Adaptation of the Diabetes Prevention Program for Primary Care

Completed · Not applicable

Conditions studied: Obesity

In brief

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 of trained lay counselors for the maintenance of weight loss. The primary endpoint of the study will be changes in weight. Secondary endpoints will include changes in body mass index (BMI), cardiovascular risk factors, health-related quality of life, and cost-effectiveness. The addition of in-person visits with the weight loss counselor is predicted to lead to greater long-term weight loss than the use of portion-controlled foods alone.

Key facts

Study ID

NCT01220089

Run by

Kaiser Permanente

People needed

106

Starts

2010-10-01

Expected to finish

2015-08-01

Last updated by the study team

2020-01-30

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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

Where it is running

• Center for Human Nutrition — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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