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The HEALTHY study is a randomized prevention trial that investigated the effectiveness of an integrated intervention in middle schools that aimed to moderate risk for type 2 diabetes in children. The trial was conducted at 7 field centers in 42 middle schools, randomly assigned to intervention or control. Student recruitment and baseline data collection occurred during in the first semester of 6th grade (2006); the intervention was implemented the following semester (2007) and continued through 8th grade (2007-2009). For schools that received intervention, the program consisted of four integrated components targeting nutrition, physical education, behavior change initiatives, and educational communications activities that were designed to impact the environment and lifestyle choices of middle school children. The intervention was implemented either school-wide or grade-wide, so all students were exposed; those who provided appropriate informed consent participated in data collection and evaluation. The primary outcome measure was the combined prevalence of overweight and obesity (BMI ≥ 85th percentile). The study found that the combined prevalence of overweight and obesity decreased in both intervention and control schools, with no significant difference between school groups. However, the intervention did result in significantly greater reductions in various indexes of adiposity, including obesity.
Detailed information about the HEALTHY study, including the protocol, intervention materials, and publications, is available at www.healthystudy.org.
The main goal of the HEALTHY study was to assess the effects of a school-based intervention program on risk factors for diabetes among middle-school aged children whose race/ethnicity and socioeconomic status placed them at high risk for obesity and type 2 diabetes. In addition to the primary objective of affecting risk for type 2 diabetes, major secondary objectives included further understanding and characterization of the etiology of risk of type 2 diabetes in this age group; evaluating the ability of the intervention to influence lifestyle changes and choices both in and out of school; determining the cost-effectiveness of the intervention; and comparing academic performance, attendance, and comportment in intervention versus control schools.
The primary outcome measure was the combined prevalence of overweight and obesity (BMI ≥ 85th percentile). Secondary outcome measures included prevalence of obesity (BMI ≥ 95th percentile), BMI z score, and continuous and categorical measurements of waist circumference, fasting glucose level, and fasting insulin level.
Inclusion criteria for schools eligible to participate in the study included:
- A student body at least 50% minority and at least 50% eligible for free or reduced lunch
- Annual school-wide attrition from all causes ≤ 25%
- Expected cohort size of at end of study of at least 50 per school (determined by applying 50% anticipated enrollment rate and annual school-wide attrition rate over 3 years)
Students were eligible to participate if they met the following criteria:
- Ability to participate in the school’s standard PE program
- No diagnosis of diabetes
- Informed consent from both parent/guardian and student
The combined prevalence of overweight and obesity decreased in both intervention and control schools, with no significant difference between school groups. However, intervention schools had greater reductions in various indexes of adiposity, including BMI z score, percentage of students with waist circumference at or above the 90th percentile, and fasting insulin levels. These changes may reduce the risk of childhood-onset type 2 diabetes.
Nutrition, Diabetes, Multidisciplinary Research, Obesity
Interventional
42
2006-08
2011-02
Obesity Disorder, Prediabetes Syndrome, Type 2 Diabetes Mellitus
Risk Factors, Childhood-Onset Type 2 Diabetes, Socioeconomic Status, Middle School, Integrated Program of Nutrition, Insulin Level, BMI Z Score, Adiposity, Education, Physical Education, Waist Circumference, Glucose Level
Division of Diabetes, Endocrinology, and Metabolic Diseases
Document Name | Description | Document Type | File Format | Compliance | Download |
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- Use is allowed for health, medical, or biomedical research purposes
Document Name | Description | Document Type | File Format |
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Dataset Name | Description | # of Records | # of Variables | File Format(s) |
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Health Screening Measures | Corresponds with ST3 Health Screening Repository.pdf form, which was used to collect demographic information about the participants, their anthropometric measures, and blood pressure readings. This form was collected at baseline (6th grade), interim (7th grade), and end of study (8th grade). Variable GRADE is 6 for baseline, 7 for interim, and 8 for end of study. At baseline and end of study a fasting blood draw was performed. When the participant checked in, they were probed about their consumption of food or drinks since midnight. If fasting was not confirmed they were rescheduled to return another day. For question 5, if the student was a member of the longitudinal cohort, all responses were automatically. | 17896 | csv (1.59 MB); sas7bdat (3.89 MB) | |
2-Day Self-Administered Physical Activity Checklist (SAPAC) | Corresponds with ST6 SAPAC Repository.pdf form, which was used to collect information about physical activities and sedentary behaviors for each participant. The form was administered at baseline (6th grade) and end of study (8th grade). Variable GRADE is 6 for baseline and 8 for end of study. The questionnaire was administered on a Wednesday, Thursday or Friday in order for the previous two days to both be ‘regular’ school days. This was done in an effort to get an appropriate snapshot of regular behaviors for each participant and to have the greatest likelihood of correct recall. The questionnaire was administered in a group setting with the participant completing their own forms. The first page of the form captures activities preformed yesterday. If only one physical activity and/or other activity was completed then only one page is needed. However, if additional physical or other activities were completed then additional pages are needed (one for each physical activity/other activity combination). Time spent doing each physical activity before, during and after school is reported in minutes as well as the amount of that time spent breathing hard. For the other activities (sedentary behaviors) the time spent in minutes is reported before and after school only. The second page of the form repeats the above for the day before yesterday. | 205785 | csv (6.75 MB); sas7bdat (19.15 MB) | |
