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The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. A healthy diet and stable blood glucose levels during pregnancy can prevent adverse health outcomes for the mother and the newborn child. Mobile health may be a useful supplement to prenatal care, providing women with targeted dietary information concerning GDM.
We analyzed secondary data from a two-arm, multicentered, nonblinded randomized controlled trial to determine if a smartphone app with targeted dietary information and blood glucose monitoring had an effect on the dietary behavior of women with GDM.
Women with a 2-hour oral glucose tolerance test level of ≥9 mmol/L were individually randomized to either the intervention group receiving the Pregnant+ app and usual care or the control group receiving usual care only. Eligible women were enrolled from 5 diabetes outpatient clinics in the Oslo region, Norway, between October 2015 and April 2017. The Pregnant+ app promoted 10 GDM-specific dietary recommendations. A healthy dietary score for Pregnant+ (HDS-P+) was constructed from a 41-item food frequency questionnaire and used to assess the intervention effect on the dietary behavior completed at trial entry and at around gestation week 36. Dietary changes from baseline to week 36 were examined by a paired sample two-tailed
A total of 238 women participated: 115 were allocated to the intervention group and 123 to the control group. Of the 238 women, 193 (81.1%) completed the food frequency questionnaire both at baseline and around gestational week 36. All the participants showed improvements in their HDS-P+ from baseline. However, the Pregnant+ app did not have a significant effect on their HDS-P+. The control group reported a higher weekly frequency of choosing fish meals (
Our findings do not support the supplementation of face-to-face follow-up of women with GDM with a smartphone app in the presence of high-standard usual care, as the Pregnant+ app did not have a beneficial effect on pregnant women’s diet.
ClinicalTrials.gov NCT02588729; https://clinicaltrials.gov/ct2/show/NCT02588729
Gestational diabetes mellitus (GDM) is defined as hyperglycemia detected at any time during pregnancy [
A healthy diet and stable blood glucose levels throughout pregnancy can prevent adverse health outcomes for the mother and the newborn child [
Mobile health (mHealth)—defined as medical and public health practice supported by mobile devices such as smartphones, patient monitoring devices, personal digital assistants, and other wireless devices [
We have developed the Pregnant+ app for women with GDM [
The aim of this study was to examine if the Pregnant+ app had an effect on the dietary behavior of women. No specific dietary recommendation for women with GDM existed when the study was started in 2014. Women with GDM were recommended to follow the national dietary guidelines for healthy eating [
We analyzed secondary data from a two-arm, multicentered, nonblinded RCT for women with GDM, which was conducted at 5 diabetes outpatient clinics in the Oslo region. This RCT is in accordance with the CONSORT-EHEALTH checklist (
Women with GDM were recruited from October 2015 to April 2017 by health care professionals at the diabetes outpatient clinics. At the time of recruitment, pregnant women with higher risk for GDM based on their prepregnancy weight, family history of diabetes, age, and ethnicity were sent for an OGTT [
Flow chart describing the process leading up to the final number included in the analysis of dietary behavior in the Pregnant+ study.
The participants were randomly allocated to 2 groups: intervention (access to the Pregnant+ app and usual care) and control (usual care). Randomization was performed on a 1:1 basis with allocated blocks of 4. Women who agreed to participate filled out a baseline questionnaire (Q1) on an electronic tablet (average time 30-45 minutes). After completing Q1, a computer-based program randomized and allocated the women to either the intervention or the control group. The participating women, project workers, and health care professionals at the diabetes outpatient clinics were not blinded to the allocation.
The participants in the control group received usual care for GDM according to the national guidelines [
The participants in the intervention group had access to the Pregnant+ app in addition to usual care, as described above. The women allocated to the app group could download the app from the Apple Store or Google Play at the hospital or home. The app contained 4 main icons: “Blood glucose,” “Physical activity,” “Food and beverages,” and “Diabetes information.” The 10 GDM-specific dietary recommendations that were developed for this study [
Eat healthy meals regularly.
Eat and drink little sugar.
Eat more vegetables.
Choose whole-grain products.
Limit your intake of salt.
Eat enough fish.
Choose lean dairy milk produce.
