Study to Promote Weight Loss in Primary Care Practices

This study has been completed.

Sponsor:

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

ClinicalTrials.gov Identifier:

NCT00749606

First received: September 5, 2008

Last updated: December 15, 2014

Last verified: May 2013

History of Changes

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: Open Label Primary Purpose: Prevention
Official Title:	Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program

Resource links provided by NLM:

MedlinePlus related topics: Body Weight Weight Control

U.S. FDA Resources

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

Primary Outcome Measures:

Weight loss [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood pressure [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]
Fasting lipid panel [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]
Fasting glucose level [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]
Health behaviors (diet, physical activity) [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]
Health-related quality of life [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]
Satisfaction survey [ Time Frame: 12 months, 24 months, 36 months ] [ Designated as safety issue: No ]


Enrollment:	257
Study Start Date:	September 2008
Study Completion Date:	December 2014
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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: 2 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.

Arms

Assigned Interventions

Experimental: 1

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: 2

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Weight Loss Success in Metabolic Syndrome by Telephone Interventions: Results from the SHINE Study. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

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 R18DK078553-01A1
Study First Received:	September 5, 2008
Last Updated:	December 15, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2016

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