Table 3.
Trial Retention and Intervention Session Attendance Before and After Adding Prerequisite Orientations Sessions to Screening Protocols
| Variables | Unadjusted estimates | Estimates, regression model 2 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Beforea (no orientation sessions) | Afterb (orientation sessions) | Differencec (after-before) | Beforea (no orientation sessions) | Afterb (orientation sessions) | Differencec (after-before) | |||||
| Unadjusted estimate | Unadjusted estimate | Unadjusted estimate (95% CI) | Unadjusted estimate | Unadjusted estimate | Unadjusted estimate (95% CI) | Unadjusted difference (95% CI) | Adjusted estimate (95% CI) | Adjusted estimate (95% CI) | Adjusted difference (95% CI) | |
| Trial condition | All befored | Trial condition | All aftere | All total | All total | |||||
| Control | Intervention | Control | Intervention | |||||||
| Retention | ||||||||||
| SHINE | Active control | Mindfulness | − | Active control | Mindfulness | − | − | − | − | − |
| Sample size, n | 41 | 44 | 85 | 53 | 56 | 109 | 194 | 85 | 109 | 194 |
| % weighed at 6 months | 63.4% | 77.3% | − | 86.8% | 89.3% | − | − | − | − | − |
| % weighed at 18 months | 58.5% | 75.0% | − | 81.1% | 85.7% | − | − | − | − | − |
| % weighed, collapsed | − | − | 76.5% (67.5, 85.5) | − | − | 88.1% (82.0, 94.2) | 11.6% (0.7, 22.5) | 68.8%f (59.0, 78.6) | 86.1%g (79.6, 92.6) | 17.3%h (5.5, 29.1) |
| Get Social | Traditional | Get social | − | Traditional | Get social | − | − | − | − | − |
| Sample size, n | 36 | 39 | 75 | 71 | 71 | 142 | 217 | 75 | 142 | 217 |
| % weight obtained at 6 months | 80.6% | 82.1% | − | 94.4% | 91.6% | − | − | − | − | − |
| % weight obtained at 12 months | 77.8% | 89.7% | − | 94.4% | 95.8% | − | − | − | − | − |
| % weight obtained, collapsed | − | − | 82.7% (74.1, 91.3) | − | − | 94.0% (90.1, 97.9) | 11.3% (1.9, 20.7) | 82.7%f (74.1, 91.3) | 94.1%g (90.3, 97.9) | 11.4%h (2.0, 20.8) |
| GLOW | Usual care | Getting in balance | − | Usual care | Getting in balance | − | − | − | − | − |
| Sample size, n | 79 | 81 | 160 | 115 | 114 | 229 | 389 | 160 | 229 | 389 |
| % assessed at 32 weeks’ gestation | 94.9% | 87.7% | − | 96.5% | 93.9% | − | − | − | − | − |
| % assessed at 6 months postpartum | 96.2% | 86.4% | − | 96.5% | 94.7% | − | − | − | − | − |
| % assessed at 12 months postpartum | 97.5% | 85.2% | − | 94.8% | 94.7% | − | − | − | − | − |
| % assessed, collapsed | − | − | 94.4% (89.6, 97.4) | − | − | 97.4% (94.4, 99.0) | 3.0% (−1.0, 8.1) | 91.9%f (87.1, 95.5) | 95.6%g (92.9, 98.3) | 3.7%h (−1.3, 8.7) |
| Attendance | ||||||||||
| SHINE | Active control | Mindfulness | − | Active control | Mindfulness | − | − | − | − | − |
| Sample size, n | 41 | 44 | 85 | 53 | 56 | 109 | 194 | 85 | 109 | 194 |
| Total number of sessions | 17 | 17 | − | 17 | 17 | − | − | − | − | − |
| Mean % of sessions attended | 75.3% | 71.5% | 73.4% (68.2, 78.6) | 77.9% | 77.2% | 77.5% (73.0, 82.1) | 4.2% (−2.6, 11.0) | 73.4%i (68.3, 78.5) | 77.6%j (73.0, 82.1) | 4.2%k (−2.7, 11.0) |
| % attended 0% of sessions | 0.0% | 0.0% | 0.0% (0.0, 0.2) | 1.9% | 0.0% | 0.9% (0.0, 2.7) | 0.9% (−0.9, 2.7) | N/A | N/A | N/A |
| % attended >80% of sessions | 58.5% | 52.2% | 55.3% (44.7, 65.9) | 66.0% | 60.7% | 63.3% (54.3, 72.4) | 8.0% (−5.9, 21.9) | 55.4%f (44.8, 66.0) | 63.4%g (54.4, 72.4) | 8.0%h (−5.9, 21.9) |
