Skip to main content
. 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 2. Eligibility Criteria (Phase II).

Inclusion criteria for Phase II
 Weight loss of at least 4 kg during Phase I
 Willing not to use weight loss medications for the duration of the trial
 Willing to be randomized to maintenance phase
 Able and willing to give informed consent and participate in the interventions
Exclusion criteria for Phase II
Medical History
 Contraindication to weight loss (e.g., malignancy or other serious illness)
 Cardiovascular event since entry
 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
 Self-reported history of renal disease (other than kidney stones) since entry
 Psychiatric hospitalization since entry
 Gastric bypass surgery or fundoplication for obesity since entry, or scheduled surgery for this purpose
 Liposuction since entry, or scheduled liposuction
Medications
 Use of prescription weight loss medications
 Current use of medications for treatment of psychosis or manic-depressive illness
 Current use of medication for the treatment of diabetes
Other
 Planning to leave the area within 30 months
 Pregnant, breast feeding, or planning pregnancy prior to the end of participation
 Weight Loss Maintenance Trial staff member or household member of a Weight Loss Maintenance Trial staff person