Overweight/ObesityTTPNCT03573856
Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
A study testing Active Living and Health and Safety in people with Overweight/Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in American Indian youth aged 7-10 years. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight/Obesity
- What is being tested?
- Active Living and Health and Safety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to Sep 2023
- 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
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- self-identify as American Indian
- BMI >=85th percentile for age and sex
- have at least one parent/primary caregiver (parent) willing to actively participate
Who cannot join
- diabetes
- any serious youth/parent health concerns that would interfere with participation
- plans to move out of the area during the study period
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in American Indian youth aged 7-10 years.
Read the detailed description
The objectives of tis study are to rigorously evaluate the effect of Tribal Turning Point (TTP) on diabetes risk factors in Native youth. The investigators will enroll up to 360 youth who are aged 7-10 years, overweight/obese (BMI >85th percentile), self-identify as American Indian, and have >1 parent/primary caregiver willing to actively participate in the program. Within each community, youth will be randomized to the TTP program or a general health and safety control program. The multi-component TTP intervention is a youth-centered adaptation of the Diabetes Prevention Program designed to reduce diabetes risk factors by improving activity and dietary behaviors. Informed by the pediatric weight management literature, the 12-month intervention includes 12 active learning group classes, 7 individual youth/parent motivational interviewing counseling sessions, and community-specific resource toolboxes. In this trial, the investigators will assess the effect of TTP on anthropometric, metabolic, and behavioral risk factors for type 2 diabetes at the end of the intervention (12mo) and after 1 year of follow-up (24mo).
- Conditions
- Overweight/Obesity
- Being tested
- Active Living, Health and Safety
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active LivingBehavioural
Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.
Health and SafetyOther
Participants will be provided with education related to general health and safety topics.
| Study group | Role | What they receive |
|---|---|---|
| Active Living | Active comparator | Three component behavioral intervention consisting of group-based classes, individual motivational interviewing-based sessions, and resource toolbox Receives: Behavioral: Active Living |
| Health and Safety | Placebo comparator | One component health and safety program consisting of group classes Receives: Other: Health and Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from 0 to 12 months in Body Mass Index (BMI)
Measured: 12 months
Change from 0 to 12 months in fasting insulin
Measured: 12 months
Secondary outcomes (4)
Change from 0 to 12 months in BMI z-score
Measured: 12 months
Change from 0 to 12 months in waist circumference
Measured: 12 months
Change from 0 to 12 months in hemoglobin A1c
Measured: 12 months
Change from 0 to 12 months in fasting glucose
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start1 Jul 2018
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight/ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Katherine Sauder, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573856
- Sponsor's protocol ID
- 17-1306
- Other IDs
- R01DK115434
- Acronym
- TTP
- Status last verified
- Nov 2022
- First submitted
- 21 May 2018
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
- ClinicalTrials.gov ID
- NCT03573856
- Acronym / sponsor ID
- TTP / 17-1306
- Conditions
- Overweight/Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 29 Jun 2018 (actual)
- 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 study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in American Indian youth aged 7-10 years.
Detailed description
The objectives of tis study are to rigorously evaluate the effect of Tribal Turning Point (TTP) on diabetes risk factors in Native youth. The investigators will enroll up to 360 youth who are aged 7-10 years, overweight/obese (BMI >85th percentile), self-identify as American Indian, and have >1 parent/primary caregiver willing to actively participate in the program. Within each community, youth will be randomized to the TTP program or a general health and safety control program. The multi-component TTP intervention is a youth-centered adaptation of the Diabetes Prevention Program designed to reduce diabetes risk factors by improving activity and dietary behaviors. Informed by the pediatric weight management literature, the 12-month intervention includes 12 active learning group classes, 7 individual youth/parent motivational interviewing counseling sessions, and community-specific resource toolboxes. In this trial, the investigators will assess the effect of TTP on anthropometric, metabolic, and behavioral risk factors for type 2 diabetes at the end of the intervention (12mo) and after 1 year of follow-up (24mo).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Living | Active comparator | Behavioral: Active LivingThree component behavioral intervention consisting of group-based classes, individual motivational interviewing-based sessions, and resource toolbox |
| Health and Safety | Placebo comparator | Other: Health and SafetyOne component health and safety program consisting of group classes |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- self-identify as American Indian
- BMI >=85th percentile for age and sex
- have at least one parent/primary caregiver (parent) willing to actively participate
Key exclusion criteria (3 listed)
- diabetes
- any serious youth/parent health concerns that would interfere with participation
- plans to move out of the area during the study period
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 |
|---|---|---|
| Active LivingParticipants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living. | Behavioural | Active Living |
| Health and SafetyParticipants will be provided with education related to general health and safety topics. | Other | Health and Safety |
Primary outcome
Change from 0 to 12 months in Body Mass Index (BMI)
Time frame: 12 months
Change from 0 to 12 months in fasting insulin
Time frame: 12 months
4 secondary outcomes
Change from 0 to 12 months in BMI z-score
Time frame: 12 months
Change from 0 to 12 months in waist circumference
Time frame: 12 months
Change from 0 to 12 months in hemoglobin A1c
Time frame: 12 months
Change from 0 to 12 months in fasting glucose
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
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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.
Katherine Sauder, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Living and Health and Safety in people with Overweight/Obesity, run by University of Colorado, Denver 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 3 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: status not confirmed, as of the sponsor's last update on 21 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 from 0 to 12 months in Body Mass Index (BMI) (time frame: 12 months). 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 21 Nov 2022.