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Type 2 DiabetesPhase 3T2DNCT01601574

Weight Loss Study for People With Type 2 Diabetes

A Phase 3 study testing Weight Watchers modified program in people with Type 2 Diabetes and Overweight, run by Medical University of South Carolina at 15 sites 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 study is to determine whether the Weight Watchers program modified for use by people with Type 2 diabetes results in more improvements in blood glucose control relative to a control group receiving standard diabetes counseling. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes, Overweight, Obesity
What is being tested?
Weight Watchers modified program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
563 participants
Where
15 sitesUnited States
Study dates
May 2012to Sep 2014
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant reported diagnosis of Type II diabetes
  • HbA1c between 7%-11% (inclusive)
  • Fasting blood glucose < 240. If a potential participant has a FBG above the inclusion criteria it is acceptable to re-test this potential participant within one week of the original test.
  • BMI 27-50 kg/m2 (inclusive)
  • Age range - 18 - 70 (inclusive)
  • Clearance on medical exam by study physician including EKG
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  • No weight loss over the previous 3 months (5kg loss is acceptable with physician discretion)
  • On stable regimen of all medications (including diabetes) for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
  • All diabetes medications are permitted including insulin.
  • Willing and able to commit to regular physical activity (e.g. walking) five days per week
  • Willingness and ability to make all scheduled appointments required by study protocol
  • Willingness to attend weekly Weight Watchers meetings in the community and to participate in Weight Watchers online program, if so randomized
  • Willing to follow requirements of study protocol
  • Willing and able to provide a valid email address for use in the study
  • Must be able to communicate (oral and written) in English
  • Under the care of a physician for diabetes and willing to give release to contact the MD and request MD's agreement for participant to participate -

Who cannot join

  • Type 1 Diabetes
  • Cardiovascular/Coronary Heart Disease [e.g., MI or CVA within last 6 months, TIA, clinically significant arrhythmias, uncontrolled hypertension (defined as blood pressure over 160/110); physician's discretion may be more conservative]
  • Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode
  • Taking prescription or OTC weight loss medications within last 4 weeks
  • Currently taking other medications that affect weight (e.g., paroxetine, tricyclics, anti-psychotics)
  • Within the last 4 weeks, use of chromium supplements or any nutrition supplements or herbal products claimed to have a weight loss effect. Participants using other non-excluded nutrition supplements or herbal products must agree to continue at their current level of use throughout the study.
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  • Participation in a weight control program within the past 3 months
  • QTc interval >450 msec for males and QTc interval >470 msec for females
  • PHQ-9 total score > 15
  • Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable
  • History of a surgical procedure for weight loss at any time (e.g. gastroplasty, gastric by-pass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve)
  • History of major surgery within three months of enrollment
  • Presence of implanted cardiac defibrillator
  • Orthopedic limitations that would interfere with ability to engage in regular physical activity
  • Gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease
  • Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Persons with successfully resected basal cell carcinoma of the skin may be enrolled if treatment was completed more than 6 months prior to enrollment.
  • History, within the past five years, of clinically diagnosed eating disorders Confidential March 30, 2012 9 including anorexia nervosa or bulimia nervosa.
  • Women who are pregnant, lactating , trying to become pregnant or unwilling to use an effective means of birth control
  • Participation in another clinical trial within 30 days prior to enrollment.
  • Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per drinking day during study participation
  • Current or past drug abuse
  • Participation in trial by another member of household
  • Hypoglycemic Events:
  • Evidence of more than 1 severe hypoglycemic event in the past 12 months, unless the participant's treating physician provides written clearance for participation.
  • Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial -

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Washington Center for Weight Management & Research, Inc The Navy League Building

    Arlington, Virginia, 22201

  • CSRA Partners in Health

    Augusta, Georgia, 30909-6599

  • Diabetes Research and Training Center, University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Center for Nutrition and Preventive Medicine

    Charlotte, North Carolina, 28277

  • Northwestern University Feinberg School

    Chicago, Illinois, 60611

  • Baylor Endocrine Center

    Dallas, Texas, 75246-1906

  • Obesity Clinical Trials Program Duke University Medical Center

    Durham, North Carolina, 27710

  • Scripps Clinical Research

    La Jolla, California, 92037

  • Your Diabetes Endocrine Nutrition Group Inc.

