OverweightIMPACTNCT01514279
Ideas Moving Parents and Adolescents to Change Together (IMPACT)
A study testing HealthyCHANGE and SystemCHANGE in people with Overweight and Obese, run by Case Western Reserve University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- HealthyCHANGE and SystemCHANGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2011to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
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).
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.
Read the 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.
- Conditions
- Overweight, Obese
- Being tested
- HealthyCHANGE, SystemCHANGE
- Keywords
- Overweight, Obese, Over Nutrition, Nutrition Disorders, Body weight, Signs and Symptoms
- Medical subject headings
- Overweight, Obesity, Nutrition Disorders, Body Weight, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthyCHANGEBehavioural
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.
SystemCHANGEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HealthyCHANGE | Experimental | Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 mos, 24 mos and 36 mos
Secondary outcomes (18)
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.
Measured: Baseline, 12 mos, 24 mos and 36 mos
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.
Measured: Baseline, 12 mos, 24 mos and 36 mos
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.
Measured: [Baseline, 12 mos, 24 mos and 36 mos]
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.
Measured: [Baseline, 12 mos, 24 mos and 36 mos]
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.
Measured: Baseline, 12 mos, 24 mos and 36 mos
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.
Measured: Baseline, 12 mos, 24 mos and 36 mos
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.
Measured: Baseline, 12 mos, 24 mos and 36 mos
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.
Measured: [Baseline, 12 mos, 24 mos and 36 mos]
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.
Measured: Baseline, 12 months, 24 months, 36 months
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.
Measured: Baseline, 12 months, 24 months, 36 months
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.
Measured: Baseline, 12 months, 24 months, 36 months
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.
Measured: [Baseline, 12 mos, 24 mos, 36 mos]
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.
Measured: [Baseline, 12 mos, 24 mos, 36 mos]
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.
Measured: [Baseline, 12 mos, 24 mos, 36 mos]
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.
Measured: [Baseline, 12 mos, 24 mos, 36 mos]
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).
Measured: [Baseline, 12 mos, 24 mos, 36 mos]
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.
Measured: [Baseline, 12 mos, 24 mos, 36 mos]
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.
Measured: [Baseline, 12 mos, 24 mos, 36 mos]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study start1 Feb 2011
- Primary completion21 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Elaine Borawski, Case Western Reserve University
- Investigators
- Elaine A Borawski, PhD, Principal investigator, Case Western Reserve UniversityShirley M Moore, RN, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514279
- Sponsor's protocol ID
- IMPACT-1-5U01HL103622-02
- Other IDs
- 5U01HL103622-02
- Acronym
- IMPACT
- Status last verified
- Aug 2020
- First submitted
- 20 Dec 2011
- Last updated
- 25 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Conducted in conjunction with the Research Coordinating Unit (UNC Chapel Hill) of the COPTR Consortium.
Publications
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.
PubMed 24008055Schuler 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.
PubMed 37843478JaKa 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.
PubMed 32909523Truesdale 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.
PubMed 32153951Cui 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.
PubMed 31138278Moore 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.
PubMed 31126971
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01514279
- Acronym / sponsor ID
- IMPACT / IMPACT-1-5U01HL103622-02
- Conditions
- Overweight, Obese
- Keywords
- Overweight, Obese, Over Nutrition, Nutrition Disorders, Body weight, Signs and Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 21 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Posted 25 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HealthyCHANGE | Experimental | Behavioral: HealthyCHANGECognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. |
| SystemCHANGE | Experimental | Behavioral: SystemCHANGEIntervention (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 |
| 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. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HealthyCHANGECognitive 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. | Behavioural | HealthyCHANGE |
| SystemCHANGEIntervention (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. | Behavioural | SystemCHANGE |
Primary outcome
Slope of Body Mass Index (BMI)
Time frame: Baseline, 12 mos, 24 mos and 36 mos
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.
18 secondary outcomes
Dietary Intake- Calories Per Day
Time frame: Baseline, 12 mos, 24 mos and 36 mos
Blood Pressure
Time frame: Baseline, 12 mos, 24 mos and 36 mos
Physical Activity
Time frame: [Baseline, 12 mos, 24 mos and 36 mos]
Sleep
Time frame: [Baseline, 12 mos, 24 mos and 36 mos]
Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol
Time frame: Baseline, 12 mos, 24 mos and 36 mos
Body Composition- BMI Percentile
Time frame: Baseline, 12 mos, 24 mos and 36 mos
Fitness
Time frame: Baseline, 12 mos, 24 mos and 36 mos
Quality of Life- Perceived Stress
Time frame: [Baseline, 12 mos, 24 mos and 36 mos]
Dietary Intake- Percent Calories From Fat
Time frame: Baseline, 12 months, 24 months, 36 months
Dietary Intake- Fruit and Vegetable Servings
Time frame: Baseline, 12 months, 24 months, 36 months
Dietary Intake- Sodium
Time frame: Baseline, 12 months, 24 months, 36 months
Cardiometabolic Factors- Hemoglobin A1c
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
Cardiometabolic Factors- High-sensitivity C-reactive Protein
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
Cardiometabolic Factors- Insulin
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
Cardiometabolic Factors- HOMA-IR
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
Body Composition- Waist-to-height Ratio
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
Body Composition- Waist Circumference
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
Body Composition- Percent Body Fat
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24008055Moore 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.
- Derived from this study: PubMed 37843478Schuler 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.
- Derived from this study: PubMed 32909523JaKa 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.
- Derived from this study: PubMed 32153951Truesdale 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.
- Derived from this study: PubMed 31138278Cui 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.
- Derived from this study: PubMed 31126971Moore 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.
- Individual participant dataSharing planned: Yes. Conducted in conjunction with the Research Coordinating Unit (UNC Chapel Hill) of the COPTR Consortium.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine A Borawski, PhD principal investigator
Case Western Reserve University
Shirley M Moore, RN, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthyCHANGE and SystemCHANGE in people with Overweight and Obese, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slope of Body Mass Index (BMI) (time frame: Baseline, 12 mos, 24 mos and 36 mos). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01514279, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.