Pediatric ObesityFBINCT01146314
A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
A study testing Family Focused Lifestyle Intervention in people with Pediatric Obesity and Type 2 Diabetes, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The purpose of this study was to determine if a family-focused lifestyle intervention helps to improve the health status, behaviors, and adjustment of overweight children. Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Pediatric Obesity, Type 2 Diabetes, Metabolic Syndrome
- What is being tested?
- Family Focused Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Mar 2010
- 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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI 85th percentile and above, otherwise healthy
- Age between 8-11 years old
Who cannot join
- Diagnosis of metabolic syndrome
- Diagnosis of type 2 diabetes
- Diagnosis of Mental Retardation
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
The purpose of this study was to determine if a family-focused lifestyle intervention helps to improve the health status, behaviors, and adjustment of overweight children.
Read the detailed description
Type 2 diabetes (DM2), and obesity is increasing dramatically in the United States and worldwide among children. Even before children are diagnosed with DM2, they often show signs such as being overweight, having high blood pressure, abnormal lipid metabolism, and impaired glucose tolerance that put them at risk for other diseases, such as heart disease. In addition, children who are at risk for DM2 also face elevated risks of other major medical complications along with psychological and social consequences (e.g., depression, teasing, discrimination, school problems), which can often be just as damaging as the medical problems. Since obesity plays an important role in the progression to DM2, the need to prevent children from progressing to a diagnosis of DM2 is critical.
The proposed study was a randomized controlled trial comparing an education group for families of children at high risk for progression to metabolic syndrome and type 2 diabetes with a family-focused multi-component lifestyle intervention. The study addressed these specific aims:
- Evaluated the effects of a family-focused lifestyle intervention on the health status of children at risk of metabolic syndrome (BMI, blood pressure, cholesterol, impaired glucose tolerance, waist circumference).
- Evaluated the effects of a family focused psychosocial treatment on the health behaviors of children at risk for developing metabolic syndrome (eating behaviors, physical activity).
- Evaluated the effects of a family focused psychosocial treatment on psychological outcomes of children at risk of developing metabolic syndrome (overall behavioral functioning, perception, self esteem, depression, quality of life).
- Analyzed variables that are predictive of maintenance or termination of engagement in the family-focused lifestyle intervention.
It was hypothesized that this intervention approach will result in: a) improved health status and a reduction of risk for developing metabolic syndrome (BMI, waist circumference, blood pressure, cholesterol, and glucose levels), b) improved health behaviors (physical activity, diet), and c) generalize to more optimal psychosocial functioning (depression, self-perception, quality of life, school attendance) at short and long-term follow-up of the children in the intervention group compared with children in the education group.
- Conditions
- Pediatric Obesity, Type 2 Diabetes, Metabolic Syndrome
- Being tested
- Family Focused Lifestyle Intervention
- Keywords
- family-focused intervention, pediatric obesity, diabetes prevention
- Medical subject headings
- Pediatric Obesity, Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Focused Lifestyle InterventionBehavioural
The lifestyle intervention is a 6-month intervention study lasting 6 months. The intervention is 14 sessions and conducted by a dietician and psychologist in a group setting with each intervention session lasting 90 minutes. The sessions are conducted weekly, biweekly, and monthly over the course of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | A 6-month 14 session lifestyle intervention led by a psychologist and a dietitian for 90 minutes group sessions. Intervention sessions were help weekly, biweekly, and monthly over the course of 6 months. Receives: Behavioral: Family Focused Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of health status of overweight children
Evaluated the effects of the intervention on improving BMI, blood pressure, waist circumference, and reducing the risk of the development of type 2 diabetes and metabolic syndrome.
Measured: Measured at 6 and 12 months
Secondary outcomes (1)
Improvement of health behaviors and psychosocial adjustment
Evaluated the effects of the intervention on changing health behaviors, such as eating patterns, diet, and eating behavior, and evaluate the effects of maintaining of improving adjustment to psychological stressors associated with being overweight (self esteem, depression, behavior).
Measured: Measured at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startSep 2006
- Primary completionDec 2009
- Study completionMar 2010
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 Pediatric 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
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Amanda Lochrie, Nemours Children's Clinic
- Investigators
- Amanda S Lochrie, PhD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146314
- Sponsor's protocol ID
- 18-06038-001
- Other IDs
- 1-06-JF-33
- Acronym
- FBI
- Status last verified
- Apr 2013
- First submitted
- 16 Jun 2010
- Last updated
- 1 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kahhan N, Hossain MJ, Lang J, Harrison C, Canas J, Wysocki T, Lochrie A, Balagopal PB. Durability of Changes in Biomarkers of Cardiometabolic Disease: 1-Year Family-Based Intervention in Children with Obesity. Metab Syndr Relat Disord. 2021 Jun;19(5):264-271. doi: 10.1089/met.2020.0097. Epub 2021 Mar 1.
