Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Indianapolis, Indiana 46202


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.


Study summary:

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.


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 > 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 is Available At:


Original ID:

1109006877


NCT ID:

NCT02000024


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Indiana University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

225


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:December 2011
Completion Date:March 2016
Completion Type:Actual
Primary Completion Date:October 2015
Primary Completion Type:Actual
Verification Date:April 2016
Last Changed Date:April 7, 2016
First Received Date:November 26, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Changes in HDL-cholesterol
Time Frame:6, 12, 19 and 24 months from baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in total cholesterol
Time Frame:6, 12, 19 and 24 months from baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in systolic blood pressure
Time Frame:6, 12, 19 and 24 months from baseline
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Changes in A1c
Time Frame:6, 12, 19 and 24 months from baseline
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Changes in weight
Time Frame:6, 12, 19 and 24 months from baseline
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Weight Watchers
Description: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
Arm Name:Lifestyle coaching
Intervention Type:Behavioral
Name:National Diabetes Education Program
Arm Name:Lifestyle counseling

Study Arms

Study Arm Type:Active Comparator
Arm Name:Lifestyle counseling
Description:Brief advice regarding risk factors and strategies to reduce them by lifestyle modification guided by National Diabetes Education Program (NDEP) materials.
Study Arm Type:Experimental
Arm Name:Lifestyle coaching
Description:The existing Weight Watchers lifestyle modification program including the online support tools.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Indiana University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Weight Watchers International

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.