Type 2 Diabetes MellitusNCT00848757

Changing Lifestyles for Better Health

A study testing Intensive Lifestyle Intervention in people with Type 2 Diabetes Mellitus, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this research collaboration between Dr. William Tamborlane, Deputy Directory of the Yale Center for Clinical Investigation (YCCI) and Fair Haven Community Health Center's (FHCHC) Diabetes Prevention Team is to determine the efficacy of an intensive life-style intervention (ILI) program that has been… Read more about this study

Who is it for?: Ages 18 to 55 years, women only
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Intensive Lifestyle Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Jul 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
Women only
No healthy volunteers
Adult

Who may be able to join

In order to be eligible for this study, the following criteria must be met:
Subjects must be willing to travel to the clinic for all regularly scheduled study visits, and to the lifestyle intervention program site for the ILI (the John Martinez School).
Subjects must have had a 2 hour 75 gram Oral Glucose Tolerance Test (OGTT) with fasting glucose between 100 and 126, or 2 hour glucose between 140 and 200 mg/dl in order to participate in this study within the 4 months prior to enrollment.
Willingness to undergo fasting blood testing: HOMA-IR, fasting lipid profile (including total cholesterol, HDL, LDL cholesterol and triglycerides) at the beginning of the study (if not previously obtained with the OGTT) and repeated at 12 months.
Subjects must have no medical contraindications to exercise or dieting.

Who cannot join

Subjects will be excluded from the study if they have diabetes or other serious medical or psychiatric condition that would preclude participation in the ILI program.
Subjects will be excluded if they are taking medications that potentially cause significant weight gain or weight loss (including prescription medication, over the counter medication, or herbal supplements)..
Women who are pregnant or planning to become pregnant will not be enrolled in this study.
Any behavioral or psychosocial issue that will interfere with the subject's completion of the program, including an eating disorder will prohibit subjects from participating in this study.
Subjects cannot participate if they have concurrent membership in a comprehensive weight management program.

Trial locations and contacts

1 site in 1 country.

United States1 site

Fair Haven Community Health Center
New Haven, Connecticut, 06513

Other trials in United States

About this study

Official title: Changing Lifestyles for Better Health: A Model Program for Community Health Centers

Read the detailed description

This project is a clinical outcome study that merges the expertise of a senior Yale clinical investigator, the clinical and translational research resources of YCCI, the clinical and community expertise of the FHCHC Diabetes Team, and the high-need patient population of FHCHC. In addition to determining the efficacy and cost-effectiveness of an ILI for diabetes prevention in an inner-city community health center setting, this project will evaluate the effectiveness of pooling academic expertise with direct clinical services to disadvantaged, at-risk populations.

Conditions: Type 2 Diabetes Mellitus
Being tested: Intensive Lifestyle Intervention
Keywords: Diabetes, Lifestyle Intervention
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intensive Lifestyle InterventionBehavioural
Women with pre-diabetes randomized to the ILI will attend an intensive 12-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.

Study groups in NCT00848757
Study group	Role	What they receive
Intensive Life-Style Counseling	Experimental	Women with pre-diabetes randomized to the ILI will attend an intensive 12-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the Diabetes Prevention Program (DPP) "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Receives: Behavioral: Intensive Lifestyle Intervention
Usual Care Control	No intervention	Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Weight
The change is weight is reported from baseline to 12 months.
Measured: Baseline and 12 Months
Change in BMI
The change in BMI is reported from baseline to 12 months.
Measured: Baseline and 12 Months
Change in Percent Body Fat
Change in percent body fat is reported from baseline to 12 months. Body composition by body fat analyzer (TBF-300; Tanita,Arlington Heights, IL) was used.
Measured: Baseline and 12 Months
Change in Waist Circumference
Change in waist circumference was measured from baseline to 12 months
Measured: Baseline and 12 Months
Change in Blood Pressure
Change in blood pressure was measured from baseline to 12 months
Measured: Baseline and 12 Months

Secondary outcomes (1)

Physical Activity Levels (Self-reported)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Jul 2014

First posted20 Feb 2009 (estimated)
Study startMar 2009
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00848757
Sponsor's protocol ID: 0903004817
Status last verified: Apr 2022
First submitted: 18 Feb 2009
Last updated: 4 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Changing Lifestyles for Better Health: A Model Program for Community Health Centers
ClinicalTrials.gov ID: NCT00848757
Acronym / sponsor ID: 0903004817
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes, Lifestyle Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Donaghue Medical Research Foundation
Study start: Mar 2009
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 20 Feb 2009 (estimated)
Results: Posted 17 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intensive Life-Style Counseling	Experimental	Behavioral: Intensive Lifestyle InterventionWomen with pre-diabetes randomized to the ILI will attend an intensive 12-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the Diabetes Prevention Program (DPP) "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.
Usual Care Control	No intervention	–Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate.

