Study to Promote Weight Loss in Primary Care Practices

Obesity Clinical Trial

Official title:

Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749606
• Other study ID #: R18DK078553
• Secondary ID: R18DK078553
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: February 6, 2018
• Start date: June 2009
• Est. completion date: December 2014

Study information

• Verified date: February 2018
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: December 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Weight (kg)	baseline, 1, 2, 3 years
Secondary	Blood Pressure	Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)	baseline, 1, 2, 3 years
Secondary	Fasting Lipid Panel	LDL-cholesterol (mg/dL)	baseline, 1, 2, 3 years
Secondary	Fasting Glucose Level	Fasting glucose (mg/dL)	baseline, 1, 2, 3 years
Secondary	Health Behaviors (Diet, Physical Activity)	National Cancer Institute Fat screener	baseline, 6 months, 1 and 2 years
Secondary	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).	baseline, 6 months, 1 and 2 years
Secondary	International Physical Activity Questionnaire	Measure of physical activity is calculated as in mets/week	baseline, 6 months, 1 and 2 years

External Links

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