| Methods |
Follow‐up: 52w No. study arms: Two Setting: USA, multicenter academic centers Number: 119 Comparison: Same diet, self‐selected foods |
| Participants |
Age: 54y Sex: 58%F Duration DM: NR Treatment: No insulin BL wt, BMI: NR, 34.5 BL GHb: 8.8 |
| Interventions |
Duration: 52w Frequency: Monthly No. contacts: 12 visits Group/individual: Individual Medium: In‐person and telephone Facilitator: Nutritionist Diet: Reduced calories using pre‐prepared meals; 22% fat; calories not specified PA: None Behavioral: None |
| Outcomes |
Weight: Y BMI: >5% loss (%): Y FBS: Y GHb: Y Cholesterol: Y LDL: Y HDL: Y TG: Y SBP: Y DBP: Y |
| Notes |
Sampling method: Self (patient) selected Jadad Score: 2,2,1,A Randomization procedure: Adequate Allocation concealment: Adequate Attrition: 23% total Blinding pt: No Blinding assessor: Yes Blinding provider: No BL comparable: Yes |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
