| Methods |
Design: 2 x 2 factorial design with two additional control groups
Purpose: examine the effect of behavioural therapy with spouse involvement on weight loss |
| Participants |
Patients: self‐referred couples with at least one obese person
Baseline comparability: yes (weight, sex, age) |
| Interventions |
Placebo: sessions with supportive group discussions about different weight loss programs
Untreated: no sessions
Experimental: sessions of behavioural therapy where the
‐person is alone and without spouse involvement by contract
‐person is alone in therapy and with spouse involvement by contract
‐couple is in therapy but without spouse involvement by contract
‐couple is in therapy and with spouse involvement by contract
(Co‐intervention: corticosteroids in 3 subjects) |
| Outcomes |
Weight loss (pounds) |
| 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 = 17 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
