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Study to Promote Weight Loss in Primary Care Practices

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individual telephone intervention
Group telephone intervention
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Metabolic syndrome, Weight loss, Diabetes prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Individual Telephone Intervention

    Group Telephone Intervention

    Arm Description

    Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.

    Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.

    Outcomes

    Primary Outcome Measures

    Weight
    Weight (kg)

    Secondary Outcome Measures

    Blood Pressure
    Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
    Fasting Lipid Panel
    LDL-cholesterol (mg/dL)
    Fasting Glucose Level
    Fasting glucose (mg/dL)
    Health Behaviors (Diet, Physical Activity)
    National Cancer Institute Fat screener
    SF-12 Physical Summary Score
    The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health).
    International Physical Activity Questionnaire
    Measure of physical activity is calculated as in mets/week

    Full Information

    First Posted
    September 5, 2008
    Last Updated
    February 6, 2018
    Sponsor
    State University of New York - Upstate Medical University
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00749606
    Brief Title
    Study to Promote Weight Loss in Primary Care Practices
    Official Title
    Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    State University of New York - Upstate Medical University
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if primary care based, telephone-delivered weight loss interventions are effective.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity
    Keywords
    Obesity, Metabolic syndrome, Weight loss, Diabetes prevention

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Individual Telephone Intervention
    Arm Type
    Experimental
    Arm Description
    Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
    Arm Title
    Group Telephone Intervention
    Arm Type
    Active Comparator
    Arm Description
    Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Individual telephone intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group telephone intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Weight
    Description
    Weight (kg)
    Time Frame
    baseline, 1, 2, 3 years
    Secondary Outcome Measure Information:
    Title
    Blood Pressure
    Description
    Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
    Time Frame
    baseline, 1, 2, 3 years
    Title
    Fasting Lipid Panel
    Description
    LDL-cholesterol (mg/dL)
    Time Frame
    baseline, 1, 2, 3 years
    Title
    Fasting Glucose Level
    Description
    Fasting glucose (mg/dL)
    Time Frame
    baseline, 1, 2, 3 years
    Title
    Health Behaviors (Diet, Physical Activity)
    Description
    National Cancer Institute Fat screener
    Time Frame
    baseline, 6 months, 1 and 2 years
    Title
    SF-12 Physical Summary Score
    Description
    The impact of physical health on overall quality of life; higher score reflects better quality of life. Range 0-100 (0 indicates the lowest level and 100 the highest level of health).
    Time Frame
    baseline, 6 months, 1 and 2 years
    Title
    International Physical Activity Questionnaire
    Description
    Measure of physical activity is calculated as in mets/week
    Time Frame
    baseline, 6 months, 1 and 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ruth S. Weinstock, MD PhD
    Organizational Affiliation
    State University of New York - Upstate Medical University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Paula Trief, PhD
    Organizational Affiliation
    State University of New York - Upstate Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23843020
    Citation
    Weinstock RS, Trief PM, Cibula D, Morin PC, Delahanty LM. Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. J Gen Intern Med. 2013 Dec;28(12):1620-8. doi: 10.1007/s11606-013-2529-7. Epub 2013 Jul 11.
    Results Reference
    result
    PubMed Identifier
    25251749
    Citation
    Trief PM, Cibula D, Delahanty LM, Weinstock RS. Depression, stress, and weight loss in individuals with metabolic syndrome in SHINE, a DPP translation study. Obesity (Silver Spring). 2014 Dec;22(12):2532-8. doi: 10.1002/oby.20916. Epub 2014 Sep 24.
    Results Reference
    result
    PubMed Identifier
    25451907
    Citation
    Trief PM, Weinstock RS, Cibula D, Delahanty LM. Sustained weight loss one year after group telephone intervention: 3-year results from the SHINE study. Diabetes Res Clin Pract. 2014 Dec;106(3):e74-8. doi: 10.1016/j.diabres.2014.09.032. Epub 2014 Oct 5.
    Results Reference
    result
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/23843020
    Description
    Weight Loss Success in Metabolic Syndrome by Telephone Interventions: Results from the SHINE Study.

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