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Subjects must be willing to travel to the clinic for all regularly scheduled study visits, and to the lifestyle intervention program site for the ILI (the John Martinez School).
Subjects must have had a 2 hour 75 gram Oral Glucose Tolerance Test (OGTT) with fasting glucose between 100 and 126, or 2 hour glucose between 140 and 200 mg/dl in order to participate in this study within the 4 months prior to enrollment.
Willingness to undergo fasting blood testing: HOMA-IR, fasting lipid profile (including total cholesterol, HDL, LDL cholesterol and triglycerides) at the beginning of the study (if not previously obtained with the OGTT) and repeated at 12 months.
Subjects must have no medical contraindications to exercise or dieting.

Key exclusion criteria (5 listed)

Subjects will be excluded from the study if they have diabetes or other serious medical or psychiatric condition that would preclude participation in the ILI program.
Subjects will be excluded if they are taking medications that potentially cause significant weight gain or weight loss (including prescription medication, over the counter medication, or herbal supplements)..
Women who are pregnant or planning to become pregnant will not be enrolled in this study.
Any behavioral or psychosocial issue that will interfere with the subject's completion of the program, including an eating disorder will prohibit subjects from participating in this study.
Subjects cannot participate if they have concurrent membership in a comprehensive weight management program.

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
Intensive Lifestyle InterventionWomen with pre-diabetes randomized to the ILI will attend an intensive 12-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population.	Behavioural	Intensive Life-Style Counseling

Primary outcome

Change in Weight
Time frame: Baseline and 12 Months
The change is weight is reported from baseline to 12 months.
Change in BMI
Time frame: Baseline and 12 Months
The change in BMI is reported from baseline to 12 months.
Change in Percent Body Fat
Time frame: Baseline and 12 Months
Change in percent body fat is reported from baseline to 12 months. Body composition by body fat analyzer (TBF-300; Tanita,Arlington Heights, IL) was used.
Change in Waist Circumference
Time frame: Baseline and 12 Months
Change in waist circumference was measured from baseline to 12 months
Change in Blood Pressure
Time frame: Baseline and 12 Months
Change in blood pressure was measured from baseline to 12 months

1 secondary outcome

Physical Activity Levels (Self-reported)
Time frame: 12 months

Results and safety

Results posted to the registry on 17 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intensive Lifestyle Intervention (ILI)	65	61
Usual Care Control	65	61

Primary outcome: Change in Weight

Time frame: Baseline and 12 Months. Least squares mean (95% Confidence Interval). Unit: kg

Measure	Intensive Lifestyle Intervention (ILI) n = 61	Usual Care Control n = 61
Value	-3.8 (-4.6 to -3.0)	1.4 (.6 to 2.2)

Primary outcome: Change in BMI

Time frame: Baseline and 12 Months. Least squares mean (95% Confidence Interval). Unit: kg/m^2

Measure	Intensive Lifestyle Intervention (ILI) n = 61	Usual Care Control n = 61
Value	-1.6 (-2 to -1.3)	0.6 (0.2 to 0.9)

Primary outcome: Change in Percent Body Fat

Time frame: Baseline and 12 Months. Least squares mean (95% Confidence Interval). Unit: percent of body fat

Measure	Intensive Lifestyle Intervention (ILI) n = 61	Usual Care Control n = 61
Value	-1.9 (-2.9 to -1.0)	0.4 (-0.7 to 1.4)

Primary outcome: Change in Waist Circumference

Time frame: Baseline and 12 Months. Least squares mean (95% Confidence Interval). Unit: cm

Measure	Intensive Lifestyle Intervention (ILI) n = 61	Usual Care Control n = 61
Value	-3.3 (-5.2 to -1.4)	-0.2 (-2.1 to 1.7)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care Control	0 of 61 (0%)	0 of 61 (0%)	0 of 61
Intensive Lifestyle Intervention (ILI)	0 of 61 (0%)	0 of 61 (0%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intensive Lifestyle Intervention in people with Type 2 Diabetes Mellitus, run by Yale University 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 5 inclusion and 5 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 4 May 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. 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?

Yes. Results are posted in the registry (first posted 17 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Weight (time frame: Baseline and 12 Months). The study lists 5 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 NCT00848757.

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 4 May 2022.