Status:
COMPLETED
Adaptation of the Diabetes Prevention Program for Primary Care
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Heart Association
Conditions:
Obesity
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The study has two primary aims. The first aim is to assess the efficacy of adding in-person visits to the use of portion-controlled foods for long-term weight loss. The second aim is to assess the use...
Detailed Description
This study will be a randomized trial of a weight control intervention, with participants recruited primarily from primary care practices at the University of Colorado. Study treatment will be deliver...
Eligibility Criteria
Inclusion
- Age 18 to 79
- Able to give informed consent
- Able to keep a food record for 7 days prior to study entry and to complete 2 screening visits and a blood draw prior to enrollment
- Willing to attend all counseling sessions, to complete study-related assessments, and to be randomized to a treatment condition after 6 months of treatment
- Has a regular primary care physician (if referred from outside the University of Colorado system)
- Body mass index (BMI) ≥ 30 kg/m2 and \< 50 kg/m2
- Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the following:
- Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including type 2 diabetes); individuals taking medications for diabetes qualify automatically
- Elevated blood pressure (≥ 130/85), including hypertension (≥ 140/90); individuals taking anti-hypertensive medication qualify automatically
- Hyperlipidemia/dyslipidemia, including any of the following: hypertriglyceridemia (TG ≥ 150); low HDL cholesterol (\< 40 for men, \< 50 for women); or taking lipid-lowering medications
- Obstructive sleep apnea -
Exclusion
- Medical conditions in which significant weight loss is normally contraindicated (e.g. pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes, Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe internal organ disease); exceptions may be made if a referring physician documents that it is safe and appropriate for the individual to lose weight
- Treated for cancer within the past 5 years, except for basal cell or squamous cell skin cancer; exceptions may be made with written permission from a physician
- Myocardial infarction or stroke within the past 6 months
- Poorly controlled hypertension (≥ 160/100); may be re-screened when controlled
- Poorly controlled diabetes (hemoglobin A1c ≥ 10.0); may be re-screened when controlled
- Weight gain or loss of ≥ 5% of weight in the past 6 months; patients who have not been weight stable may be re-screened
- Chronic use of corticosteroids or second-generation antipsychotic medications (exceptions may be made for individuals using these medications who have been weight stable for 6 months)
- Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g., poorly controlled schizophrenia, active substance abuse)
- Untreated major depression (PHQ-9 score ≥ 20)
- Pregnant or trying to become pregnant
- Social situation precluding participation in a research study (e.g., need to care for a small child or an elderly parent)
- Prior or planned bariatric surgery
- Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01220089
Start Date
October 1 2010
End Date
August 1 2015
Last Update
January 30 2020
Active Locations (1)
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1
Center for Human Nutrition
Denver, Colorado, United States, 80220