NCT02000024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

3.8 years

First QC Date

November 26, 2013

Last Update Submit

April 7, 2016

Conditions

PrediabetesGestational Diabetes MellitusObesity

Outcome Measures

Primary Outcomes (1)

  • Changes in weight

    6, 12, 19 and 24 months from baseline

Secondary Outcomes (4)

  • 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

Study Arms (2)

Lifestyle coaching

EXPERIMENTAL

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

Behavioral: Weight Watchers

Lifestyle counseling

ACTIVE COMPARATOR

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

Behavioral: Weight WatchersBehavioral: National Diabetes Education Program

Interventions

Weight WatchersBEHAVIORAL

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.

Lifestyle coachingLifestyle counseling
National Diabetes Education ProgramBEHAVIORAL
Lifestyle counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

    PMID: 26890171DERIVED

MeSH Terms

Conditions

Prediabetic StateDiabetes, GestationalObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David G Marrero, Ph.D.

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
J.O Ritchey Professor of Medicine. Director, Diabetes Translational Research Center

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 3, 2013

Study Start

December 1, 2011

Primary Completion

October 1, 2015

Study Completion

March 1, 2016

Last Updated

April 8, 2016

Record last verified: 2016-04

Locations

US(1)