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. 2020 May 28;8(5):e15111. doi: 10.2196/15111

Table 2.

Outcomes and bias of trials with a focus on gestational weight gain, obesity, and physical activity.

Reference Participant age (years), mean (SD) Attrition rate Main outcomes Bias tool Bias rating Bias reasoning
Soltani et al (2015) [28] 29.1 (5.4) for IGa vs 31.7 (5.8) for CGb 13% (2/16)

  • No significant difference in mean GWGc (5.6 vs 9.7 kg)

  • No significant difference in percentage of participants who exceeded the IOMd upper limit of GWG for obese women (28% vs 50%)

 NIH QATe Fair risk Small sample size
Choi et al (2016) [30] 32.9 (2.5) for IG vs 34.5 (2.5) in CG 40% to daily messages, 33% to activity diary

  • Significantly less “Lack of energy as a barrier to being active,” at week 12 in IG (P=.02)

  • No difference between groups in change in weekly mean steps (P=.23)

  • No change in numerous outcomes including CES-Df score, severity of pregnancy symptoms, self-efficacy

 Cochrane ROBTg Low risk N/Ah
Herring et al (2016) [31] 25.9 (4.9) for IG vs 25.0 (5.7) for CG Unclear

  • Significantly greater percentage of IG kept within IOM guidelines for GWG (37% vs 66%; P=.03)

  • Significant adjusted mean difference in total GWG in IG, early pregnancy to delivery (8.7 vs 12.3 kg; P=.046)

  • No significant difference in mean birth weight or babies small or large for gestational age. No difference in percentage of women with GDMi

 Cochrane ROBT Low risk N/A
Dodd (2017) [32] 30.87 (5.07) for IG vs 31.01 (6.16) for CG 38.2% (62/162)

  • No significant difference in self-reported Healthy Eating Index scores, macronutrient and food group intake, or physical activity

 Cochrane ROBT High risk High attrition, self-report, and women knew allocations
Willcox (2017) [33] 33.0 (3.4) for IG vs 32.0 (5.1) for CG 9.0% (9/100)

  • Significantly less GWG with txt4two (7.8 vs 9.7 kg; adjusted P=.04)

  • Significantly fewer txt4two women reduced their minutes of total daily physical activity over the course of the intervention (P=.001)

  • No significant difference in proportion of women exceeding IOM GWG guidelines. (47% vs 61%; adjusted P=.07)

  • No significant differences in self-reported consumption of food groups

 Cochrane ROBT High risk Women not blinded, self-reported exercise
Pollak (2014) [34] 29 (5) for IG vs 32 (2) in CG 30% (10/33)

  • No significant difference in mean weight gain, physical activity level outcomes, or nutrition score

 Cochrane ROBT High risk High proportional attrition, low sample size. Possibly randomized by study staff
Huberty (2017) [35] 31.05 (5.52) for Plus One vs 31.48 (5.44) for Plus Six vs 31.44 (4.16) for Plus Six Choice vs 30.83 (5.22) for standard 14% (13/93)

  • All 3 IGs were consolidated; when compared with controls, no difference in linear trajectories or quadratic trajectories regarding active time, light intensity time, and steps

 Cochrane ROBT Fair risk Not blinded
Redman (2017) [36] 29.0 (4.2) for remote vs 29.2 (4.8) for in person vs 29.5 (5.1) for CG Unclear

  • Significantly lower proportion of women with excess GWG in the remote group compared with usual care groups (58% vs 85%; P=.04)

  • No significant difference in GWG between the remote group and usual care (least squares mean 10.0 vs 12.8 kg; P=.07)

  • Significantly less intervention cost for remote compared with in-person group (US $97 vs US $347; P<.001)

 Cochrane ROBT High risk Randomized by unblinded intervention staff
Kennelly (2018) [37] 32.8 (4.6) for IG vs 32.1 (4.2) for CG 11.9% (67/565)

  • No significant difference in incidence of GDM (15.4% vs 14.1%; P=.71)

  • Significantly less GWG in IG (8.9 vs 10 kg; P=.02)

  • Significantly lower dietary glycemic load (P=.02) and increased exercise in IG (P=.02) after multiple correction testing

 Cochrane ROBT Fair risk Self-reported exercise and food outcomes; neither participants nor researchers blinded

aIG: intervention group.

bCG: control group.

cGWG: gestational weight gain.

dIOM: Institute of Medicine.

eNIH QAT: National Institutes of Health Quality Assessment Tool.

fCES-D: Center for Epidemiologic Studies Depression Scale.

gN/A: not applicable.

hROBT: risk of bias tool.

iGDM: gestational diabetes mellitus.