Methods |
Design: four group parallel trial
Purpose: examine the effect of two self‐management treatments on obese persons |
Participants |
Patients: overweight adults
Baseline comparability: NS |
Interventions |
Placebo: sessions with relaxation training
Untreated: no sessions
Experimental:
‐sessions with combined self‐management technique: based on re‐enforcement principles
‐sessions with simple self‐management technique: based on re‐enforcement principles
(Co‐intervention: information booklet on nutrition) |
Outcomes |
Weight loss (percentage of initial body weight) |
Notes |
33 out of 84 patients were college students. The standard deviation (SD) of the mean % reduction of body weight was not reported. The SD was calculated from the reported F‐test statistic. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
NS |
Allocation concealment? |
Unclear risk |
NS |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/self‐management technique) |
Blinding?
Outcome assessor |
Unclear risk |
NS |
Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
Free of selective reporting? |
Unclear risk |
No protocol available |
Free of other bias? |
Low risk |
|
No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
Trial size > 49? |
High risk |
N = 45 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |