Childhood ObesityNCT03728621
Lifestyle Interventions and Metabolic Profile in Obese Children
A study testing Normocaloric and balanced diet, physical activity in people with Childhood Obesity and Obesity, run by University of Milan at 1 site in Italy.
Trial summary
This study evaluates if promotion of a normocaloric and balanced diet and of physical activity, through an individual- or group-based lifestyle intervention of 12 months, may affect anthropometric measurements and metabolic profile in obese children. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Childhood Obesity, Obesity, Pediatric Obesity
- What is being tested?
- Normocaloric and balanced diet, physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2012to Jun 2018
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Obesity confirmed by BMI z-score >2 according to WHO growth charts
- Age at recruitment ≥6 years
- weight at birth ≥2500 g and <4000 g
- gestational age 37-42 weeks
- single birth
- Caucasian ethny
- family residing in Milan or neighborhood (≤30 km)
Who cannot join
- Syndromic, organic and hormonal conditions besides obesity
- Age at recruitment <6 years
- Low birthweight (<2500 g), birthweight >4000 g
- Pre-term or post-term birth
- Twin delivery
- Other ethnies than Caucasian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individual Versus Group-based Lifestyle Intervention in Obese Children: Effects on Anthropometry and Metabolic Profile
This study evaluates if promotion of a normocaloric and balanced diet and of physical activity, through an individual- or group-based lifestyle intervention of 12 months, may affect anthropometric measurements and metabolic profile in obese children.
Read the detailed description
Obese children are at risk of metabolic and cardiovascular complications both during pediatric age and later and they often show components of metabolic syndrome, such as dyslipidemia, hypertension and disturbed glucose metabolism . These complications are strictly associated with insulin resistance/hyperinsulinemia which is one of the most important contributing factors to cardiovascular disease. The gold standard technique to determine whole-body insulin sensitivity, the hyperinsulinemic-euglycemic clamp, is expensive, invasive and requires considerable expertise to be performed. Therefore, several surrogate measures have been developed. Among these, the triglyceride-glucose index (TyG) is a useful indicator, providing an easily and widely available simple laboratory method as a surrogate to estimate insulin resistance in adult, children and adolescents. Other useful indicators of insulin resistance and insulin sensitivity are the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check (QUICK) index, respectively, while HOMA-β% is useful to evaluate pancreatic β-cell function.
Among cardiovascular complications, obesity-related atherogenic dyslipidemia is a risk factor for cardiovascular disease. In childhood, atherogenic dyslipidemia may be associated with structural and functional vascular changes, as increased carotid intima-media thickness and increased arterial stiffness. The atherogenic index of plasma (AIP) is a recognized valuable indicator of the size of pre- and anti-atherogenic lipoprotein particle and is considered a major predictive marker of atherosclerosis risk. Additionally, it might be more promising than other lipid variables in assessing cardiovascular risk.
Guidelines for treatment of childhood obesity recommend intensive lifestyle interventions, involving diet, physical activity and behavior change, in an age-appropriate manner. While it is recognized that these interventions could favorably influence some variables of metabolic profile of obese children, no study has reported accurate possible effect on triglyceride-glucose index and atherogenic index of plasma. Furthermore, pediatric obesity interventions may be group and/or individual-based. The group-based intervention requires less resources, children may benefit from a positive social environment, but the attention to individual needs is limited, which may weaken outcomes. On the other hand, the individual-based intervention allows to tailor dietary and physical counselling on individual's needs but is more expensive and requires greater resources.
The aims of the study are to establish in patients who undergone individual versus group based intervention:
- Effect on adiposity measured by BMI-zScore
- effect on gluco-insulin metabolism evaluated by homa-index
- effect on lipid profile evaluated by aterogenic index (AIP)
- Conditions
- Childhood Obesity, Obesity, Pediatric Obesity, Dyslipidemias, Cardiovascular Risk Factor, Life Style
- Being tested
- Normocaloric and balanced diet, physical activity
- Keywords
- obesity, child, AIP, lifestyle intervention
- Medical subject headings
- Pediatric Obesity, Obesity, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normocaloric and balanced diet, physical activityBehavioural
Promotion of normocaloric \& balanced diet and physical activity
| Study group | Role | What they receive |
|---|---|---|
| Individual-based lifestyle intervention | Experimental | Promotion of normocaloric \& balanced diet and physical activity Receives: Behavioral: Normocaloric and balanced diet, physical activity |
| Group-based lifestyle intervention | Experimental | Promotion of normocaloric \& balanced diet and physical activity Receives: Behavioral: Normocaloric and balanced diet, physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Expressed in meters
Measured: 0 (t0)-12 months (t1)
Blood levels of total cholesterol
Measured: 0 (t0)-12 months (t1)
Weight
Expressed in Kilograms
Measured: 0 (t0)-12 months (t1)
Body Mass Index (BMI)
Expressed in kg/m^2
Measured: 0 (t0)-12 months (t1)
Waist-to-height ratio
The ratio between waist circumference (cm) and height (cm)
Measured: 0 (t0)-12 months (t1)
Waist circumference
Expressed in cm
Measured: 0 (t0)-12 months (t1)
Triceps Skinfold Thickness
Expressed in mm, measured with an accurate plicometer
Measured: 0 (t0)-12 months (t1)
Tanner Stage
Classification of sexual maturation according to Tanner criteria
Measured: 0 (t0)-12 months (t1)
Blood levels of LDL cholesterol
Measured: 0 (t0)-12 months (t1)
Blood levels of HDL cholesterol
Measured: 0 (t0)-12 months (t1)
Blood levels of triglycerides
Measured: 0 (t0)-12 months (t1)
Blood levels of apolipoprotein A1 (ApoA1)
Measured: 0 (t0)-12 months (t1)
Blood levels of apolipoprotein B (ApoB)
Measured: 0 (t0)-12 months (t1)
Blood levels of insulin
Measured: 0 (t0)-12 months (t1)
Blood levels of glucose
Measured: 0 (t0)-12 months (t1)
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR)
calculated as the product of fasting glucose (mmol/L) and fasting insulin (U/mL) divided by 22.5
Measured: 0 (t0)-12 months (t1)
QUantitative Insulin sensitivity ChecK (QUICK) index
1/[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)]
Measured: 0 (t0)-12 months (t1)
HOMA-β%
[20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5]
Measured: 0 (t0)-12 months (t1)
Triglyceride-Glucose index (TyG index)
ln[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2]
Measured: 0 (t0)-12 months (t1)
Atherogenic Index of Plasma (AIP)
log10 of the ratio of plasma triglycerides to HDL-cholesterol
Measured: 0 (t0)-12 months (t1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study startJan 2012
- Primary completionJun 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies 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
- Model description
- This is a randomized, prospective, controlled study of 12 months a total of 170 children were consecutively recruited among those with diagnosis of obesity (in accordance with World Health Organization (WHO) criteria) by primary care pediatricians and admitted to the Department of Pediatrics, San Paolo Hospital, Milan, Italy, between January 2012 and June 2017. Inclusion criteria were: age at recruitment ≥6 years; weight at birth ≥2500 g and \<4000 g; gestational age 37-42 weeks; single birth; Caucasian race; family residing in Milan or neighborhood (≤30 km). Children having syndromic, organic and hormonal conditions besides obesity were excluded.
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvira Verduci, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728621
- Sponsor's protocol ID
- 139/2010/CE
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verduci E, Banderali G, Di Profio E, Vizzuso S, Zuccotti G, Radaelli G. Effect of individual- versus collective-based nutritional-lifestyle intervention on the atherogenic index of plasma in children with obesity: a randomized trial. Nutr Metab (Lond). 2021 Jan 13;18(1):11. doi: 10.1186/s12986-020-00537-w.
