ObesityREACH-OUTNCT00723853
REACH-OUT: Chicago Children's Diabetes Prevention Program
A study testing Reach-Out Program, nutritional and exercise program in people with Obesity and Type 2 Diabetes, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate two nutrition and exercise programs in children ages 9-12 who are at risk for developing type 2 diabetes. This study also includes the involvement of parents or guardians who are willing to participate in these programs with the child. Read more about this study
- Who is it for?
- Ages 9 to 65 years
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Reach-Out Program, nutritional and exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2012
- 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 9 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Overweight (>85th percentile BMI for age and gender) African American child age 9-12 with family history of type 2 diabetes in a first or second degree relative. Parents are secondary subjects.
Who cannot join
- Inability to give informed consent or unwillingness to be randomized
- Prior diagnosis of diabetes in the child planning to participate
- Pregnancy (women who become pregnant during the study will be omitted from the analysis. Pregnant women will not participate in the exercise sessions).
- Uncontrolled hypertension (SBP> 160 or DBP>100) (JNC V, 1993)
- Uncontrolled dyslipidemia by NCEP III criteria (NCEP, 2001)
- Evidence of significant cardiovascular, pulmonary disease, or other serious illness
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- Evidence of alcohol or drug abuse (identified by self-report)
- Musculoskeletal disease serious enough to prevent participation in exercise sessions
- Known or suspected major psychiatric disorder
- Inability to participate in aerobic exercise activities
- Inability to comply with a calorie or fat restricted diet
- Age over 65 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago GCRC (General Clinical Research Center)
Chicago, Illinois, 60637
About this study
The purpose of this research study is to evaluate two nutrition and exercise programs in children ages 9-12 who are at risk for developing type 2 diabetes. This study also includes the involvement of parents or guardians who are willing to participate in these programs with the child.
Read the detailed description
This is a prevention study that evaluates a community-based, family oriented intervention called Reach-Out. The University of Chicago will partner with community organizations including the Women, Infants and Children [WIC] Clinic at the Chicago Department of Public Health Roseland Clinic, South Side YMCA, the Chicago Park District and the Southside Faith-Based Wellness Network of churches to deliver the intervention. Families will be recruited from the high risk population of patients in the University of Chicago Diabetes database and the Chicago Childhood Diabetes Registry; and La Rabida Children's Hospital; and from the broader south side African-American community ("outreach" population). Families will be randomized to behavioral intervention (Reach-Out Program, hands on nutrition and exercise) or control group(Reach-In Program, standard of care consultation).
All who participate in this study will be seen at the University of Chicago GCRC (General Clinical Research Center). They will be asked to come in at the beginning of the study, after 14 weeks, afer 1 year and after 2 years.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Reach-Out Program, nutritional and exercise program, Reach-In Program, standard of care
- Keywords
- Obesity, Type 2 diabetes, African American children, African American youth, Community based, Family oriented, Obesity & Risk of type 2 diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reach-Out Program, nutritional and exercise programBehavioural
This group will participate in the Reach-Out nutritional and exercise program. This includes 14 weekly, group sessions involving both parents and children.
During these sessions, participants will receive hands-on education regarding food and exercise habits. Sample nutrition activities include learning to read nutrition labels on foods, a tour of a grocery store and practicing a recipe substituting low fat for high fat ingredients. Exercise activities involve physical activities appropriate for children and adults, respectively. Session leaders will help subjects set personal goals in the areas of nutrition and physical activity, and follow up on subjects' progress each week at sessions and with telephone calls between sessions. At the end of the 14-week program, subjects will be asked to attend four bi-monthly and 18 monthly follow-up sessions in which subjects will continue to meet as a group to work on goals in the areas of nutrition and exercise.
Reach-In Program, standard of careBehavioural
This group will received standard medical care for their health condition. This includes meeting individually with a dietician to learn about diet, exercise and diabetes. This also includes developing an individualized meal plan.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Reach-Out Program, Nutritional and Exercise Intervention Receives: Behavioral: Reach-Out Program, nutritional and exercise program |
| Group 2 | Active comparator | Reach-In Program, Standard of Care Receives: Behavioral: Reach-Out Program, nutritional and exercise program; Behavioral: Reach-In Program, standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
Measured: 14 weeks, 1 year, 2 years
Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)
Measured: 14 weeks, 1 year, 2 years
Secondary outcomes (2)
Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)
Measured: 14 weeks, 1 year, 2 years
Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)
Measured: At two weekly meetings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Burnet, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723853
- Sponsor's protocol ID
- 11113B
- Acronym
- REACH-OUT
- Status last verified
- Sep 2013
- First submitted
- 25 Jul 2008
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACH-OUT: Chicago Children's Diabetes Prevention Program
- ClinicalTrials.gov ID
- NCT00723853
- Acronym / sponsor ID
- REACH-OUT / 11113B
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Obesity, Type 2 diabetes, African American children, African American youth, Community based, Family oriented, Obesity & Risk of type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Jul 2008 (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 research study is to evaluate two nutrition and exercise programs in children ages 9-12 who are at risk for developing type 2 diabetes. This study also includes the involvement of parents or guardians who are willing to participate in these programs with the child.
