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. Author manuscript; available in PMC: 2010 Jan 12.
Published in final edited form as: Clin Trials. 2008;5(5):546–556. doi: 10.1177/1740774508096315

Table 1. Eligibility Criteria (Phase I).

Inclusion criteria for Phase I
 BMI of 25-45 kg/m2
 Age 25 or older
 Taking prescription medication for hypertension and/or dyslipidemia
 Personal physician permission required if diabetes present or if participant had a prior CVD event (CVD event within past 12 months is an exclusion)
 Non-positive stress test or other diagnostic test for CAD required if diabetic or if history of CVD. The stress test can be waived for participants who enter WLM currently engaging in vigorous physical activity
 Willing not to use weight loss medications for the duration of the trial
 Able and willing to give informed consent and participate in the interventions
 Access to telephone and the internet
 Demonstrated ability to access a specific web site
 Demonstrated ability to receive and respond to email
 Able to keep a complete 5-day food record during screening
Exclusion criteria for Phase I
Medical Exclusions
 Contraindication to weight loss (e.g., malignancy or other serious illness)
 Cardiovascular event within the past 12 months
 Current symptoms of angina, unless we have both physician permission and a non-positive stress test or other diagnostic test for CAD
 Evidence of active cancer diagnosis (except for non-melanoma skin cancer) or treatment in past 2 years, defined as any diagnosis or any treatment within the past 2 years
 Medication treated diabetes.
 If unmedicated diabetes, eligible if HgbA1C <8 and with both MD permission and a non-positive stress test or other diagnostic test for CAD. The stress test can be waived for participants who enter WLM currently engaging in vigorous physical activity
 Self-reported history of renal disease (other than kidney stones)
 Psychiatric hospitalization within the last 2 years
 Consumption of more than 21 alcoholic drinks per week or binge drinking
 Weight loss of > 20 lbs in the last 3 months
 Any history of gastric bypass surgery or fundoplication for obesity, or scheduled surgery for this purpose
 Liposuction in the past 12 months
Medications
 Use of prescription weight loss medications in the 3 months prior to screening.
 Current use of medications for treatment of psychosis or manic-depressive illness
Other
 Planning to leave the area within three years
 Pregnant, breast feeding, or planning pregnancy prior to the end of participation
 Current participation in another clinical trial
 Weight Loss Maintenance Trial staff member or household member of a Weight Loss Maintenance Trial staff person