PubMed 33650888
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children
- ClinicalTrials.gov ID
- NCT01146314
- Acronym / sponsor ID
- FBI / 18-06038-001
- Conditions
- Pediatric Obesity, Type 2 Diabetes, Metabolic Syndrome
- Keywords
- family-focused intervention, pediatric obesity, diabetes prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Sep 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Jun 2010 (estimated)
- 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.
The purpose of this study was to determine if a family-focused lifestyle intervention helps to improve the health status, behaviors, and adjustment of overweight children.
Detailed description
Type 2 diabetes (DM2), and obesity is increasing dramatically in the United States and worldwide among children. Even before children are diagnosed with DM2, they often show signs such as being overweight, having high blood pressure, abnormal lipid metabolism, and impaired glucose tolerance that put them at risk for other diseases, such as heart disease. In addition, children who are at risk for DM2 also face elevated risks of other major medical complications along with psychological and social consequences (e.g., depression, teasing, discrimination, school problems), which can often be just as damaging as the medical problems. Since obesity plays an important role in the progression to DM2, the need to prevent children from progressing to a diagnosis of DM2 is critical.
The proposed study was a randomized controlled trial comparing an education group for families of children at high risk for progression to metabolic syndrome and type 2 diabetes with a family-focused multi-component lifestyle intervention. The study addressed these specific aims:
- Evaluated the effects of a family-focused lifestyle intervention on the health status of children at risk of metabolic syndrome (BMI, blood pressure, cholesterol, impaired glucose tolerance, waist circumference).
- Evaluated the effects of a family focused psychosocial treatment on the health behaviors of children at risk for developing metabolic syndrome (eating behaviors, physical activity).
- Evaluated the effects of a family focused psychosocial treatment on psychological outcomes of children at risk of developing metabolic syndrome (overall behavioral functioning, perception, self esteem, depression, quality of life).
- Analyzed variables that are predictive of maintenance or termination of engagement in the family-focused lifestyle intervention.
It was hypothesized that this intervention approach will result in: a) improved health status and a reduction of risk for developing metabolic syndrome (BMI, waist circumference, blood pressure, cholesterol, and glucose levels), b) improved health behaviors (physical activity, diet), and c) generalize to more optimal psychosocial functioning (depression, self-perception, quality of life, school attendance) at short and long-term follow-up of the children in the intervention group compared with children in the education group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Behavioral: Family Focused Lifestyle InterventionA 6-month 14 session lifestyle intervention led by a psychologist and a dietitian for 90 minutes group sessions. Intervention sessions were help weekly, biweekly, and monthly over the course of 6 months. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- BMI 85th percentile and above, otherwise healthy
- Age between 8-11 years old
Key exclusion criteria (3 listed)
- Diagnosis of metabolic syndrome
- Diagnosis of type 2 diabetes
- Diagnosis of Mental Retardation
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 |
|---|---|---|
| Family Focused Lifestyle InterventionThe lifestyle intervention is a 6-month intervention study lasting 6 months. The intervention is 14 sessions and conducted by a dietician and psychologist in a group setting with each intervention session lasting 90 minutes. The sessions are conducted weekly, biweekly, and monthly over the course of 6 months. | Behavioural | Lifestyle intervention |
Primary outcome
Improvement of health status of overweight children
Time frame: Measured at 6 and 12 months
Evaluated the effects of the intervention on improving BMI, blood pressure, waist circumference, and reducing the risk of the development of type 2 diabetes and metabolic syndrome.
1 secondary outcome
Improvement of health behaviors and psychosocial adjustment
Time frame: Measured at 6 and 12 months
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 1 May 2013.
- Derived from this study: PubMed 33650888Kahhan N, Hossain MJ, Lang J, Harrison C, Canas J, Wysocki T, Lochrie A, Balagopal PB. Durability of Changes in Biomarkers of Cardiometabolic Disease: 1-Year Family-Based Intervention in Children with Obesity. Metab Syndr Relat Disord. 2021 Jun;19(5):264-271. doi: 10.1089/met.2020.0097. Epub 2021 Mar 1.
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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.
Amanda S Lochrie, PhD principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Focused Lifestyle Intervention in people with Pediatric Obesity and Type 2 Diabetes, run by Nemours Children's Clinic 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 3 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 1 May 2013. 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?
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?
Improvement of health status of overweight children (time frame: Measured at 6 and 12 months). 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 NCT01146314, 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 1 May 2013.