    Mentor, Ohio, 44060

  • Obesity Research Center St. Luke's Roosevelt Hospital Center

    New York, New York, 10025

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • The University of Pennsylvania Center for Weight and Eating Disorders

    Philadelphia, Pennsylvania, 19104

  • Oregon Weight Loss Surgery, LLC

    Portland, Oregon, 97210

  • Oakwell Clinical Research

    San Antonio, Texas, 78218

Other trials in United States

About this study

Official title: Effects on Glycemic Control and Weight of a Modified Commercial Weight Control Program for People With Type 2 Diabetes

The purpose of this study is to determine whether the Weight Watchers program modified for use by people with Type 2 diabetes results in more improvements in blood glucose control relative to a control group receiving standard diabetes counseling.

Being tested
Weight Watchers modified program, Standard Care group
Keywords
Type 2 diabetes, HbA1c, Overweight, Obesity
Medical subject headings
Diabetes Mellitus, Type 2, Overweight, Obesity

What participants receive

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

  • Weight Watchers modified programBehavioural

    Weight Watchers: For people with Type 2 diabetes including (1) weekly standard in-person Weight Watchers meetings, (2) use of the standard Weight Watchers online program and tools, and (3) two scheduled telephone consultations with a Certified Diabetes Educator (CDE) who will assist the participant in tailoring the standard Weight Watchers program to accommodate the participant's diabetes-related status, with additional unlimited phone and email access to CDEs at the participant's request

  • Standard Care groupOther

    One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.

Study groups in NCT01601574
Study groupRoleWhat they receive
Modified Weight Watchers programExperimentalNot described
Receives: Behavioral: Weight Watchers modified program
Standard Diabetes Counseling groupActive comparatorNot described
Receives: Other: Standard Care group

What is being measured

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

  1. Change in HbA1c

    Measured: Baseline and 12 months

Secondary outcomes (8)

  1. Secondary Endpoints

    Change in weight

    Measured: Baseline and 12 months

  2. Secondary Endpoints

    Change in BMI

    Measured: Baseline and 12 months

  3. Secondary Endpoints

    Change in waist circumference

    Measured: Baseline and 12 months

  4. Secondary Endpoints

    Change in fasting blood glucose

    Measured: Baseline and 12 months

  5. Secondary Endpoints

    Change in HOMA

    Measured: Baseline and 12 months

  6. Secondary Endpoints

    Change in cardiovascular risk markers (lipid measures, blood pressure, C-Reactive Protein)

    Measured: Baseline and 12 months

  7. Secondary Endpoints

    Change in diabetes medications.

    Measured: Baseline and 12 months

  8. Secondary Endpoints

    Change in various mental health assessments

    Measured: Baseline and 12 months

Timeline

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

  1. First posted18 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionMay 2014
  4. Study completionSep 2014

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
563 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01601574
Sponsor's protocol ID
WW-MUSC-1201
Acronym
T2D
Status last verified
Mar 2012
First submitted
27 Apr 2012
Last updated
15 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • O'Neil PM, Miller-Kovach K, Tuerk PW, Becker LE, Wadden TA, Fujioka K, Hollander PL, Kushner RF, Timothy Garvey W, Rubino DM, Malcolm RJ, Weiss D, Raum WJ, Salyer JL, Hermayer KL, Rost SL, Veliko JL, Sora ND. Randomized controlled trial of a nationally available weight control program tailored for adults with type 2 diabetes. Obesity (Silver Spring). 2016 Nov;24(11):2269-2277. doi: 10.1002/oby.21616.

    PubMed 27804264

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Weight Watchers modified program in people with Type 2 Diabetes and Overweight, run by Medical University of South Carolina at 15 sites 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 16 inclusion and 25 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 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in HbA1c (time frame: Baseline and 12 months). 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 NCT01601574, which also lists 1 linked publication.

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 15 Oct 2014.

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