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Study to Promote Weight Loss in Primary Care Practices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749606
First Posted: September 9, 2008
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ruth Weinstock, State University of New York - Upstate Medical University
  Purpose
The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.

Condition Intervention
Obesity Behavioral: Individual telephone intervention Behavioral: Group telephone intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program

Resource links provided by NLM:


Further study details as provided by Ruth Weinstock, State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Weight [ Time Frame: baseline, 1, 2, 3 years ]
    Weight (kg)


Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: baseline, 1, 2, 3 years ]
    Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)

  • Fasting Lipid Panel [ Time Frame: baseline, 1, 2, 3 years ]
    LDL-cholesterol (mg/dL)

  • Fasting Glucose Level [ Time Frame: baseline, 1, 2, 3 years ]
    Fasting glucose (mg/dL)

  • Health Behaviors (Diet, Physical Activity) [ Time Frame: baseline, 1, 2, 3 years ]
  • Health-related Quality of Life [ Time Frame: baseline, 1, 2, 3 years ]
  • Satisfaction Survey [ Time Frame: baseline, 1, 2, 3 years ]

Enrollment: 257
Study Start Date: June 2009
Study Completion Date: December 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individual Telephone Intervention
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
Behavioral: Individual telephone intervention
Individually administered telephone-based weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.
Active Comparator: Group Telephone Intervention
Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
Behavioral: Group telephone intervention
Group education conference calls administered weight loss intervention based on the Diabetes Prevention Program (weekly nurse calls for the first 5 weeks, then monthly, to cover the 16 topics from the Diabetes Prevention Program). In year 1 (after the first 5 weeks), the "coach" will have 3 weekly calls per month with participants. Contact will decrease to monthly in year 2. In year 3 there will be no contact arranged by study staff.

Detailed Description:
Obesity is related to the rising incidence of type 2 diabetes. Cost-effective interventions leading to sustained weight loss are needed to improve the public health and reverse the alarming rise in diabetes, its cardiovascular complications and other obesity-related illnesses. The Diabetes Prevention Program is identified as a model for a successful weight loss intervention. The proposed study is a randomized controlled trial of 2 active telephone-based interventions based on the Diabetes Prevention Model that will be delivered at primary care sites.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese
  • Metabolic syndrome
  • Read and write English
  • Planning to stay in treatment with their PCP for the next 3 years
  • On stable doses of medications for chronic diseases such as hypothyroidism for 3 years

Exclusion Criteria:

  • Unstable health
  • Diabetes mellitus
  • Severe medical comorbidities that might interfere with their ability to participate in intervention such as severe psychiatric disease or significant heart disease.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749606


Sponsors and Collaborators
State University of New York - Upstate Medical University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Ruth S. Weinstock, MD PhD State University of New York - Upstate Medical University
Principal Investigator: Paula Trief, PhD State University of New York - Upstate Medical University
  More Information

Additional Information:
Publications:
Responsible Party: Ruth Weinstock, Principal Investigator, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00749606     History of Changes
Other Study ID Numbers: R18DK078553 ( U.S. NIH Grant/Contract )
First Submitted: September 5, 2008
First Posted: September 9, 2008
Results First Submitted: June 1, 2015
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ruth Weinstock, State University of New York - Upstate Medical University:
Obesity
Metabolic syndrome
Weight loss
Diabetes prevention

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms