Assessing the Effectiveness of a Weight Watchers-based Lifestyle Intervention for the Primary Prevention of Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Weight Watchers International
Indiana CTSI
National Diabetes Education Program
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT02000024
First received: November 26, 2013
Last updated: NA
Last verified: November 2013
History: No changes posted

November 26, 2013
November 26, 2013
December 2011
April 2015   (final data collection date for primary outcome measure)
Changes in weight [ Time Frame: 6, 12, 19 and 24 months from baseline ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Changes in A1c [ Time Frame: 6, 12, 19 and 24 months from baseline ] [ Designated as safety issue: No ]
  • Changes in systolic blood pressure [ Time Frame: 6, 12, 19 and 24 months from baseline ] [ Designated as safety issue: No ]
  • Changes in total cholesterol [ Time Frame: 6, 12, 19 and 24 months from baseline ] [ Designated as safety issue: No ]
  • Changes in HDL-cholesterol [ Time Frame: 6, 12, 19 and 24 months from baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Assessing the Effectiveness of a Weight Watchers-based Lifestyle Intervention for the Primary Prevention of Type 2 Diabetes
Assessing the Effectiveness of a Weight Watchers-based Lifestyle Intervention for the Primary Prevention of Type 2 Diabetes

This study is a randomized pilot study to assess the applicability of the Weight Watchers model for lifestyle modification to the primary prevention of type 2 diabetes. The approach developed by Weight Watchers to achieve weight loss is based on similar nutritional principals and techniques used in the Diabetes Prevention Program (DPP) lifestyle intervention; monitoring food intake, exercising calorie control, setting modest weight loss goals and using physical activity.

In the proposed study, the standard Weight Watchers program will serve as the base curriculum. Persons with increased risk for developing type 2 diabetes will be exposed to an initial "orientation session" designed to frame the rationale for participation in the program and to encourage attendance to a core series of sessions. This orientation session will reinforce the pre-diabetes status of participants and present the rationale for lifestyle modification as a means to reduce diabetes risk. In addition, this session will highlight the recommended sessions and topics that are needed to help reduce risk. In many respects it mirrors the curriculum content used in the DPP with regards to themes and specific topics. There are significant differences, however, between the two approaches that warrant investigation. Weight Watchers uses a point system to help users select appropriate foods. This system is less focused on fat gram control as a central theme than was the case with the DPP. More importantly, it uses an "open visit" system in which users get a core set of materials for home review that is then reviewed in facilitated group sessions. In this regard, the group session content is not configured as a sequential series of sessions delivered in a specific order, as was the case with the DPP. Moreover, participants can rejoin groups at any time that they choose. Weight Watchers also provides a sophisticated set of support materials online, using both phone apps (to help users track food consumption and "points" used) and a website program. The open attendance feature and the availability of online support should, in theory, facilitate long-term adherence.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Prediabetes
  • Gestational Diabetes Mellitus
  • Obesity
  • Behavioral: Weight Watchers
    The standard Weight Watchers program will serve as the base curriculum. Persons with increased risk for developing type 2 diabetes will be exposed to an initial "orientation session" designed to frame the rationale for participation in the program and to encourage attendance to a core series of sessions. This orientation session will reinforce the pre-diabetes status of participants and present the rationale for lifestyle modification as a means to reduce diabetes risk. In addition, this session will highlight the recommended sessions and topics that are needed to help reduce risk.
  • Behavioral: National Diabetes Education Program
  • Experimental: Lifestyle coaching
    The existing Weight Watchers lifestyle modification program including the online support tools.
    Intervention: Behavioral: Weight Watchers
  • Active Comparator: Lifestyle counseling
    Brief advice regarding risk factors and strategies to reduce them by lifestyle modification guided by National Diabetes Education Program (NDEP) materials.
    Interventions:
    • Behavioral: Weight Watchers
    • Behavioral: National Diabetes Education Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
225
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Persons age 18 and over
  • Determination of BMI ≥ 24 kg/m2; persons of Asian Descent BMI > 23 kg/m2
  • Completion of the 7-item ADA Diabetes Risk Assessment and an ADA risk score > 5
  • Persons with a value of 100mg/dl or greater will confer eligibility from a single drop of whole blood obtained by finger stick to assess casual capillary blood glucose (CCBG) concentration using One-Touch Ultra handheld glucometer.
  • Persons at high-risk for Impaired Glucose Tolerance (IGT), having an ADA Risk Score >5 and CCBG 110-199 mg/dl or an A1c >5.7%and < 6.5%.
  • Women with a self-reported history of gestational diabetes with an A1c <6.5% and/or CCBG <199 mg/dl

Exclusion Criteria:

  • Persons under the age of 18
  • Persons with no evidence of pre-diabetes.
  • Persons who are pregnant or planning to become pregnant.
  • Person unable or unwilling to provide consent.
  • Screening attendees who have a known condition that could alter glucose metabolism (e.g. pregnancy; known diabetes; antipsychotic or steroid medications; certain diseases or other conditions including Cushing's syndrome, acromegaly, pheochromocytoma, chronic pancreatitis, or HIV.)
  • Heart attack, stroke or transient ischemic attack (TIA) in the past 6 months.
  • Uncontrolled hypertension: systolic > 180mmHg or diastolic >105mmHg.
  • Persons receiving treatment for cancer (excluding surgery alone) within the last 2 years(excluding skin cancer).
  • Chest pain.
  • Shortness of breath with minimal activity or at rest.
  • Unexplained dizziness or fainting with physical activity (exercise).
  • Chronic lung disease: Chronic Obstructive Pulmonary Disease (COPD) or asthma requiring home oxygen therapy (excluding sole use of a CPAP machine).
  • Current use of anti-diabetes medications for the treatment of diagnosed diabetes
  • Unable to communicate with research staff (including intervention staff).
  • Unable to read written English.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02000024
1109006877
No
Indiana University
Indiana University
  • Weight Watchers International
  • Indiana CTSI
  • National Diabetes Education Program
Principal Investigator: David G Marrero, Ph.D. Indiana University School of Medicine
Indiana University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP