PrediabetesNCT00438126
Family-Centered Diabetes Project - Sharing Wisdom
A study testing A lifestyle educational program in people with Prediabetes and Metabolic Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Metabolic Syndrome, Overweight
- What is being tested?
- A lifestyle educational program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to May 2006
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Indian women
- Aged 18-40 years
- Living in Albuquerque area
- Not having diabetes
Who cannot join
- Pregnancy
- Planning to become pregnant within 2 years
- Diagnosed with diabetes fasting blood glucose > 126 planning to move out of town in next 2 years
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico School of Medicine
Albuquerque, New Mexico, 87110
About this study
This is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women
Read the detailed description
Two hundred American Indian women aged 18 to 40 years were recruited from a large Southwest city to participate in a type 2 diabetes prevention intervention. Half of the women were randomized to participated in the educational intervention and half were assigned to a delayed intervention. Measures were obtained at baseline, 6-months,12-months and 18-months.
- Conditions
- Prediabetes, Metabolic Syndrome, Overweight, Obesity
- Being tested
- A lifestyle educational program
- Keywords
- diabetes, Prevention, American Indian
- Medical subject headings
- Prediabetic State, Metabolic Syndrome, Overweight, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A lifestyle educational programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
decreased dietary fat intake
increased vegetable consumption
increased self-reported leisure physical activity
Secondary outcomes (8)
fasting glucose
HOMA
serum free insulin
Body Mass Index
waist circumference
decreased dietary intake of total sugar
decreased time watching television
resting blood pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startJan 2002
- Study completionMay 2006
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 PrediabetesStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Carla J Herman, MD, MPH, Principal investigator, Univeristy of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438126
- Sponsor's protocol ID
- DK47096 (completed)
- Status last verified
- Mar 2010
- First submitted
- 20 Feb 2007
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Willging CE, Helitzer D, Thompson, J 'Sharing Wisdom': Lessons learned during the development of a diabetes prevention intervention for urban American Indian women Evaluation and Program Planning 29 (2006) 130-140
Helitzer D, Peterson AB, Thompson J, Fluder S. Development of a planning and evaluation methodology for assessing the contribution of theory to a diabetes prevention lifestyle intervention. Health Promot Pract. 2008 Oct;9(4):404-14. doi: 10.1177/1524839906289076. Epub 2006 Jul 21.
PubMed 16861598Thompson JL, Allen P, Helitzer DL, Qualls C, Whyte AN, Wolfe VK, Herman CJ. Reducing diabetes risk in American Indian women. Am J Prev Med. 2008 Mar;34(3):192-201. doi: 10.1016/j.amepre.2007.11.014.
PubMed 18312806
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Centered Diabetes Project - Sharing Wisdom
- ClinicalTrials.gov ID
- NCT00438126
- Acronym / sponsor ID
- DK47096 (completed)
- Conditions
- Prediabetes, Metabolic Syndrome, Overweight, Obesity
- Keywords
- diabetes, Prevention, American Indian
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Jan 2002
- Study completion
- May 2006
- First posted
- 21 Feb 2007 (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 is a randomized trial of an educational intervention to reduce the risk of diabetes among urban American Indian women
Detailed description
Two hundred American Indian women aged 18 to 40 years were recruited from a large Southwest city to participate in a type 2 diabetes prevention intervention. Half of the women were randomized to participated in the educational intervention and half were assigned to a delayed intervention. Measures were obtained at baseline, 6-months,12-months and 18-months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Indian women
- Aged 18-40 years
- Living in Albuquerque area
- Not having diabetes
Key exclusion criteria (3 listed)
- Pregnancy
- Planning to become pregnant within 2 years
- Diagnosed with diabetes fasting blood glucose > 126 planning to move out of town in next 2 years
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 |
|---|---|---|
| A lifestyle educational program | Behavioural | – |
Primary outcome
decreased dietary fat intake
increased vegetable consumption
increased self-reported leisure physical activity
8 secondary outcomes
fasting glucose
HOMA
serum free insulin
Body Mass Index
waist circumference
decreased dietary intake of total sugar
decreased time watching television
resting blood pressure
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 2 Mar 2010.
- BackgroundWillging CE, Helitzer D, Thompson, J 'Sharing Wisdom': Lessons learned during the development of a diabetes prevention intervention for urban American Indian women Evaluation and Program Planning 29 (2006) 130-140
- Background: PubMed 16861598Helitzer D, Peterson AB, Thompson J, Fluder S. Development of a planning and evaluation methodology for assessing the contribution of theory to a diabetes prevention lifestyle intervention. Health Promot Pract. 2008 Oct;9(4):404-14. doi: 10.1177/1524839906289076. Epub 2006 Jul 21.
- Derived from this study: PubMed 18312806Thompson JL, Allen P, Helitzer DL, Qualls C, Whyte AN, Wolfe VK, Herman CJ. Reducing diabetes risk in American Indian women. Am J Prev Med. 2008 Mar;34(3):192-201. doi: 10.1016/j.amepre.2007.11.014.
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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.
Carla J Herman, MD, MPH principal investigator
Univeristy of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A lifestyle educational program in people with Prediabetes and Metabolic Syndrome, 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?
The sponsor lists 4 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: finished, as of the sponsor's last update on 2 Mar 2010. 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?
decreased dietary fat intake. The study lists 3 primary outcomes in all. 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 NCT00438126, 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 2 Mar 2010; AzTrials last refreshed its copy on 2 Nov 2026.