ObesityNCT00412165
PACE-iDP: An Intervention for Youth at Risk for Diabetes
A study testing Cell Phone, Weekly access to interactive web site and Group in people with Obesity and Overweight, run by University of California, San Diego at 1 site in United States.
Trial summary
This randomized control study (sponsored by the NIH, NIDDK) is aimed at reducing BMI in overweight adolescents at risk for the development of type 2 diabetes. The study will examine whether an integrated primary care, web and cell-phone-based intervention can produce initial and sustained improvements in… Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Obesity, Overweight, Diabetes
- What is being tested?
- Cell Phone, Weekly access to interactive web site and Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to May 2009
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Criteria for participation in the study include:
- Being overweight (BMI > 85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal for height). In addition, at least half of the study participants will have a BMI > 95th percentile for age and sex. Study participants will have a maximum body weight of 285 pounds.
- Adolescent subjects must also have at least two of the following risk factors:
- family history of type 2 diabetes in a first-or second-degree relative,
- race/ethnicity of American Indian, African-American, Hispanic, Asian/Pacific Islander, or
- signs of insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, or polycystic ovarian syndrome).
Show all 9Show fewer
- In addition, adolescent subjects must be able to read and speak English or Spanish, have access to the Internet at home, school, or work, be reachable at a telephone number, be willing to participate in monthly 90-minute group meetings, have plans to stay in the San Diego area for the one-year study period, and have an English or Spanish speaking parent/guardian also willing to participate in the study.
- Parental consent (obtained in parents primary language) and subject assent is also required.
- Participants must have a parent or guardian agree to enroll who is able to speak and read in English or Spanish, has ongoing access and uses the internet, and plans to reside in San Diego for the length of the study.
Who cannot join
- Subjects will be excluded from participation if they have any of the following conditions:
- Diabetes
- Pregnancy
- Cardiovascular problem, musculoskeletal problem or any medical condition that would limit their ability to comply with physical activity or dietary recommendations.
- Patients in foster care will be ineligible due to difficulty in obtaining follow-up measures.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD - CALIT2- Atkinson Hall
La Jolla, California, 92037
About this study
This randomized control study (sponsored by the NIH, NIDDK) is aimed at reducing BMI in overweight adolescents at risk for the development of type 2 diabetes. The study will examine whether an integrated primary care, web and cell-phone-based intervention can produce initial and sustained improvements in anthropometric, behavioral, metabolic, and physiological outcomes in overweight adolescents. The primary goal is to reduce BMI (Body Mass Index)in overweight adolescents.
Read the detailed description
Type 2 Diabetes Mellitus (DM) is a common disease that plagues over 16 million adults in the United States (American Diabetes Association [ADA], 2002). Over the past decade, the number of adults diagnosed with diabetes has risen dramatically. The high rates of type 2 diabetes have been associated with the simultaneously rapid increase in the prevalence of obesity, and diminished levels of physical activity in the population (Wing, 2001).
Type 2 diabetes is increasing in children and adolescents in the U.S. and worldwide (ADA, 2000). Several studies have demonstrated higher risk of type 2 diabetes in African-American, Hispanic, and American Indian children and adolescents (Glaser, 1997; Dean, 1992; Pinhas-Hamiel, 1996; Rosenbloom, 1999). Other characteristics, or risk factors, that may be used to identify children at high-risk for developing type 2 diabetes include obesity, family history, and physiologic manifestations of insulin resistance (ADA, 2000). Up to 85% of children with type 2 diabetes are overweight or obese at diagnosis. A majority of children with type 2 diabetes have at least one parent or first-degree relative with type 2 diabetes. Physiologic findings of insulin resistance that are present in large percentages of children with type 2 diabetes include acanthosis nigricans, polycystic ovarian syndrome, hypertension and lipid disorders (ADA, 2000). Among US children, the mean age at diagnosis of type 2 diabetes is between 12 and 14 years (Moran, 1999; Goran MI, 2001).
Obesity is commonly found in children with type 2 diabetes, and the increasing incidence of children with type 2 diabetes has been attributed to the growing problem of pediatric overweight and obesity (Fagot-Camapagna, et.al, 2000). It is often hypothesized that an industrialized, or "Westernized" lifestyle of excessive energy intake and sedentary behavior partially explains the recent emergence of type 2 diabetes and obesity in youth (Hill \& Peters, 1998; Koplan \& Dietz, 2000). Evidence that the number of years being obese is positively correlated with diabetes risk (Everhart, 1992), supports intervening in adolescence to minimize the number of years of obesity.
