Kaplan 1986.

Methods	Trial design: RCT Randomisation procedure: "...were randomly assigned..." Allocation concealment: Unclear Blinding: Recipients: No Providers of Care: No Outcome Assessors: Unclear Quality Assessment Category: C (one point awarded) ‐ high risk of bias.
Participants	Country: USA Setting: Out‐patient clinic Number: 76 participants randomised to one of four groups (No indication of how many people assigned to each group was given) 70 participants were assessed at the 18 month follow‐up. Age: CG: 54.87 ± 12.32 years IG: 56.96 ± 8.95 years Sex: Overall, 42% male, 58% women. No indication of the male:female split in the individual groups. Diagnostic criteria: 1. Physicians had to complete a referral questionnaire providing confirmation of NIDDM status. Inclusion criteria: 1. Physician confirmed NIDDM. 2. Adult. Exclusion criteria: 1. Heart problems.
Interventions	Trial intervention(s): Participants assigned to this group followed the exchange diet recommended by the American Dietetic Association (around 1200 kcalories per day) and an exercise prescription based on the results of the graded exercise test. Over the ten week programme, participants received five (two hour) sessions on diet and five (two hour) sessions on exercise. Comparison intervention(s): Participants assigned to this group followed the exchange diet recommended by the American Dietetic Association (around 1200 kcalories per day). Participants attended ten (two hour) weekly sessions.
Outcomes	The mean weight loss over six months for the diet only group was 3.5kg. The mean weight loss over six months for the diet plus exercise group was 0.2kg. Although mean weight change was reported, the associated standard deviations/errors were not.) Glycated haemoglobin was measured but not reported except to say that there was "no significant difference between the groups at baseline and six month follow up". 1. HbA1c 2. Body Composition 3. Lipids were all measured at the six month follow‐up.
Notes	Source of funding of trial: Supported by grants R01 AM27901 and K04 908098 from National Institutes of Health. Financial Incentives: A deposit of $40 was requested, some of which was returned as a result of attendance.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear