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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000024
• Other study ID #: 1109006877
• Status: Completed
• Phase: N/A
• First received: November 26, 2013
• Last updated: April 7, 2016
• Start date: December 2011
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: March 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Obesity
• Prediabetes

Intervention

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.
• National Diabetes Education Program

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (4)

Lead Sponsor	Collaborator
Indiana University	Indiana Clinical and Translational Sciences Institute, National Diabetes Education Program, Weight Watchers International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weight		6, 12, 19 and 24 months from baseline	No
Secondary	Changes in A1c		6, 12, 19 and 24 months from baseline	No
Secondary	Changes in systolic blood pressure		6, 12, 19 and 24 months from baseline	No
Secondary	Changes in total cholesterol		6, 12, 19 and 24 months from baseline	No
Secondary	Changes in HDL-cholesterol		6, 12, 19 and 24 months from baseline	No