Clinical trial NCT00749606: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Metabolic syndrome
Weight loss
Diabetes prevention
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-09-09
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Weight
timeFrame: baseline, 1, 2, 3 years
Secondary outcomes:
measure: Blood Pressure
timeFrame: baseline, 1, 2, 3 years
measure: Fasting Lipid Panel
timeFrame: baseline, 1, 2, 3 years
measure: Fasting Glucose Level
timeFrame: baseline, 1, 2, 3 years
measure: Health Behaviors (Diet, Physical Activity)
timeFrame: baseline, 6 months, 1 and 2 years
measure: SF-12 Physical Summary Score
timeFrame: baseline, 6 months, 1 and 2 years
measure: International Physical Activity Questionnaire
timeFrame: baseline, 6 months, 1 and 2 years
Other outcomes:
Locations:
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Ruth S. Weinstock, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York - Upstate Medical University
name: Paula Trief, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.