Health Thermometer | Corresponds with ST8 Health Thermometer Repository.pdf form, which was used to collect information about the quality of life for each participant. The form was administered at baseline (6th grade), interim (7th grade) and end of study (8th grade). Variable GRADE is 6 for baseline, 7 for interim, and 8 for end of study. The questionnaire was completed by each participant in a self-report format without an interviewer. A member of the study staff was available if the participant had questions while completing the form. Every attempt was made to do a quick review of forms before accepting them from the student, however, on a few occasions forms were turned in with multiple lines crossing the thermometer. In these cases the smaller number was entered into the database. | 17940 | csv (404.3 KB); sas7bdat (713 KB) | |
20-Meter Shuttle Run | Corresponds with ST9 20 Meter Shuttle Test Repository.pdf form, which was used to collect information about the fitness level of each participant. The form was administered at baseline (6th grade) and end of study (8th grade). Variable GRADE is 6 for baseline and 8 for end of study. The 20-meter shuttle test or PACER was administered using standardized guidelines. Once the participant could not complete their second lap in the allotted time, the lap number for the previous lap was recorded for that participant. | 11987 | csv (267.93 KB); sas7bdat (481 KB) | |
Student Self-Administered Pubertal Development Scale | Corresponds with ST4 Pubertal Development Scale Repository.pdf form, which was used to collect information about pubertal development for each participant. The form was administered at baseline (6th grade) and end of study (8th grade). Variable GRADE is 6 for baseline and 8 for end of study. The questionnaire is gender specific, but a few questions pertain to both boys and girls. Each label in the database indicates which gender or genders the response are for as well as which question for that gender. In some cases the question numbers are the same for both boys and girls, but in others the question numbers are different. The questionnaire was completed by each participant in a self-report format without an interviewer on a PDA. A member of the study staff was available if the participant had questions while completing the form. | 12425 | csv (432.62 KB); sas7bdat (1.25 MB) | |
Laboratory Data | HEALTHY data CBL includes the laboratory results from baseline (6th grade) and end of study (8th grade) health screening. The laboratory results are outlined in the table below and measured at both baseline and end of study. Not all participants had successful blood draws at either or both time points. All blood draws were conducted fasting. There is no form associated with the CBL data; a list of variables is provided in Repository Documentation | 12360 | csv (574.95 KB); sas7bdat (1.16 MB) | |
Food Frequency Responses and Nutrient Data | HEALTHY data ST5 includes the responses to a modified food frequency questionnaire administered at baseline (6th grade) and end of study (8th grade). The questionnaire was self-administered with study staff available if the participant had questions. Based on the participant’s responses, nutrient analysis was conducted by Block Dietary Data Systems in Berkley, CA. The actual questionnaire is not available for release. Corresponds with the ST5 Block Food Frequency Questionnaire; the form is not provided due to copyright restrictions. Instead, a list of variables is provided in <Repository Documentation.pdf> | 11651 | csv (14.48 MB); sas7bdat (36.47 MB) | |
Randomization Assignments | Includes one record for each school indicating the randomization assignment for that particular school. If assign=0 then the school was randomized to control. If assign=1 then the school was randomized to intervention | 42 | csv (230 B); sas7bdat (5 KB) | |
Health Utilities Index | Corresponds with ST7 Health Utilities Index Repository.pdf form, which was used to collect information about the quality of life for each participant. The form was administered at baseline (6th grade), interim (7th grade) and end of study (8th grade). Variable GRADE is 6 for baseline, 7 for interim, and 8 for end of study. The questionnaire was completed by each participant in a self-report format without an interviewer on a PDA. A member of the study staff was available if the participant had questions while completing the form. | 17623 | csv (1.27 MB); sas7bdat (6 MB) | |
Family Information | Corresponds with ST2 Family Information Repository.pdf, which was used to collect information about the participant’s family regarding head of household education and history of diabetes diagnosis in family members. This form was collected at both baseline (6th grade) and end of study (8th grade). Variable GRADE is 6 for baseline and 8 for end of study. For the family history response, if any family member in the classification (mother, father, or sibling for first degree family members and grandmother, grandfather, or aunt/uncle for second degree family members) was indicated with a positive diagnosis then the overall response was coded as YES. If all members of the grouping were not reported to have a diagnosis of diabetes then the overall response was coded as NO. However, if no member reported having diabetes but at least one member of the grouping had a Don’t Know response then the overall response was coded as I DON’T KNOW. | 11218 | csv (306.55 KB); sas7bdat (713 KB) |
Specimen | Count |
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| Serum | 66608 |