Diabetes Mellitus, Type 2NCT01610219
Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth
A study testing Lifestyle Modification for Type 2 Diabetes Prevention and Nutrition and Physical Activity in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a concerning public health trend. There has been little research testing ways to prevent the development of this disease in children who are at increased risk to develop T2D. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Lifestyle Modification for Type 2 Diabetes Prevention and Nutrition and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jan 2011
- 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 4-8 years old
- Age- and sex-specific BMI ≥95th percentile
Who cannot join
- Children with serious medical conditions
- Children who show signs of elevated psychopathology, as assessed by the Child Behavior Checklist (CBCL)
- Children of parents with significantly elevated psychiatric disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Center for Weight and Eating Disorders/Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
About this study
The number of youth with Type 2 diabetes (T2D) is rising in the population, which is a concerning public health trend. There has been little research testing ways to prevent the development of this disease in children who are at increased risk to develop T2D. This study tests a family treatment program that treats 4-8 year old children who are at risk for T2D because they are overweight and have a family history of the disease. Sixty at risk children and their parents were assigned to one of 2 treatment conditions. Half of the families (randomly determined) received an intensive family treatment program that trains parents in how to increase healthier foods choices and physical activity for themselves and their children using "behavior modification" strategies. Children receiving this treatment were allowed to taste new fruits and vegetables used a pedometer to record how far they walked every day, and were given a "tool box" of toys and interactive games which promoted physical activity. The other half of the families only received instruction about healthier choices, but received no behavioral modification strategies or physical activity promotion tools. Improvements in children's body weight, blood measures, and behavior patterns were measured after treatment ended (6 months) and then again after 12 months. The results may lead to a better understanding of how family members can positively influence young children's behaviors to help prevent T2D. The objective of proposed study was to test a family-based intervention designed to reduce excess body weight, improve metabolic and cardiovascular profile, and improve diet and physical activity levels in 4 - 8 year old youth who are "at risk" for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial.
Primary Hypotheses:
Read more
- Compared to children receiving NPA, children receiving LMDP will show greater reductions in excess body weight, greater improvements in metabolic and cardiovascular measures, improved diet, increased physical activity, and reduced television viewing.
- Greater reductions in child excess body weight will be associated with greater improvements in metabolic and cardiovascular measures.
Secondary Hypotheses:
- Compared to parents receiving the NPA intervention, parents receiving the LMDP intervention will show greater reductions in BMI.
- Greater improvements in parent BMI will be associated with greater improvements in child body composition, metabolic and cardiovascular measures, and behavioral outcomes.
- Compared to families receiving the NPA intervention, families receiving the LMDP intervention will show an increase in the number of fruits and vegetables and lower energy density foods stored at home.
Read the detailed description
There is mounting concern about the development of Type 2 diabetes (T2D) in youth, especially in light of rising childhood obesity rates at younger ages. The health costs of T2D are notable both for the individual and society, and so interventions that can help prevent the development of T2D in early life are needed. Fortunately, there is promising evidence from the Diabetes Prevention Program (DPP) and other randomized trials with adults that the onset of T2D can be prevented through sustainable lifestyle changes. However, intervention programs have not been tested in young children who are "at risk" for developing the disease, even though this may be a critical period for obesity onset and for the formation of early eating and physical activity habits.
The primary aim of the proposed study was to test a family-based intervention that targets improvements in excess weight gain, metabolic and cardiovascular profile, and diet and physical activity in 4 - 8 year old children who are "at risk" for T2D. Specifically, 60 families were randomized either to one of two treatments: Lifestyle Modification for Diabetes Prevention (LMDP, N= 30) or Nutrition and Physical Activity Information (NPA, N= 30). The LMDP intervention trained families in behavioral strategies to increase parent and child intake of fruits, vegetables, and high fiber foods, to limit intake of energy-dense foods, and to increase daily physical activity. A physical activity "tool kit" for the home environment was provided to families. Supporting information about T2D and obesity, as well as nutrition and physical activity, also were provided. Besides the participating parent-child pair, other adult family members with T2D (eg, grandparents, aunts, uncles) were encouraged to participate. The LMDP activities were intended to reduce children's excess body weight and improve their metabolic and cardiovascular measures, to help prevent the onset of insulin resistance. The NPA intervention only received basic information on T2D and obesity, and nutrition and physical activity recommendations. Changes in child body composition, metabolic and cardiovascular measures, and behavioral outcomes were evaluated at 6 months (ie, end-of-treatment) and 12 months (ie, follow up). Changes in parent weight status and the home food environment were secondary outcomes and were assessed as potential mediators of child outcomes.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Lifestyle Modification for Type 2 Diabetes Prevention, Nutrition and Physical Activity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Modification for Type 2 Diabetes PreventionBehavioural
Family based behavioral intervention utilizing Traffic Light Diet, self monitoring, goal setting, reinforcement and a tool kit containing physical activity-promoting items
Nutrition and Physical ActivityOther
This family based education program provided information on physical activity and healthy eating for parents and children.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification for Diabetes Prevention | Active comparator | Family based intervention utilizing Traffic Light Diet, self monitoring, parent behavioral skill training and tool kit of items promoting physical activity. Receives: Behavioral: Lifestyle Modification for Type 2 Diabetes Prevention |
| Nutrition and Physical Activity | Other | Family based intervention providing education on healthy eating and physical activity but no behavioral skills training, goal setting, self monitoring or physical activity toolkit. Receives: Other: Nutrition and Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Change in BMI will be measured from baseline to end of intervention (6 months) and and also from 6 months to 12 months.
