Study to Promote Weight Loss in Primary Care Practices

NCT00749606 | Completed Results DMC

• 1 other identifier: R18DK078553
• Study Type: interventional
• Target: 257
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Obesity

Keywords

Obesity; Metabolic syndrome; Weight loss; Diabetes prevention

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight (kg)

  baseline, 1, 2, 3 years

Secondary Outcomes (6)

• Blood Pressure

  baseline, 1, 2, 3 years

• Fasting Lipid Panel

  baseline, 1, 2, 3 years

• Fasting Glucose Level

  baseline, 1, 2, 3 years

• Health Behaviors (Diet, Physical Activity)

  baseline, 6 months, 1 and 2 years

• SF-12 Physical Summary Score

  baseline, 6 months, 1 and 2 years

Study Arms (2)

Individual Telephone Intervention

EXPERIMENTAL

Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.

Behavioral: Individual telephone intervention

Group Telephone Intervention

ACTIVE COMPARATOR

Group education conference calls to deliver the weight loss intervention, based upon the Diabetes Prevention Program, in primary care practices.

Behavioral: Group telephone intervention

Interventions

Individual telephone intervention BEHAVIORAL

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.

Individual Telephone Intervention

Group telephone intervention BEHAVIORAL

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.

Group Telephone Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Related Publications (3)

• 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.

  PMID: 23843020 RESULT

• 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.

  PMID: 25251749 RESULT

• 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.

  PMID: 25451907 RESULT

Related Links

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

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Results Point of Contact

• Title: Ruth S. Weinstock MD PhD
• Organization: SUNY Upstate Medical University

weinstor@upstate.edu

315-464-5740

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 9, 2008
• Study Start: June 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2014
• Last Updated: February 12, 2018
• Results First Posted: December 5, 2017

Record last verified: 2018-02