ObesityNCT00063674
Type 2 Diabetes Primary Prevention for At Risk Girls
A study testing Nutrition Education and After-school dance class in people with Obesity and Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls. The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Read more about this study
- Who is it for?
- Ages 7 to 10 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes Mellitus, Pre Diabetes
- What is being tested?
- Nutrition Education and After-school dance class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to not given
- 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 10 years
- Women only
- Healthy volunteers accepted
- Child
Second-, third- and fourth-grade girls, aged 7-10 years of age enrolled in one of the participating schools will be eligible. Our goal is to be as inclusive as possible. However, girls will not be eligible to participate if they:
- have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease)
- are taking medications potentially affecting their growth and/or weight (e.g., methylphenidate HCl, systemic steroids)
- have Asthma (not exclusionary alone) but have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
- have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g., significant structural heart disease)
- are pregnant
- are unable to complete the informed consent process.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Palo Alto, California, 94304
About this study
Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls.
The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke.
Read more
Our Two Approaches:
- A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity.
- After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance.
Participants: Second, third and fourth grade girls and their families will be eligible to participate. All activities are free of charge. To be able to perform a valid evaluation, to be able to accommodate all girls at their own school, and to be fair about which girls receive which program, families who wish to participate will be randomly selected to participate in either one program or the other (nutrition education or dance classes). Each family will participate for two years.
Evaluation: Trained Stanford staff will perform all evaluation procedures with participating families in their own homes at the beginning and every six months. Families will be compensated for their participation.
- Conditions
- Obesity, Diabetes Mellitus, Pre Diabetes
- Being tested
- Nutrition Education, After-school dance class
- Keywords
- exercise, eating, dance, health education, obesity prevention, diabetes prevention, children
- Medical subject headings
- Obesity, Diabetes Mellitus, Glucose Intolerance, Motor Activity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
After-school dance classBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education | Active comparator | A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity. Receives: Behavioral: Nutrition Education |
| After-school dance class | Experimental | After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance. Receives: Behavioral: After-school dance class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
Change in body mass index (BMI) over the 2-year intervention period. BMI was calculated as weight in kilograms divided by height in meters squared.
Measured: 24 months
Secondary outcomes (6)
Change in Waist Circumference
Change in waist circumference measured in centimeters over the 24-month intervention period.
Measured: 24 months
Change in Total Cholesterol
Change in fasting serum total cholesterol level over the 24-month intervention period.
Measured: 24 months
Change in LDL Cholesterol Level
Change in fasting low-density lipoprotein (LDL) cholesterol level over the 24-month intervention period.
Measured: 24 months
Change in HDL Cholesterol Level
Change in fasting high-density lipoprotein (HDL) cholesterol level over the 24-month intervention period.
Measured: 24 months
Change in Fasting Glucose
Change in fasting serum glucose level over the 24-month intervention period.
Measured: 24 months
Change in Fasting Insulin
Change in fasting serum insulin level over the 24-month intervention period.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2003 (estimated)
- Study startApr 2003
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 ObesityStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Thomas N Robinson, MD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063674
- Sponsor's protocol ID
- T2DPPG (completed)
- Other IDs
- R01DK062360
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2003
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Robinson TN, Matheson DM, Kraemer HC, Wilson DM, Obarzanek E, Thompson NS, Alhassan S, Spencer TR, Haydel KF, Fujimoto M, Varady A, Killen JD. A randomized controlled trial of culturally tailored dance and reducing screen time to prevent weight gain in low-income African American girls: Stanford GEMS. Arch Pediatr Adolesc Med. 2010 Nov;164(11):995-1004. doi: 10.1001/archpediatrics.2010.197.
PubMed 21041592
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Primary Prevention for At Risk Girls
- ClinicalTrials.gov ID
- NCT00063674
- Acronym / sponsor ID
- T2DPPG (completed)
- Conditions
- Obesity, Diabetes Mellitus, Pre Diabetes
- Keywords
- exercise, eating, dance, health education, obesity prevention, diabetes prevention, children
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- Stanford University
- Study start
- Apr 2003 (actual)
- First posted
- 3 Jul 2003 (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.
Purpose: To evaluate two approaches to prevent obesity and type 2 diabetes in young girls.
The Need: We are experiencing an epidemic of childhood obesity. Rates of obesity have doubled to tripled in the past two decades, with the highest rates among poor and ethnic minority girls. Type 2 diabetes (what used to be called adult-onset diabetes) is now showing up in overweight children, and more children are manifesting precursors of heart disease and stroke.
Our Two Approaches:
- A state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity.
- After-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance.
Participants: Second, third and fourth grade girls and their families will be eligible to participate. All activities are free of charge. To be able to perform a valid evaluation, to be able to accommodate all girls at their own school, and to be fair about which girls receive which program, families who wish to participate will be randomly selected to participate in either one program or the other (nutrition education or dance classes). Each family will participate for two years.
Evaluation: Trained Stanford staff will perform all evaluation procedures with participating families in their own homes at the beginning and every six months. Families will be compensated for their participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education | Active comparator | Behavioral: Nutrition EducationA state-of-the-art nutrition education program with monthly newsletters mailed to girls and their parents and quarterly evening lectures/educational events at school sites, including cooking demonstrations and games to improve nutrition and increase physical activity. |
| After-school dance class | Experimental | Behavioral: After-school dance classAfter-school dance classes held five days per week all year long at school sites from the time school lets out until 6PM. Dance classes will include a 1-1.5 hour supervised homework study hall each day, and emphasize both traditional ethnic dances and popular dance. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| Nutrition Education | Behavioural | Nutrition Education |
| After-school dance class | Behavioural | After-school dance class |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: 24 months
Change in body mass index (BMI) over the 2-year intervention period. BMI was calculated as weight in kilograms divided by height in meters squared.
6 secondary outcomes
Change in Waist Circumference
Time frame: 24 months
Change in Total Cholesterol
Time frame: 24 months
Change in LDL Cholesterol Level
Time frame: 24 months
Change in HDL Cholesterol Level
Time frame: 24 months
Change in Fasting Glucose
Time frame: 24 months
Change in Fasting Insulin
Time frame: 24 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 14 Jul 2026.
- Results publication: PubMed 21041592Robinson TN, Matheson DM, Kraemer HC, Wilson DM, Obarzanek E, Thompson NS, Alhassan S, Spencer TR, Haydel KF, Fujimoto M, Varady A, Killen JD. A randomized controlled trial of culturally tailored dance and reducing screen time to prevent weight gain in low-income African American girls: Stanford GEMS. Arch Pediatr Adolesc Med. 2010 Nov;164(11):995-1004. doi: 10.1001/archpediatrics.2010.197.
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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.
Thomas N Robinson, MD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education and After-school dance class in people with Obesity and Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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?
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 14 Jul 2026. 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?
Change in Body Mass Index (BMI) (time frame: 24 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 NCT00063674, 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 14 Jul 2026.