Measured: Baseline, 6 and 12 months
BMI-z score
Change in BMI-z score will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months.
Measured: Baseline, 6 and 12 months
Percent overweight (% overweight)
Change in percent overweight will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months. Percent overweight is computed as a child's actual BMI minus the median BMI for a child of comparable sex and age, divided by 100.
Measured: Baseline, 6 and 12 months
Waist Circumference(cm)
Change in waist circumference (cm) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Measured: Baseline, 6 and 12 months
Systolic Blood Pressure
Change in systolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Measured: Baseline, 6 and 12 months
Diastolic Blood Pressure (mm Hg)
Change in diastolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Measured: Baseline, 6 and 12 months
Pulse
Change in resting pulse will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Measured: Baseline, 6 and 12 months
Physical Activity
Change in physical activity was measured from baseline to end of treatment (6 months) and from end of treatment to 12 months using an accelerometer. The accelerometer measured light, moderate and moderate-to-vigorous actity over 7 days.
Measured: Baseline, 6 and 12 months
Glucose
Change in blood glucose levels were measured at baseline, 6 and 12 months.
Measured: Baseline, 6 and 12 months
Insulin
Change in plasma insulin levels from baseline to end of treatment (6 months) and from 6 months to 12 months.
Measured: Baseline, 6 and 12 months
Change in HDL, LDL, Total Cholesterol and Triglycerides
Change in lipid profile measures from baseline to end of treatment (6 months) and from 6 months to 12 months.
Measured: Baseline, 6 and 12 months
Change in Dietary Intake
Change in energy (kcals/day), protein, carbohydrate, fat, cholesterol, saturated fat and fiber intake.
Measured: Baseline, 6 and 12 months
Secondary outcomes (1)
Change in Parent BMI
Change in parent BMI from baseline to end of treatment (6 months) and from 6 motnths to 12 months.
Measured: Baseline, 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 posted1 Jun 2012 (estimated)
- Study startAug 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Myles S Faith, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610219
- Sponsor's protocol ID
- 807106
- Status last verified
- May 2012
- First submitted
- 30 May 2012
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Modification for Type 2 Diabetes Prevention in Overweight Youth
- ClinicalTrials.gov ID
- NCT01610219
- Acronym / sponsor ID
- 807106
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Aug 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 1 Jun 2012 (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 number of youth with Type 2 diabetes (T2D) is rising in the population, which is a concerning public health trend. There has been little research testing ways to prevent the development of this disease in children who are at increased risk to develop T2D. This study tests a family treatment program that treats 4-8 year old children who are at risk for T2D because they are overweight and have a family history of the disease. Sixty at risk children and their parents were assigned to one of 2 treatment conditions. Half of the families (randomly determined) received an intensive family treatment program that trains parents in how to increase healthier foods choices and physical activity for themselves and their children using "behavior modification" strategies. Children receiving this treatment were allowed to taste new fruits and vegetables used a pedometer to record how far they walked every day, and were given a "tool box" of toys and interactive games which promoted physical activity. The other half of the families only received instruction about healthier choices, but received no behavioral modification strategies or physical activity promotion tools. Improvements in children's body weight, blood measures, and behavior patterns were measured after treatment ended (6 months) and then again after 12 months. The results may lead to a better understanding of how family members can positively influence young children's behaviors to help prevent T2D. The objective of proposed study was to test a family-based intervention designed to reduce excess body weight, improve metabolic and cardiovascular profile, and improve diet and physical activity levels in 4 - 8 year old youth who are "at risk" for T2D. This intervention was tested in a 2-arm randomized controlled clinical trial.
Primary Hypotheses:
- Compared to children receiving NPA, children receiving LMDP will show greater reductions in excess body weight, greater improvements in metabolic and cardiovascular measures, improved diet, increased physical activity, and reduced television viewing.
- Greater reductions in child excess body weight will be associated with greater improvements in metabolic and cardiovascular measures.
Secondary Hypotheses:
- Compared to parents receiving the NPA intervention, parents receiving the LMDP intervention will show greater reductions in BMI.
- Greater improvements in parent BMI will be associated with greater improvements in child body composition, metabolic and cardiovascular measures, and behavioral outcomes.
- Compared to families receiving the NPA intervention, families receiving the LMDP intervention will show an increase in the number of fruits and vegetables and lower energy density foods stored at home.
Detailed description
There is mounting concern about the development of Type 2 diabetes (T2D) in youth, especially in light of rising childhood obesity rates at younger ages. The health costs of T2D are notable both for the individual and society, and so interventions that can help prevent the development of T2D in early life are needed. Fortunately, there is promising evidence from the Diabetes Prevention Program (DPP) and other randomized trials with adults that the onset of T2D can be prevented through sustainable lifestyle changes. However, intervention programs have not been tested in young children who are "at risk" for developing the disease, even though this may be a critical period for obesity onset and for the formation of early eating and physical activity habits.
The primary aim of the proposed study was to test a family-based intervention that targets improvements in excess weight gain, metabolic and cardiovascular profile, and diet and physical activity in 4 - 8 year old children who are "at risk" for T2D. Specifically, 60 families were randomized either to one of two treatments: Lifestyle Modification for Diabetes Prevention (LMDP, N= 30) or Nutrition and Physical Activity Information (NPA, N= 30). The LMDP intervention trained families in behavioral strategies to increase parent and child intake of fruits, vegetables, and high fiber foods, to limit intake of energy-dense foods, and to increase daily physical activity. A physical activity "tool kit" for the home environment was provided to families. Supporting information about T2D and obesity, as well as nutrition and physical activity, also were provided. Besides the participating parent-child pair, other adult family members with T2D (eg, grandparents, aunts, uncles) were encouraged to participate. The LMDP activities were intended to reduce children's excess body weight and improve their metabolic and cardiovascular measures, to help prevent the onset of insulin resistance. The NPA intervention only received basic information on T2D and obesity, and nutrition and physical activity recommendations. Changes in child body composition, metabolic and cardiovascular measures, and behavioral outcomes were evaluated at 6 months (ie, end-of-treatment) and 12 months (ie, follow up). Changes in parent weight status and the home food environment were secondary outcomes and were assessed as potential mediators of child outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification for Diabetes Prevention | Active comparator | Behavioral: Lifestyle Modification for Type 2 Diabetes PreventionFamily based intervention utilizing Traffic Light Diet, self monitoring, parent behavioral skill training and tool kit of items promoting physical activity. |
| Nutrition and Physical Activity | Other | Other: Nutrition and Physical ActivityFamily based intervention providing education on healthy eating and physical activity but no behavioral skills training, goal setting, self monitoring or physical activity toolkit. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 4-8 years old
- Age- and sex-specific BMI ≥95th percentile
Key exclusion criteria (3 listed)
- Children with serious medical conditions
- Children who show signs of elevated psychopathology, as assessed by the Child Behavior Checklist (CBCL)
- Children of parents with significantly elevated psychiatric disorders
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 |
|---|---|---|
| Lifestyle Modification for Type 2 Diabetes PreventionFamily based behavioral intervention utilizing Traffic Light Diet, self monitoring, goal setting, reinforcement and a tool kit containing physical activity-promoting items | Behavioural | Lifestyle Modification for Diabetes Prevention |
| Nutrition and Physical ActivityThis family based education program provided information on physical activity and healthy eating for parents and children. | Other | Nutrition and Physical Activity |
Primary outcome
Body Mass Index (BMI)
Time frame: Baseline, 6 and 12 months
Change in BMI will be measured from baseline to end of intervention (6 months) and and also from 6 months to 12 months.
BMI-z score
Time frame: Baseline, 6 and 12 months
Change in BMI-z score will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months.
Percent overweight (% overweight)
Time frame: Baseline, 6 and 12 months
Change in percent overweight will be measured from baseline to end of treatment (6 months) and from 6 months to 12 months. Percent overweight is computed as a child's actual BMI minus the median BMI for a child of comparable sex and age, divided by 100.
Waist Circumference(cm)
Time frame: Baseline, 6 and 12 months
Change in waist circumference (cm) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Systolic Blood Pressure
Time frame: Baseline, 6 and 12 months
Change in systolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Diastolic Blood Pressure (mm Hg)
Time frame: Baseline, 6 and 12 months
Change in diastolic blood pressure (mm Hg) will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Pulse
Time frame: Baseline, 6 and 12 months
Change in resting pulse will be measured from baseline to end of treatment (6 months) and from end of treatment to 12 months.
Physical Activity
Time frame: Baseline, 6 and 12 months
Change in physical activity was measured from baseline to end of treatment (6 months) and from end of treatment to 12 months using an accelerometer. The accelerometer measured light, moderate and moderate-to-vigorous actity over 7 days.
Glucose
Time frame: Baseline, 6 and 12 months
Change in blood glucose levels were measured at baseline, 6 and 12 months.
Insulin
Time frame: Baseline, 6 and 12 months
Change in plasma insulin levels from baseline to end of treatment (6 months) and from 6 months to 12 months.
Change in HDL, LDL, Total Cholesterol and Triglycerides
Time frame: Baseline, 6 and 12 months
Change in lipid profile measures from baseline to end of treatment (6 months) and from 6 months to 12 months.
Change in Dietary Intake
Time frame: Baseline, 6 and 12 months
Change in energy (kcals/day), protein, carbohydrate, fat, cholesterol, saturated fat and fiber intake.
1 secondary outcome
Change in Parent BMI
Time frame: Baseline, 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 Jun 2012.
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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.
Myles S Faith, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification for Type 2 Diabetes Prevention and Nutrition and Physical Activity in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Pennsylvania 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 Jun 2012. 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?
Body Mass Index (BMI) (time frame: Baseline, 6 and 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2012.