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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prediabetes, Gestational Diabetes Mellitus, Obesity

Intervention / Treatment
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* Behavioral: Weight Watchers
* Behavioral: National Diabetes Education Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle coaching<br>The existing Weight Watchers lifestyle modification program including the online support tools. | Behavioral: Weight Watchers<br>* 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.<br>|
| Active Comparator: Lifestyle counseling<br>Brief advice regarding risk factors and strategies to reduce them by lifestyle modification guided by National Diabetes Education Program (NDEP) materials. | Behavioral: Weight Watchers<br>* 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.<br>Behavioral: National Diabetes Education Program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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