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

Primary Purpose

Prediabetes, Gestational Diabetes Mellitus, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Watchers
National Diabetes Education Program
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Indiana University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle coaching

Lifestyle counseling

Arm Description

The existing Weight Watchers lifestyle modification program including the online support tools.

Brief advice regarding risk factors and strategies to reduce them by lifestyle modification guided by National Diabetes Education Program (NDEP) materials.

Outcomes

Primary Outcome Measures

Changes in weight

Secondary Outcome Measures

Changes in A1c
Changes in systolic blood pressure
Changes in total cholesterol
Changes in HDL-cholesterol

Full Information

First Posted
November 26, 2013
Last Updated
April 7, 2016
Sponsor
Indiana University
Collaborators
Weight Watchers International, Indiana Clinical and Translational Sciences Institute, National Diabetes Education Program
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1. Study Identification

Unique Protocol Identification Number
NCT02000024
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Weight Watchers International, Indiana Clinical and Translational Sciences Institute, National Diabetes Education Program

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes, Gestational Diabetes Mellitus, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle coaching
Arm Type
Experimental
Arm Description
The existing Weight Watchers lifestyle modification program including the online support tools.
Arm Title
Lifestyle counseling
Arm Type
Active Comparator
Arm Description
Brief advice regarding risk factors and strategies to reduce them by lifestyle modification guided by National Diabetes Education Program (NDEP) materials.
Intervention Type
Behavioral
Intervention Name(s)
Weight Watchers
Intervention 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 will highlight the recommended sessions and topics that are needed to help reduce risk.
Intervention Type
Behavioral
Intervention Name(s)
National Diabetes Education Program
Primary Outcome Measure Information:
Title
Changes in weight
Time Frame
6, 12, 19 and 24 months from baseline
Secondary Outcome Measure Information:
Title
Changes in A1c
Time Frame
6, 12, 19 and 24 months from baseline
Title
Changes in systolic blood pressure
Time Frame
6, 12, 19 and 24 months from baseline
Title
Changes in total cholesterol
Time Frame
6, 12, 19 and 24 months from baseline
Title
Changes in HDL-cholesterol
Time Frame
6, 12, 19 and 24 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Marrero, Ph.D.
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26890171
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.
Results Reference
derived

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

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