A new educational film control for use in studies of active mind-body therapies: acceptability and feasibility.

OBJECTIVES: The study objectives were to ascertain whether a novel educational film class is an acceptable and feasible comparison group for a randomized controlled trial regarding the effects of an active mind-body therapy on cardiovascular disease risk in postmenopausal women. METHODS: Seventy-five (75) participants attended a baseline assessment visit and were randomly assigned to either a yoga group or an educational film (control) group. Both groups attended two 90-minute classes/week for 8 weeks, followed by a second assessment visit. Those not attending the second assessment were classified as dropouts. Over 60 films covering a range of topics relevant to the study population were evaluated; 15 were selected by consensus of at least 2 researchers and 1 layperson. Each film session followed the same format: an informal greeting period, viewing of the film, and a 15-minute postfilm discussion. To determine acceptability and feasibility of the film class, potential between-group differences in dropout and attendance were examined, and participant feedback given during class and on end-of-study questionnaires were evaluated. RESULTS: The relation between group assignment and dropout was not significant (χ(2) [1, N = 75] = 0.14, p = 0.71). One-way analysis of variance (ANOVA) indicated no significant between-group difference in number of classes attended for the yoga (X = 13.67 ± 3.10) versus film group (13.26 ± 1.97), F(1,63) = 0.39, p = 0.53). Participant feedback regarding the film program was positive. CONCLUSIONS: These findings support the feasibility and acceptability of this educational film control. Easy to standardize and tailor to a variety of populations, this film program may offer an attractive alternative to the more traditional educational control.