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



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2011
End Date:March 2016

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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.

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.

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.
We found this trial at
1
site
340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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