Ideas Moving Parents and Adolescents to Change Together (IMPACT)

NCT01514279 | Completed Results DMC

• 2 other identifiers: IMPACT-1-5U01HL103622-025U01HL103622-02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obese

Keywords

Overweight; Obese; Over Nutrition; Nutrition Disorders; Body weight; Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Dietary Intake- Calories Per Day

  Baseline, 12 mos, 24 mos and 36 mos

• Blood Pressure

  Baseline, 12 mos, 24 mos and 36 mos

• Physical Activity

  [Baseline, 12 mos, 24 mos and 36 mos]

• Sleep

  [Baseline, 12 mos, 24 mos and 36 mos]

• Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol

  Baseline, 12 mos, 24 mos and 36 mos

Study Arms (3)

HealthyCHANGE

EXPERIMENTAL

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

Behavioral: HealthyCHANGE

SystemCHANGE

EXPERIMENTAL

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

Tools4CHANGE

NO INTERVENTION

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.

Interventions

HealthyCHANGE BEHAVIORAL

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.

HealthyCHANGE

SystemCHANGE BEHAVIORAL

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.

SystemCHANGE

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (6)

• 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.

  PMID: 24008055 BACKGROUND

• Schuler BR, Gardenhire RA, Jones SD, Spilsbury JC, Moore SM, Borawski EA. Exploring the Association Between Trauma, Instability, and Youth Cardiometabolic Health Outcomes Over Three Years. J Adolesc Health. 2024 Feb;74(2):301-311. doi: 10.1016/j.jadohealth.2023.08.049. Epub 2023 Oct 15.

  PMID: 37843478 DERIVED

• 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.

  PMID: 32909523 DERIVED

• 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.

  PMID: 32153951 DERIVED

• 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.

  PMID: 31138278 DERIVED

• 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.

  PMID: 31126971 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Nutrition Disorders; Body Weight; Signs and Symptoms

Condition Hierarchy (Ancestors)

Overnutrition; Nutritional and Metabolic Diseases; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Elaine Borawski, PhD
• Organization: School of Medicine, Case Western Reserve University

exb11@case.edu

216)368-1024

Study Officials

• Elaine A Borawski, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Shirley M Moore, RN, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Angela Bowen Williamson Professor of Community Nutrition, Director, Prevention Research Center for Healthy Neighborhoods

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 23, 2012
• Study Start: February 1, 2011
• Primary Completion: January 21, 2017
• Study Completion: January 31, 2017
• Last Updated: August 25, 2020
• Results First Posted: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)