Table 1.

Inclusion and exclusion criteria of the POUNDS LOST trial

Inclusion criteria

Men and women, age 30–70 years

Body mass index ≥25 and ≤40 kg/m2

Exclusion criteria

Unwilling to participate in the assessment visits or intervention sessions

Unwilling to modify diet according to intervention instructions

Unable to complete satisfactorily the 5-day diet record at SV2

Unlikely to adhere to the intervention based on a low score in the barriers to effective treatment or psych/eating pathology form

Vegan or other unusual diet that would be an obstacle to following any one of the diets

Intervention diets contraindicated by a medical condition

Anticipated move out of the region during the course of the study

Enrolled in another clinical trial related to weight loss or any other purpose or disease

History of stomach or gastrointestinal conditions (Inflammatory Bowel disease, Crohn’s disease, malabsorption, colostomy, bowel resection,   gastric bypass surgery, etc.)

Diabetes mellitus, treated with hypoglycemic oral medicines or insulin which cause weight gain.

Current diagnosis of psychosis or bipolar disorder, diagnosis of depression within 6 months of study start (these criteria may be waived   at site PI’s judgment)

Report of alcohol or substance abuse within 6 months or consumption of >14 alcohol drinks/week

History of treatment for eating disorder (this criterion may be waived at the site PI’s judgment)

Unstable or recent onset of cardiovascular disease within 6 months or presence of congestive heart failure

Diagnosis of cancer within 5 years, except non-melanoma skin cancer (this criterion may be waived at the site PI’s judgment)

Illness that might be associated with weight change, such as asthma (because of treatment with corticosteroids), psychosis, inflammatory bowel   disease (PI to use clinical judgment, and discuss exceptions with recruitment or steering committee)

Use of medications that might cause weight change such as systemic corticosteroids, antipsychotics, anti-depressants, anti-epileptics,   weight loss medications (including herbal preparations) (PI to use clinical judgment)

Unstable weight with loss or gain of ≥5% in the preceding 3 months

Hypothyroidism defined by elevated TSH

History of kidney failure, kidney transplant, or dialysis

Urinary microalbumin excretion, >100 mg/g creatinine, confirmed by 24-h urine

Unstable dose of medication for hyperlipidemia, hypertension, or depression/anxiety or hormone replacement therapy, unless criteria   waived by site PI

Pregnancy or nursing, or plans to become pregnant during the study

History of HIV or active Hepatitis