PubMed 33436021
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Versus Group-based Lifestyle Intervention in Obese Children: Effects on Anthropometry and Metabolic Profile
- ClinicalTrials.gov ID
- NCT03728621
- Acronym / sponsor ID
- 139/2010/CE
- Conditions
- Childhood Obesity, Obesity, Pediatric Obesity, Dyslipidemias, Cardiovascular Risk Factor, Life Style
- Keywords
- obesity, child, AIP, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates if promotion of a normocaloric and balanced diet and of physical activity, through an individual- or group-based lifestyle intervention of 12 months, may affect anthropometric measurements and metabolic profile in obese children.
Detailed description
Obese children are at risk of metabolic and cardiovascular complications both during pediatric age and later and they often show components of metabolic syndrome, such as dyslipidemia, hypertension and disturbed glucose metabolism . These complications are strictly associated with insulin resistance/hyperinsulinemia which is one of the most important contributing factors to cardiovascular disease. The gold standard technique to determine whole-body insulin sensitivity, the hyperinsulinemic-euglycemic clamp, is expensive, invasive and requires considerable expertise to be performed. Therefore, several surrogate measures have been developed. Among these, the triglyceride-glucose index (TyG) is a useful indicator, providing an easily and widely available simple laboratory method as a surrogate to estimate insulin resistance in adult, children and adolescents. Other useful indicators of insulin resistance and insulin sensitivity are the homeostatic model assessment of insulin resistance (HOMA-IR) and the quantitative insulin sensitivity check (QUICK) index, respectively, while HOMA-β% is useful to evaluate pancreatic β-cell function.
Among cardiovascular complications, obesity-related atherogenic dyslipidemia is a risk factor for cardiovascular disease. In childhood, atherogenic dyslipidemia may be associated with structural and functional vascular changes, as increased carotid intima-media thickness and increased arterial stiffness. The atherogenic index of plasma (AIP) is a recognized valuable indicator of the size of pre- and anti-atherogenic lipoprotein particle and is considered a major predictive marker of atherosclerosis risk. Additionally, it might be more promising than other lipid variables in assessing cardiovascular risk.
Guidelines for treatment of childhood obesity recommend intensive lifestyle interventions, involving diet, physical activity and behavior change, in an age-appropriate manner. While it is recognized that these interventions could favorably influence some variables of metabolic profile of obese children, no study has reported accurate possible effect on triglyceride-glucose index and atherogenic index of plasma. Furthermore, pediatric obesity interventions may be group and/or individual-based. The group-based intervention requires less resources, children may benefit from a positive social environment, but the attention to individual needs is limited, which may weaken outcomes. On the other hand, the individual-based intervention allows to tailor dietary and physical counselling on individual's needs but is more expensive and requires greater resources.
The aims of the study are to establish in patients who undergone individual versus group based intervention:
- Effect on adiposity measured by BMI-zScore
- effect on gluco-insulin metabolism evaluated by homa-index
- effect on lipid profile evaluated by aterogenic index (AIP)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, prospective, controlled study of 12 months a total of 170 children were consecutively recruited among those with diagnosis of obesity (in accordance with World Health Organization (WHO) criteria) by primary care pediatricians and admitted to the Department of Pediatrics, San Paolo Hospital, Milan, Italy, between January 2012 and June 2017. Inclusion criteria were: age at recruitment ≥6 years; weight at birth ≥2500 g and <4000 g; gestational age 37-42 weeks; single birth; Caucasian race; family residing in Milan or neighborhood (≤30 km). Children having syndromic, organic and hormonal conditions besides obesity were excluded.
