Study to Promote Weight Loss in Primary Care Practices
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ClinicalTrials.gov Identifier: NCT00749606 |
Recruitment Status
:
Completed
First Posted
: September 9, 2008
Results First Posted
: December 5, 2017
Last Update Posted
: February 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obesity | Behavioral: Individual telephone intervention Behavioral: Group telephone intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 257 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Weight Loss in Primary Care: a Translation of the Diabetes Prevention Program |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: Individual Telephone Intervention
Individually administered weight loss intervention, based on the Diabetes Prevention Program, delivered by telephone in primary care practices.
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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.
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Active Comparator: Group Telephone Intervention
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.
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- Weight [ Time Frame: baseline, 1, 2, 3 years ]Weight (kg)
- Blood Pressure [ Time Frame: baseline, 1, 2, 3 years ]Systolic blood pressure (mm Hg) / Diastolic blood pressure (mm Hg)
- Fasting Lipid Panel [ Time Frame: baseline, 1, 2, 3 years ]LDL-cholesterol (mg/dL)
- Fasting Glucose Level [ Time Frame: baseline, 1, 2, 3 years ]Fasting glucose (mg/dL)
- Health Behaviors (Diet, Physical Activity) [ Time Frame: baseline, 6 months, 1 and 2 years ]National Cancer Institute Fat screener
- SF-12 Physical Summary Score [ Time Frame: baseline, 6 months, 1 and 2 years ]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).
- International Physical Activity Questionnaire [ Time Frame: baseline, 6 months, 1 and 2 years ]Measure of physical activity is calculated as in mets/week

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749606
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 |
Additional Information:
Publications of Results:
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 ( U.S. NIH Grant/Contract ) |
First Posted: | September 9, 2008 Key Record Dates |
Results First Posted: | December 5, 2017 |
Last Update Posted: | February 12, 2018 |
Last Verified: | February 2018 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
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 |