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Study to Promote Weight Loss in Primary Care Practices
This study has been completed.
Sponsor:
State University of New York - Upstate Medical University
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
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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:
Further study details as provided by Ruth Weinstock, State University of New York - Upstate Medical University:
Primary Outcome Measures:
- Weight loss [ Time Frame: 12 months, 24 months, 36 months ]
Secondary Outcome Measures:
- Blood pressure [ Time Frame: 12 months, 24 months, 36 months ]
- Fasting lipid panel [ Time Frame: 12 months, 24 months, 36 months ]
- Fasting glucose level [ Time Frame: 12 months, 24 months, 36 months ]
- Health behaviors (diet, physical activity) [ Time Frame: 12 months, 24 months, 36 months ]
- Health-related quality of life [ Time Frame: 12 months, 24 months, 36 months ]
- Satisfaction survey [ Time Frame: 12 months, 24 months, 36 months ]
| 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.
|
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) |
| 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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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
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:
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 ( US NIH Grant/Contract Award Number ) R18DK078553-01A1 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | September 5, 2008 |
| Last Updated: | December 15, 2014 |
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 |
ClinicalTrials.gov processed this record on June 26, 2017