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
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Metabolic syndrome, Weight loss, Diabetes prevention
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.
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
NCT ID
NCT00749606
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)
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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Study to Promote Weight Loss in Primary Care Practices
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