Study to Promote Weight Loss in Primary Care Practices

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: Individual telephone intervention; Behavioral: Group telephone intervention	Not Applicable

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	257 participants
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
Study Start Date :	June 2009
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	December 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Weight [ Time Frame: baseline, 1, 2, 3 years ]
   Weight (kg)

Secondary Outcome Measures :

1. Blood Pressure [ Time Frame: baseline, 1, 2, 3 years ]
   Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
2. Fasting Lipid Panel [ Time Frame: baseline, 1, 2, 3 years ]
   LDL-cholesterol (mg/dL)
3. Fasting Glucose Level [ Time Frame: baseline, 1, 2, 3 years ]
   Fasting glucose (mg/dL)
4. Health Behaviors (Diet, Physical Activity) [ Time Frame: baseline, 6 months, 1 and 2 years ]
   National Cancer Institute Fat screener
5. SF-12 Physical Summary Score [ Time Frame: baseline, 6 months, 1 and 2 years ]
   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).
6. International Physical Activity Questionnaire [ Time Frame: baseline, 6 months, 1 and 2 years ]
   Measure of physical activity is calculated as in mets/week

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Weight Loss Success in Metabolic Syndrome by Telephone Interventions: Results from the SHINE Study. 

Publications of Results:

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.

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.

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.

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 Posted:	September 9, 2008
Results First Posted:	December 5, 2017
Last Update Posted:	February 12, 2018
Last Verified:	February 2018

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