Clinical trial NCT02000024: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Gestational Diabetes Mellitus
Obesity
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: WW International Inc
name: Indiana Clinical and Translational Sciences Institute
name: National Diabetes Education Program
First posted: 2013-12-03
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in weight
timeFrame: 6, 12, 19 and 24 months from baseline
Secondary outcomes:
measure: Changes in A1c
timeFrame: 6, 12, 19 and 24 months from baseline
measure: Changes in systolic blood pressure
timeFrame: 6, 12, 19 and 24 months from baseline
measure: Changes in total cholesterol
timeFrame: 6, 12, 19 and 24 months from baseline
measure: Changes in HDL-cholesterol
timeFrame: 6, 12, 19 and 24 months from baseline
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: David G Marrero, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marrero DG, Palmer KN, Phillips EO, Miller-Kovach K, Foster GD, Saha CK. Comparison of Commercial and Self-Initiated Weight Loss Programs in People With Prediabetes: A Randomized Control Trial. Am J Public Health. 2016 May;106(5):949-56. doi: 10.2105/AJPH.2015.303035. Epub 2016 Feb 18.