Detailed description
This is a prevention study that evaluates a community-based, family oriented intervention called Reach-Out. The University of Chicago will partner with community organizations including the Women, Infants and Children [WIC] Clinic at the Chicago Department of Public Health Roseland Clinic, South Side YMCA, the Chicago Park District and the Southside Faith-Based Wellness Network of churches to deliver the intervention. Families will be recruited from the high risk population of patients in the University of Chicago Diabetes database and the Chicago Childhood Diabetes Registry; and La Rabida Children's Hospital; and from the broader south side African-American community ("outreach" population). Families will be randomized to behavioral intervention (Reach-Out Program, hands on nutrition and exercise) or control group(Reach-In Program, standard of care consultation).
All who participate in this study will be seen at the University of Chicago GCRC (General Clinical Research Center). They will be asked to come in at the beginning of the study, after 14 weeks, afer 1 year and after 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Reach-Out Program, nutritional and exercise programReach-Out Program, Nutritional and Exercise Intervention |
| Group 2 | Active comparator | Behavioral: Reach-Out Program, nutritional and exercise program, Behavioral: Reach-In Program, standard of careReach-In Program, Standard of Care |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Overweight (>85th percentile BMI for age and gender) African American child age 9-12 with family history of type 2 diabetes in a first or second degree relative. Parents are secondary subjects.
Key exclusion criteria (12 listed)
- Inability to give informed consent or unwillingness to be randomized
- Prior diagnosis of diabetes in the child planning to participate
- Pregnancy (women who become pregnant during the study will be omitted from the analysis. Pregnant women will not participate in the exercise sessions).
- Uncontrolled hypertension (SBP> 160 or DBP>100) (JNC V, 1993)
- Uncontrolled dyslipidemia by NCEP III criteria (NCEP, 2001)
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 |
|---|---|---|
| Reach-Out Program, nutritional and exercise programThis group will participate in the Reach-Out nutritional and exercise program. This includes 14 weekly, group sessions involving both parents and children. During these sessions, participants will receive hands-on education regarding food and exercise habits. Sample nutrition activities include learning to read nutrition labels on foods, a tour of a grocery store and practicing a recipe substituting low fat for high fat ingredients. Exercise activities involve physical activities appropriate for children and adults, respectively. Session leaders will help subjects set personal goals in the areas of nutrition and physical activity, and follow up on subjects' progress each week at sessions and with telephone calls between sessions. At the end of the 14-week program, subjects will be asked to attend four bi-monthly and 18 monthly follow-up sessions in which subjects will continue to meet as a group to work on goals in the areas of nutrition and exercise. | Behavioural | Group 1, Group 2 |
| Reach-In Program, standard of careThis group will received standard medical care for their health condition. This includes meeting individually with a dietician to learn about diet, exercise and diabetes. This also includes developing an individualized meal plan. | Behavioural | Group 2 |
Primary outcome
Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE)
Time frame: 14 weeks, 1 year, 2 years
Biochemical markers (glucose tolerance, lipid panel, insulin, hemoglobin A-1-C)
Time frame: 14 weeks, 1 year, 2 years
2 secondary outcomes
Behavior measurements (food, physical activity, weigh loss, stress, support and television viewing)
Time frame: 14 weeks, 1 year, 2 years
Cost Assessment (costs incurred to attend meetings, eat healthier, exercise more)
Time frame: At two weekly meetings
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 5 Sep 2013.
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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.
Deborah Burnet, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reach-Out Program, nutritional and exercise program in people with Obesity and Type 2 Diabetes, run by University of Chicago 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 1 inclusion and 12 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 5 Sep 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?
Measure of body habitus (height, weight, waist and hip circumference, body fat by BIE) (time frame: 14 weeks, 1 year, 2 years). The study lists 2 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 5 Sep 2013.