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

April 7, 2016 updated by: David Marrero, Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 > 180 mm Hg or diastolic >105 mm Hg.
  • 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 continuous positive airway pressure (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in weight
Time Frame: 6, 12, 19 and 24 months from baseline
6, 12, 19 and 24 months from baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in A1c
Time Frame: 6, 12, 19 and 24 months from baseline
6, 12, 19 and 24 months from baseline
Changes in systolic blood pressure
Time Frame: 6, 12, 19 and 24 months from baseline
6, 12, 19 and 24 months from baseline
Changes in total cholesterol
Time Frame: 6, 12, 19 and 24 months from baseline
6, 12, 19 and 24 months from baseline
Changes in HDL-cholesterol
Time Frame: 6, 12, 19 and 24 months from baseline
6, 12, 19 and 24 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Indiana Clinical and Translational Sciences Institute
Weight Watchers International
National Diabetes Education Program

Investigators

  • Principal Investigator: David G Marrero, Ph.D., Indiana University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

December 3, 2013

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1109006877

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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