| Arm | Type | Receives |
|---|---|---|
| Individual-based lifestyle intervention | Experimental | Behavioral: Normocaloric and balanced diet, physical activityPromotion of normocaloric \& balanced diet and physical activity |
| Group-based lifestyle intervention | Experimental | Behavioral: Normocaloric and balanced diet, physical activityPromotion of normocaloric \& balanced diet and physical activity |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Obesity confirmed by BMI z-score >2 according to WHO growth charts
- Age at recruitment ≥6 years
- weight at birth ≥2500 g and <4000 g
- gestational age 37-42 weeks
- single birth
Key exclusion criteria (6 listed)
- Syndromic, organic and hormonal conditions besides obesity
- Age at recruitment <6 years
- Low birthweight (<2500 g), birthweight >4000 g
- Pre-term or post-term birth
- Twin delivery
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 |
|---|---|---|
| Normocaloric and balanced diet, physical activityPromotion of normocaloric \& balanced diet and physical activity | Behavioural | Group-based lifestyle intervention, Individual-based lifestyle intervention |
Primary outcome
Height
Time frame: 0 (t0)-12 months (t1)
Expressed in meters
Blood levels of total cholesterol
Time frame: 0 (t0)-12 months (t1)
Weight
Time frame: 0 (t0)-12 months (t1)
Expressed in Kilograms
Body Mass Index (BMI)
Time frame: 0 (t0)-12 months (t1)
Expressed in kg/m^2
Waist-to-height ratio
Time frame: 0 (t0)-12 months (t1)
The ratio between waist circumference (cm) and height (cm)
Waist circumference
Time frame: 0 (t0)-12 months (t1)
Expressed in cm
Triceps Skinfold Thickness
Time frame: 0 (t0)-12 months (t1)
Expressed in mm, measured with an accurate plicometer
Tanner Stage
Time frame: 0 (t0)-12 months (t1)
Classification of sexual maturation according to Tanner criteria
Blood levels of LDL cholesterol
Time frame: 0 (t0)-12 months (t1)
Blood levels of HDL cholesterol
Time frame: 0 (t0)-12 months (t1)
Blood levels of triglycerides
Time frame: 0 (t0)-12 months (t1)
Blood levels of apolipoprotein A1 (ApoA1)
Time frame: 0 (t0)-12 months (t1)
Blood levels of apolipoprotein B (ApoB)
Time frame: 0 (t0)-12 months (t1)
Blood levels of insulin
Time frame: 0 (t0)-12 months (t1)
Blood levels of glucose
Time frame: 0 (t0)-12 months (t1)
HOmeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 0 (t0)-12 months (t1)
calculated as the product of fasting glucose (mmol/L) and fasting insulin (U/mL) divided by 22.5
QUantitative Insulin sensitivity ChecK (QUICK) index
Time frame: 0 (t0)-12 months (t1)
1/[log10 fasting plasma insulin (U/mL) + log10 glucose (mg/dL)]
HOMA-β%
Time frame: 0 (t0)-12 months (t1)
[20 fasting insulin in (U/mL)/(fasting glucose (mmol/L) - 3.5]
Triglyceride-Glucose index (TyG index)
Time frame: 0 (t0)-12 months (t1)
ln[fasting triglycerides (mg/dL) fasting glucose (mg/dL)/2]
Atherogenic Index of Plasma (AIP)
Time frame: 0 (t0)-12 months (t1)
log10 of the ratio of plasma triglycerides to HDL-cholesterol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Derived from this study: PubMed 33436021Verduci E, Banderali G, Di Profio E, Vizzuso S, Zuccotti G, Radaelli G. Effect of individual- versus collective-based nutritional-lifestyle intervention on the atherogenic index of plasma in children with obesity: a randomized trial. Nutr Metab (Lond). 2021 Jan 13;18(1):11. doi: 10.1186/s12986-020-00537-w.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normocaloric and balanced diet, physical activity in people with Childhood Obesity and Obesity, run by University of Milan at 1 site in Italy.
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 7 inclusion and 6 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 2 Nov 2018. 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 Italy. 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?
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?
Height (time frame: 0 (t0)-12 months (t1)). The study lists 20 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 NCT03728621, 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 2 Nov 2018.