Obesity and physical inactivity are thought to be the main modifiable determinants of this disease, and interventions targeting diet and physical activity have been surprisingly effective in preventing diabetes in high-risk adults (Tuomilehto, 2001; NIDDK, 2001). There are no published studies that examine the efficacy of similar lifestyle interventions aimed at children and adolescents. Our rationale for intervening on these behaviors with high-risk adolescents is based on these findings, as well as the following: (a) the majority of adolescents do not meet current guidelines for physical activity and nutrition and (b) there is a steep age-related decline in physical activity that peaks in the teen years. In its March 2000 Consensus Statement of Type 2 Diabetes In Children and Adolescents, the ADA expert panel stated that, "Primary care providers have an obligation to encourage lifestyle modifications that might delay or prevent the onset of type 2 diabetes in children at high risk. Lifestyle interventions focusing on weight management and increasing physical activity should be promoted in all children at high risk for the development of type 2 diabetes." (ADA, 2000).
- Conditions
- Obesity, Overweight, Diabetes
- Being tested
- Cell Phone, Weekly access to interactive web site, Group
- Keywords
- Prevention of Type 2 Diabetes, Adolescents, Obesity, Overweight, Internet Technology, Cell Phone
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell PhoneBehavioural
The cell phone arm receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
Weekly access to interactive web siteBehavioural
This group receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
GroupBehavioural
The Group arm receives monthly face to face group sessions plus access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Usual care arm receives standard physical activity, nutrition and weight loss information from their primary care provider. The study offers and pays for a series of weight management sessions provided by Rady's Children's Hospital and Health Center's Nutrition Dept. |
| Intervention - Web | Experimental | This group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition. Receives: Behavioral: Weekly access to interactive web site |
| Intervention - Group | Experimental | This group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition and has access to monthly group session with other teen and parent participants. Receives: Behavioral: Group |
| Intervention - Cell Phone | Experimental | This group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition and are provided with cell phones to use during the program. The cell phone allows for the transfer of text messages from the study to the participant that are tailored to their health goals. In addition, self-monitoring and uploading capabilities to the program website are included. Receives: Behavioral: Cell Phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect, at 12 months, of the 3 intensities of the PACEi-DP intervention on Body Mass Index (BMI) among male & female adolescents.
Measured: baseline, 6 mo, 12 mo
Secondary outcomes (3)
at 6 and 12 months,the impact of the PACEi-DP interventions on:metabolic and physiological manifestations of insulin resistance
Measured: 6 mo, 12 mo
anthropometric measures including BMI at 6 months, waist to hip ratio at 6 and 12 months, percent body fat (DEXA) at 6 and 12 months,and
Measured: 6 mo, 12 mo
behavioral measures of diet and physical activity.
Measured: 6 mo, 12 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Patrick, MD, MS, University of California, San Diego
- Investigators
- Kevin Patrick, MD, MS, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412165
- Sponsor's protocol ID
- 5R18DK064321
- Other IDs
- UCSD#: 2006-4039
- Status last verified
- Aug 2012
- First submitted
- 13 Dec 2006
- Last updated
- 16 Aug 2012
- Results posted
- No
Publications
Kolodziejczyk JK, Gutzmer K, Wright SM, Arredondo EM, Hill L, Patrick K, Huang JS, Gottschalk M, Norman GJ. Influence of specific individual and environmental variables on the relationship between body mass index and health-related quality of life in overweight and obese adolescents. Qual Life Res. 2015 Jan;24(1):251-61. doi: 10.1007/s11136-014-0745-1. Epub 2014 Jul 1.
PubMed 24980678Patrick K, Norman GJ, Davila EP, Calfas KJ, Raab F, Gottschalk M, Sallis JF, Godbole S, Covin JR. Outcomes of a 12-month technology-based intervention to promote weight loss in adolescents at risk for type 2 diabetes. J Diabetes Sci Technol. 2013 May 1;7(3):759-70. doi: 10.1177/193229681300700322.