| Get Social | Traditional | Get social | − | Traditional | Get social | − | − | − | − | − |
| Sample size, n | 36 | 39 | 75 | 71 | 71 | 142 | 217 | 75 | 142 | 217 |
| Total number of sessions | 22 | 22 | − | 22 | 22 | − | − | − | − | − |
| Mean % of sessions attended | 38.9% | 69.0% | 54.5% (46.0, 63.1) | 56.7% | 69.8% | 63.2% (57.9, 68.5) | 8.7% (−0.8, 18.2) | 54.2%i (46.8, 61.6) | 63.2%j (57.8, 68.6) | 9.1%k (−0.1, 18.2) |
| % attended 0% of sessions | 33.3% | 0.0% | 16.0% (7.5, 24.5) | 7.0% | 2.8% | 4.9% (1.3, 8.5) | −11.1% (−20.3, −1.9) | 14.6%f,l (7.1, 22.1) | 4.5%g,l (0.6, 8.4) | −10.1%h,l (−18.6, −1.6) |
| % attended >80% of sessions | 13.9% | 48.7% | 32.0% (21.2, 42.8) | 26.8% | 52.1% | 39.4% (31.3, 47.6) | 7.4% (−6.0, 20.9) | 29.8%f (20.1, 39.5) | 38.4%g (30.4, 46.4) | 8.6%h (−4.0, 21.2) |
| GLOW | Usual care | Getting in balance | − | Usual care | Getting in balance | − | − | − | − | − |
| Sample size, n | N/A | 81 | − | N/A | 114 | − | 81 | 114 | 195 | 195 |
| Total number of sessions | − | 13 | − | − | 13 | − | − | − | − | − |
| Mean % of sessions attended | − | 82.2% | − | − | 91.0% | − | 8.8% (−0.03, 17.6) | 82.2%i (76.0, 88.5) | 91.0%j (85.7, 96.3) | 8.8%k (0.6, 17.0) |
| % attended | − | N/A | - | - | N/A | N/A | N/A | N/A | N/A | N/A |
| 0% of sessions | ||||||||||
| % attended >80% of sessions | − | 79.0% | − | − | 88.6% | − | 9.6% (−0.9, 21.0) | 79.0%f (70.1, 87.9) | 88.6%g (82.8, 94.4) | 9.6%h (−1.0, 20.2) |
Notes: Boldface indicates statistical significance (p<0.05).
Participants enrolled before prerequisite orientations were added to trial.
Participants enrolled after prerequisite orientations were added to trial.
Difference between before and after prerequisite orientations were added to trial, collapsed across trial conditions and assessment visits.
Unadjusted estimate for all participants enrolled before prerequisite orientations were added to trial, collapsed across trial conditions and assessment visits.
Unadjusted estimate for all participants enrolled after prerequisite orientations were added to trial, collapsed across trial condition and assessment visit.
Adjusted estimated proportion for all participants enrolled before prerequisite orientations were added to trial (multiplied by 100%) from logistic regression Model 2.
Adjusted estimated proportion for all participants enrolled after prerequisite orientations were added to trial (multiplied by 100%) from logistic regression Model 2.
Difference between adjusted estimated proportions before and after prerequisite orientations were added to trial, collapsed across trial condition and assessment visit.
Adjusted estimated proportion for all participants enrolled before prerequisite orientations were added to trial, from linear regression Model 2
Adjusted estimated proportion for all participants enrolled after prerequisite orientations were added to trial, from linear regression Model 2.
Difference between adjusted estimates before and after prerequisite orientations were added to trial, collapsed across trial condition and assessment visit, from linear regression Model 2.
Analyses comparing participants who attended 0% of sessions used simple Laplace smoothing (see Methods for details).
SHINE, Supporting Health by Integrating Nutrition and Exercise; GLOW, Gestational Weight Gain and Optimal Wellness.