Methods |
Design: five group parallel trial
Purpose: examine the effect of self‐management behavioural therapy on weight loss |
Participants |
Patients: media‐recruited obese persons
Baseline comparability: yes (weight) |
Interventions |
Placebo: sessions of deep muscle relaxation therapy
Untreated: no sessions (waiting list)
Experimental: sessions with
‐behavioural training with standard therapist contact
‐behavioural therapy with low therapist contact
‐behavioural therapy with high therapist contact
(Co‐intervention: antihypertensive medication, fixed ordination scheme: NS) |
Outcomes |
Weight loss (percentage of initial body weight) |
Notes |
|
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/behavioural therapy) |
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 = 21 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |