baseline, 12 mos, 24 mos, 36 mos]
Secondary	Body Composition- Percent Body Fat	The annualized change in body composition measures over 3 years.; Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.; Change in slope of body fat percentage over time reported. Body fat percentage calculated using Stevens equation.	[Baseline, 12 mos, 24 mos, 36 mos]