Table 4.
Study pair | Prescale RCT | Scaled-up study | Proportion of the efficacy trial effect size achieved in the scaled-up study |
---|---|---|---|
F&V intake (increases indicate improvements) | |||
AS! BC40 | RCT | Cluster RCT | |
F&V assessed using: 24-h food recall and FFQ | F&V assessed using: 24 h food recall and FFQ | ||
Change in intervention group at 3–6 mo’ follow-up: | Change in intervention group at 18-mo follow-up: | ||
Servings of fruit: +0.24, P < 0.05 | Servings of fruit: +0.2 | 83.3 | |
Servings of F&V: +0.18, P < 0.05 | Servings of F&V: +0.4 | 222.2 | |
Variety of F&V: +0.47, P < 0.05 | Variety of F&V: +0.3 | 63.8 | |
Body & Soul38 | RCT | Prospective group randomized trial | |
F&V assessed using 2-item measure (frequency and portions) of F&V | F&V assessed using 2-item measure of F&V | ||
Post-test mean differences at 6-mo follow-up, adjusted for baseline values | Post-test mean difference at 6-mo follow-up, adjusted for baseline values | ||
F&V servings/d: 2-item measure: +0.7, P < 0.05 | F&V servings/d: 2-item measure: +0.3, P = 0.16 | 42.9 | |
Fruit servings/d: 1 item: +0.4, P < 0.05 | Fruit servings/d: 1 item: +0.1, P = 0.34 | 25.0 | |
Vegetables/d: 1 item: +0.2, P < 0.05 | Vegetables servings/d: 1 item: +0.1, P = 0.11 | 50.0 | |
EuroFIT43 | RCT | RCT | |
F&V scores measured using an adapted version of the DINE | F&V scores measured using an adapted version of the DINE | ||
Adjusted b/n group differences for 12-wk and 12-mo follow-up | Adjusted between group differences for 12-wk and 12-mo follow-up | ||
F&V score: | F&V score: | ||
12 wk: 1.32 (95%CI, 1.07–1.57), P < 0.0001 | 12 wk: 1.26 (95%CI, 0.94–1.58), P < 0.001 | 95.5 | |
12 mo: 0.54 (95%CI, 0.29–0.79), P < 0.0001 | 12 mo: 0.96 (95%CI, 0.63–1.28), P < 0.001 | 177.8 | |
Tooty fruity; Munch & Move35 | RCT | Cluster RCT | |
Servings of F&V packed in lunchboxes assessed via lunchbox audits | Servings of F&V packed in lunchboxes assessed via lunchbox audits | ||
Adjusted b/n group difference at 10-mo follow-up | Adjusted b/n group difference at 6-mo follow-up | ||
F&V servings in lunchboxes: +0.61, P = 0.0013 | F&V servings in lunchboxes: −0.02 | −3.3b | |
5-a-Day37 | RCT | Cluster RCT | |
F&V intakes assessed via lunchtime observation | F&V intakes assessed via lunchtime observation | ||
Post-test b/n group differences at 12-mo follow-up. | Post-test b/n group differences at 24-mo follow-up | ||
F&V servings: +0.47, P < 0.001 | F&V servings: +0.09, P = 0.33 | 19.1 | |
Fruit servings: +0.30, P < 0.001 | Fruit servings: +0.16, P = 0.01 | 53.3 | |
F&V servings/1000 kcal: +0.83, P < 0.001 | F&V servings/1000 kcal: +0.14, P = 0.27 | 16.9 | |
Fruit servings/1000 kcal: +0.72, P < 0.001 | Fruit servings/1000 kcal: +0.22, P = 0.3 | 30.6 | |
EDNP intake (reductions indicate improvements)a | |||
EuroFIT43 | RCT | RCT | |
Diet scores measured using an adapted version of DINE. Alcohol measured using 7-d recall. | Diet scores measured using an adapted version of the DINE. Alcohol intake measured using 7-d recall. | ||
Adjusted b/n group differences for 12-wk and 12-mo follow-up | Adjusted b/n group differences for 12-wk and 12-mo follow-up | ||
Fatty food score: | Fatty food score: | ||
12 wk: −4.39 (95%CI, −5.16 to −3.61), P < 0.0001 | 12 wk: −1.65 (95%CI, −2.26 to −1.04), P < 0.001 | 37.6 | |
12 mo: −2.74(95%CI, −2.74 (−3.52 to −1.96), P < 0.0001 | 12 mo: −1.40 (95%CI, −1.97 to −0.84), P < 0.001 | 51.1 | |
Sugary food score: | Sugary food score: | ||
12 wk: −1.52 (95%CI, −1.83 to −1.21), P < 0.0001 | 12 wk: −0.94 (95%CI, −1.23 to −0.66), P < 0.001 | 61.8 | |
12 mo: −0.87 (95%CI, −1.18 to −0.56), P < 0.0001 | 12 mo: −0.67 (95%CI, −0.97 to −0.38), P < 0.001 | 77.0 | |
Tooty fruity- Munch & Move35 | RCT | Cluster-RCT | |
Servings of EDNP items packed in lunchboxes assessed via lunchbox audits. | Servings of EDNP items packed in lunchboxes assessed via lunchbox audits | ||
Adjusted b/n group difference at 10-mo follow-up | Adjusted b/n group difference at 6-mo follow-up. | ||
Children with EDNP items in lunch box, %: | Children with EDNP items in lunchbox, %: | ||
0 EDNP items: +29.1%,aP < 0.0001 | 0 EDNP items: −1%,aP = NS | −3.4a,b | |
2+ EDNP items: −24.5%, P < 0.0001 | 2+ EDNP items: +7.9%, P = NS | −32.2b | |
Other dietary outcomes | |||
Healthy Dads, Healthy Kids34 | RCT | RCT | |
Mothers of children completed the 137-item ACAES FFQ | Mothers of children completed the 120-item ACAES FFQ | ||
Post-test b/n group differences a 6-mo follow-up. | Post-test b/n group differences at 14-wk follow-up | ||
Child total energy intake (kJ/kg): mean differences between group, 87 (95%CI, 32 − 143), P = 0.01 | Child total energy intake (kJ/kg); Mean differences between groups, 35 (95%CI, −15 to 85), P = 0.17 | 40.2 |
Abbreviations: ACAES, Australian Child and Adolescent Eating Survey; EDNP, energy-dense nutrient-poor; DINE, Dietary Instrument for Nutrition Education; F&V, fruits and vegetables; FFQ, food frequency questionnaire; NS, not significant.
A greater intervention effect if percentage of children with 0 EDNP items packed in lunchboxes increased.
No proportion of the effect size was retained by scaled-up intervention (negative effect).