Table 2.
Population, intervention, control, outcomes, and study design (PICOS) characteristics of the included randomized controlled trials (RCTs) with available information (n=39).
| Characteristic and category | RCTs, n (%) | ||
| Study design | |||
|
|
Pilot | 13 (33) | |
|
|
Efficacy or effectiveness | 26 (67) | |
| Study arms | |||
|
|
2 | 34 (87) | |
|
|
3 | 5 (13) | |
| Sample size | |||
|
|
≤100 | 14 (36) | |
|
|
>100-1000 | 17 (44) | |
|
|
>1000 | 8 (21) | |
| Recruitment status | |||
|
|
Recruiting | 14 (36) | |
|
|
Completed | 17 (44) | |
|
|
Active, not recruiting | 2 (5) | |
|
|
Unknown | 4 (10) | |
|
|
Withdrawn or terminated | 2 (5) | |
| Recruitment timing | |||
|
|
Preconception | 3 (8) | |
|
|
First trimester | 9 (23) | |
|
|
Until or within second trimester | 22 (56) | |
|
|
Until or within third trimester | 3 (8) | |
|
|
Unknown | 2 (5) | |
| Country or continent | |||
|
|
United States | 16 (41) | |
|
|
Europe | 9 (23) | |
|
|
Asia | 7 (18) | |
|
|
Australia | 4 (10) | |
|
|
Canada | 2 (5) | |
|
|
Multiple | 1 (3) | |
| Population | |||
|
|
All BMI categories | 10 (26) | |
|
|
Normal weight + overweight + obesity | 6 (15) | |
|
|
Overweight + obesity | 16 (41) | |
|
|
Obesity | 3 (8) | |
|
|
High risk for GDMa | 4 (10) | |
| Behavior change technique or framework | |||
|
|
Any | 26 (67) | |
|
|
None | 13 (33) | |
| Implementation science framework | |||
|
|
Any | 4 (10) | |
|
|
None | 35 (90) | |
| Intervention duration | |||
|
|
Preconception (+ pregnancy) | 3 (8) | |
|
|
Pregnancy only | 23 (59) | |
|
|
Pregnancy + post partum | 10 (26) | |
|
|
Pregnancy only (intervention 1) and pregnancy + post partum (intervention 2) | 1 (3) | |
|
|
Uncertain | 2 (5) | |
| Intervention mode of delivery | |||
|
|
App only | 8 (21) | |
|
|
App + technology | 15 (39) | |
|
|
App + nontechnology | 6 (15) | |
|
|
App + technology + nontechnology | 10 (26) | |
| Lifestyle content of intervention | |||
|
|
Diet only | 5 (13) | |
|
|
PAb only | 6 (15) | |
|
|
Only well-being or sleep or both | 1 (3) | |
|
|
Diet + PA | 15 (39) | |
|
|
Diet + PA + well-being or sleep or both | 11 (28) | |
|
|
Uncertain | 1 (3) | |
| Intervention tailoringc | |||
|
|
Feedback based on tracked lifestyle data and goals | 33 (85) | |
|
|
Individual coaching sessions | 21 (54) | |
|
|
Adaptive according to risk | 9 (23) | |
| Control group | |||
|
|
Standard care | 19 (49) | |
|
|
Oral or written information | 8 (21) | |
|
|
App or website alternative | 8 (21) | |
|
|
Tracking device | 4 (10) | |
| Results on GWGd and GDM outcomes | |||
|
|
Any results reported | 18 (46) | |
|
|
No results reported | 21 (54) | |
aGDM: gestational diabetes mellitus.
bPA: physical activity.
cIndependent of the mode of delivery.
dGWG: gestational weight gain.