PubMed 23759410Huang JS, Gottschalk M, Norman GJ, Calfas KJ, Sallis JF, Patrick K. Compliance with behavioral guidelines for diet, physical activity and sedentary behaviors is related to insulin resistance among overweight and obese youth. BMC Res Notes. 2011 Feb 1;4:29. doi: 10.1186/1756-0500-4-29.
PubMed 21281521
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACE-iDP: An Intervention for Youth at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT00412165
- Acronym / sponsor ID
- 5R18DK064321
- Conditions
- Obesity, Overweight, Diabetes
- Keywords
- Prevention of Type 2 Diabetes, Adolescents, Obesity, Overweight, Internet Technology, Cell Phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Dec 2006 (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.
This randomized control study (sponsored by the NIH, NIDDK) is aimed at reducing BMI in overweight adolescents at risk for the development of type 2 diabetes. The study will examine whether an integrated primary care, web and cell-phone-based intervention can produce initial and sustained improvements in anthropometric, behavioral, metabolic, and physiological outcomes in overweight adolescents. The primary goal is to reduce BMI (Body Mass Index)in overweight adolescents.
Detailed description
Type 2 Diabetes Mellitus (DM) is a common disease that plagues over 16 million adults in the United States (American Diabetes Association [ADA], 2002). Over the past decade, the number of adults diagnosed with diabetes has risen dramatically. The high rates of type 2 diabetes have been associated with the simultaneously rapid increase in the prevalence of obesity, and diminished levels of physical activity in the population (Wing, 2001).
Type 2 diabetes is increasing in children and adolescents in the U.S. and worldwide (ADA, 2000). Several studies have demonstrated higher risk of type 2 diabetes in African-American, Hispanic, and American Indian children and adolescents (Glaser, 1997; Dean, 1992; Pinhas-Hamiel, 1996; Rosenbloom, 1999). Other characteristics, or risk factors, that may be used to identify children at high-risk for developing type 2 diabetes include obesity, family history, and physiologic manifestations of insulin resistance (ADA, 2000). Up to 85% of children with type 2 diabetes are overweight or obese at diagnosis. A majority of children with type 2 diabetes have at least one parent or first-degree relative with type 2 diabetes. Physiologic findings of insulin resistance that are present in large percentages of children with type 2 diabetes include acanthosis nigricans, polycystic ovarian syndrome, hypertension and lipid disorders (ADA, 2000). Among US children, the mean age at diagnosis of type 2 diabetes is between 12 and 14 years (Moran, 1999; Goran MI, 2001).
Obesity is commonly found in children with type 2 diabetes, and the increasing incidence of children with type 2 diabetes has been attributed to the growing problem of pediatric overweight and obesity (Fagot-Camapagna, et.al, 2000). It is often hypothesized that an industrialized, or "Westernized" lifestyle of excessive energy intake and sedentary behavior partially explains the recent emergence of type 2 diabetes and obesity in youth (Hill \& Peters, 1998; Koplan \& Dietz, 2000). Evidence that the number of years being obese is positively correlated with diabetes risk (Everhart, 1992), supports intervening in adolescence to minimize the number of years of obesity.
Obesity and physical inactivity are thought to be the main modifiable determinants of this disease, and interventions targeting diet and physical activity have been surprisingly effective in preventing diabetes in high-risk adults (Tuomilehto, 2001; NIDDK, 2001). There are no published studies that examine the efficacy of similar lifestyle interventions aimed at children and adolescents. Our rationale for intervening on these behaviors with high-risk adolescents is based on these findings, as well as the following: (a) the majority of adolescents do not meet current guidelines for physical activity and nutrition and (b) there is a steep age-related decline in physical activity that peaks in the teen years. In its March 2000 Consensus Statement of Type 2 Diabetes In Children and Adolescents, the ADA expert panel stated that, "Primary care providers have an obligation to encourage lifestyle modifications that might delay or prevent the onset of type 2 diabetes in children at high risk. Lifestyle interventions focusing on weight management and increasing physical activity should be promoted in all children at high risk for the development of type 2 diabetes." (ADA, 2000).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –Usual care arm receives standard physical activity, nutrition and weight loss information from their primary care provider. The study offers and pays for a series of weight management sessions provided by Rady's Children's Hospital and Health Center's Nutrition Dept. |
| Intervention - Web | Experimental | Behavioral: Weekly access to interactive web siteThis group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition. |
| Intervention - Group | Experimental | Behavioral: GroupThis group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition and has access to monthly group session with other teen and parent participants. |
| Intervention - Cell Phone | Experimental | Behavioral: Cell PhoneThis group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition and are provided with cell phones to use during the program. The cell phone allows for the transfer of text messages from the study to the participant that are tailored to their health goals. In addition, self-monitoring and uploading capabilities to the program website are included. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Being overweight (BMI > 85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal for height). In addition, at least half of the study participants will have a BMI > 95th percentile for age and sex. Study participants will have a maximum body weight of 285 pounds.
