AzTrials
AzTrials

Congenital Heart DiseaseSHTNCT02980393

Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects

A study testing Lifestyle intervention in people with Congenital Heart Disease and Pediatric Obesity, run by Kambiz Norozi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is to assess whether a lifestyle intervention with diet, exercise and counselling in young patients will have a positive influence on their weight and overall well-being. Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Congenital Heart Disease, Pediatric Obesity
What is being tested?
Lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
May 2012to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

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 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • overweight or obese (BMI> 85%) patients
  • between 7-17 years of age
  • operated or non-operated congenital heart disease
  • reside in Southwestern Ontario

Who cannot join

  • inability to comply with research testing or intervention components due to mental and/or physical disabilities, medications or comorbidities affecting weight or metabolic condition
  • involvement in any concurrent lifestyle intervention program

About this study

Official title: The Impact of a Structured Lifestyle Intervention on Body Composition and Exercise Capacity in Overweight Children With Operated Heart Defects

This study is to assess whether a lifestyle intervention with diet, exercise and counselling in young patients will have a positive influence on their weight and overall well-being. This study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart disease, and have been identified being overweight or obese. A total of 40 individuals will participate in this study. The study duration will last for 1 year.

Being tested
Lifestyle intervention
Keywords
congenital heart disease, smart mobile technology, children, adolescents, lifestyle counselling, nutrition, physical activity
Medical subject headings
Heart Defects, Congenital, Pediatric Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionBehavioural

    The structured lifestyle intervention involves alternating weekly phone calls with two health coaches: a registered dietitian and a fitness specialist. A total of 50 phone calls (25 nutrition-related and 25 physical activity-related) are delivered over the one-year study. After six months in the program, participants are introduced to supporting program-specific software that they can access online, as an additional way to interact with the program, set goals, and record their progress. Client and family-centred nutrition and physical activity counselling includes an initial and regular behavioural assessment, and subsequent conversations (i.e., phone calls) using motivational interviewing techniques intended to increase knowledge or skills, and improve behaviours.

Study groups in NCT02980393
Study groupRoleWhat they receive
Lifestyle interventionExperimentalParticipants are guided by a fitness specialist who will help the participants to incorporate physical activity into their daily life. Based on the cardiologist assessment, an individual home-based exercise program will be developed. Participants are also guided and advised on nutrition with emphasis on low fat content and increased fiber. The nutrition counseling will focus on sustainable changes and will help participants to make healthy food choices.
Receives: Behavioral: Lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Baseline Body Mass Index (BMI) at 1 year

    BMI is derived from body mass divided by the square of the body height

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  2. Change in Baseline Fat Mass at 1 year

    Dual energy x-ray absorptiometry (DEXA) will measure fat mass.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  3. Change in Baseline Lean Mass at 1 year

    Dual energy x-ray absorptiometry (DEXA) will measure lean mass.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  4. Change in Baseline Percent Fat at 1 year

    Dual energy x-ray absorptiometry (DEXA) will measure percent fat.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  5. Change in Baseline Percent Android Fat at 1 year

    Dual energy x-ray absorptiometry (DEXA) will measure percent android fat.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  6. Change in Baseline Visceral Adipose Tissue at 1 year

    Dual energy x-ray absorptiometry (DEXA) will measure visceral adipose tissue.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  7. Change in Baseline Bone Mineral Content at 1 year

    Dual energy x-ray absorptiometry (DEXA) will measure bone mineral content.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  8. Change in Baseline Maximum Oxygen Consumption at 1 year

    Maximal exercise graded treadmill test will determine maximal oxygen consumption.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

Secondary outcomes (15)

  1. Change in Baseline Average Caloric Intake at 1 year

    Average caloric intake is estimated from three-day food records.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  2. Change in Baseline Self-Report Physical Activity Levels at 1 year

    Physical activity levels will also be measured by the Physical Activity Questionnaire for Older Children

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  3. Change in Baseline Physical Activity Levels at 1 year

    Physical activity levels will be measured from accelerometers

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  4. Change in Baseline Quality of Life at 1 year

    Pediatric Quality of Life Inventory Generic Core Scales

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  5. Change in Baseline Muscle function at 1 year

    Leonardo Mechanograph® Ground Reaction Force Plate will assess jumping height.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  6. Change in Baseline Electrocardiographic measurement at 1 year

    Electrocardiogram

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  7. Change in Baseline Transthoracic echocardiographic measurement at 1 year

    Echo-cardiogram will be employed.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  8. Change in Baseline Endothelial vasodilator function at 1 year

    Peripheral arterial tonometry will assess endothelial vasodilator function.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  9. Change in Baseline Lipid Profile at 1 year

    Blood is drawn from patients who have been asked to fast for at least 10 hours.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  10. Change in Baseline Electrolytes at 1 year

    Blood is drawn from patients who have been asked to fast for at least 10 hours.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  11. Change in Baseline Creatinine at 1 year

    Blood is drawn from patients who have been asked to fast for at least 10 hours.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  12. Change in Baseline Urea at 1 year

    Blood is drawn from patients who have been asked to fast for at least 10 hours.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  13. Change in Baseline Fasting Glucose at 1 year

    Blood is drawn from patients who have been asked to fast for at least 10 hours.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  14. Change in Baseline Serum Insulin at 1 year

    Blood is drawn from patients who have been asked to fast for at least 10 hours.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

  15. Change in Baseline Adiponectin at 1 year

    Blood is drawn from patients who have been asked to fast for at least 10 hours.

    Measured: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2016 (estimated)
  2. Study startMay 2012
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02980393
Sponsor's protocol ID
102392
Other IDs
18843
Acronym
SHT
Status last verified
Dec 2016
First submitted
24 Nov 2016
Last updated
22 Dec 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Rombeek M, De Jesus S, Altamirano-Diaz L, Welisch E, Prapavessis H, Seabrook JA, Norozi K. The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial. Pilot Feasibility Stud. 2017 Nov 15;3:59. doi: 10.1186/s40814-017-0207-y. eCollection 2017.

    PubMed 29167745

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle intervention in people with Congenital Heart Disease and Pediatric Obesity, run by Kambiz Norozi.

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 4 inclusion and 2 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 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Baseline Body Mass Index (BMI) at 1 year (time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame). The study lists 8 primary outcomes in all. 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 NCT02980393, which also lists 1 linked publication.

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 22 Dec 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in