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
  Purpose

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.


Condition Intervention
Prediabetes
Gestational Diabetes Mellitus
Obesity
Behavioral: Weight Watchers
Behavioral: National Diabetes Education Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessing the Effectiveness of a Weight Watchers-based Lifestyle Intervention for the Primary Prevention of Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Changes in weight [ Time Frame: 6, 12, 19 and 24 months from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 225
Study Start Date: December 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle coaching
The existing Weight Watchers lifestyle modification program including the online support tools.
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.
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02000024

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Weight Watchers International
Indiana CTSI
National Diabetes Education Program
Investigators
Principal Investigator: David G Marrero, Ph.D. Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT02000024     History of Changes
Other Study ID Numbers: 1109006877
Study First Received: November 26, 2013
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Diabetes, Gestational
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pregnancy Complications
Hyperglycemia

ClinicalTrials.gov processed this record on July 24, 2014