- Adolescent subjects must also have at least two of the following risk factors:
- In addition, adolescent subjects must be able to read and speak English or Spanish, have access to the Internet at home, school, or work, be reachable at a telephone number, be willing to participate in monthly 90-minute group meetings, have plans to stay in the San Diego area for the one-year study period, and have an English or Spanish speaking parent/guardian also willing to participate in the study.
- Parental consent (obtained in parents primary language) and subject assent is also required.
- Participants must have a parent or guardian agree to enroll who is able to speak and read in English or Spanish, has ongoing access and uses the internet, and plans to reside in San Diego for the length of the study.
Key exclusion criteria (5 listed)
- Subjects will be excluded from participation if they have any of the following conditions:
- Diabetes
- Pregnancy
- Cardiovascular problem, musculoskeletal problem or any medical condition that would limit their ability to comply with physical activity or dietary recommendations.
- Patients in foster care will be ineligible due to difficulty in obtaining follow-up measures.
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 |
|---|---|---|
| Cell PhoneThe cell phone arm receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail | Behavioural | Intervention - Cell Phone |
| Weekly access to interactive web siteThis group receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail | Behavioural | Intervention - Web |
| GroupThe Group arm receives monthly face to face group sessions plus access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail | Behavioural | Intervention - Group |
Primary outcome
To evaluate the effect, at 12 months, of the 3 intensities of the PACEi-DP intervention on Body Mass Index (BMI) among male & female adolescents.
Time frame: baseline, 6 mo, 12 mo
3 secondary outcomes
at 6 and 12 months,the impact of the PACEi-DP interventions on:metabolic and physiological manifestations of insulin resistance
Time frame: 6 mo, 12 mo
anthropometric measures including BMI at 6 months, waist to hip ratio at 6 and 12 months, percent body fat (DEXA) at 6 and 12 months,and
Time frame: 6 mo, 12 mo
behavioral measures of diet and physical activity.
Time frame: 6 mo, 12 mo
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 16 Aug 2012.
- Derived from this study: PubMed 24980678Kolodziejczyk JK, Gutzmer K, Wright SM, Arredondo EM, Hill L, Patrick K, Huang JS, Gottschalk M, Norman GJ. Influence of specific individual and environmental variables on the relationship between body mass index and health-related quality of life in overweight and obese adolescents. Qual Life Res. 2015 Jan;24(1):251-61. doi: 10.1007/s11136-014-0745-1. Epub 2014 Jul 1.
- Derived from this study: PubMed 23759410Patrick K, Norman GJ, Davila EP, Calfas KJ, Raab F, Gottschalk M, Sallis JF, Godbole S, Covin JR. Outcomes of a 12-month technology-based intervention to promote weight loss in adolescents at risk for type 2 diabetes. J Diabetes Sci Technol. 2013 May 1;7(3):759-70. doi: 10.1177/193229681300700322.
- Derived from this study: PubMed 21281521Huang JS, Gottschalk M, Norman GJ, Calfas KJ, Sallis JF, Patrick K. Compliance with behavioral guidelines for diet, physical activity and sedentary behaviors is related to insulin resistance among overweight and obese youth. BMC Res Notes. 2011 Feb 1;4:29. doi: 10.1186/1756-0500-4-29.
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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.
Kevin Patrick, MD, MS principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell Phone, Weekly access to interactive web site and Group in people with Obesity and Overweight, run by University of California, San Diego 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 9 inclusion and 5 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 16 Aug 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?
To evaluate the effect, at 12 months, of the 3 intensities of the PACEi-DP intervention on Body Mass Index (BMI) among male & female adolescents. (time frame: baseline, 6 mo, 12 mo). 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 NCT00412165, which also lists 3 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 16 Aug 2012.