Choose healthy and less oil.
Read nutrition labels on foods before buying.
Choose water when thirsty.
The participants answered the questionnaires on an electronic tablet during their first consultation at a diabetes outpatient clinic and at their consultation around gestational week 36. The questionnaire included a 41-item food frequency questionnaire (FFQ). At baseline, they were asked to report their dietary habits prior to being diagnosed with GDM. In the second questionnaire, they were asked to report their current diet. The FFQ included the following food groups: beverages, milk and dairy products, bread and grain, fruit and vegetables, snacks, meat, and ready-to-eat meals. Answers to the questions on the frequency of intake ranged from 0 (never) to 9 (several times daily). The FFQ was based on the Fit for Delivery study and has been shown to have an adequate level of test-retest reliability [
The healthy diet score for Pregnant+ (HDS-P+) was constructed using 9 subscales, with a possible range of 0 to 90. The subscales were constructed on the basis of the dietary recommendations (second point to tenth point) provided in
Information on background characteristics was obtained from the baseline questionnaire and consisted of different socioeconomic variables: age, education, income, country of birth, marital status, economic hardship, and language. Other variables related to pregnancy and health were parity, gestational age at baseline, prior GDM, and perceived health score [
Maternal baseline characteristics were compared according to randomization status. The characteristics were presented as mean (SD) for continuous variables (independent sample two-tailed
The power calculation was for the primary outcome for the RCT [
A total of 238 women were recruited at 5 diabetes outpatient clinics in the southeast region of Norway and randomized to use the Pregnant+ app (intervention group, n=115) or no app (control group, n=123).
Background characteristics at baseline of the participants who provided dietary data at baseline (Q1) and after the intervention (Q2) in the study on the Pregnant+ app.
Background characteristics | Total, N=193 | Control group, n=98 | Intervention group, n=95 | ||
|
.11 | ||||
|
≤29 | 47 (24.4) | 22 (22) | 25 (26) |
|
|
30-37 | 110 (57.0) | 52 (53) | 58 (61) |
|
|
≥38 | 36 (18.7) | 24 (25) | 12 (13) |
|
Gestational age at baseline, mean (SD) | 27.1 (4.6) | 27.3 (4.6) | 26.9 (4.5) | .66 | |
|
.21 | ||||
|
Primiparous | 86 (44.6) | 48 (49) | 38 (40) |
|
|
Multiparous | 107 (55.4) | 50 (51) | 57 (60) |
|
|
.82 | ||||
|
No | 75(70.1) | 34 (68) | 41 (72) |
|
|
Yes | 32 (29.9) | 16 (32) | 16 (28) |
|
|
.68 | ||||
|
<24.9 | 83 (43.7) | 44 (45) | 39 (42) |
|
|
25.0-29.9 | 57 (30.0) | 26 (27) | 31 (33) |
|
|
30.0-34.9 | 31 (16.3) | 18 (19) | 13 (14) |
|
|
35.0-45.0 | 19 (10.0) | 9 (9) | 10 (11) |
|
|
.15 | ||||
|
Norway | 90 (46.6) | 52 (53) | 38 (40) |
|
|
Western Europe + United States of America | 13 (6.7) | 9 (9) | 4 (4) |
|
|
Eastern Europe | 18 (9.3) | 9 (9) | 9 (10) |
|
|
Asia | 45 (23.3) | 16 (16) | 29 (31) |
|
|
Africa | 22 (11.4) | 10 (10) | 12 (13) |
|
|
South America | 5 (2.6) | 2 (2) | 3 (3) |
|
|
.62 | ||||
|
Married/cohabiting | 179 (92.7) | 90 (92) | 89 (94) |
|
|
Single/other | 14 (7.3) | 8 (8) | 6 (6) |
|
|
.51 | ||||
|
Primary school/no education | 19 (9.8) | 12 (12) | 7 (7) |
|
|
High school | 40 (20.7) | 23 (24) | 17 (18) |
|
|
College/university<4 years | 47 (24.4) | 23 (24) | 24 (25) |
|
|
College/university≥4 years | 87 (45.1) | 40 (41) | 47 (50) |
|
|
.69 | ||||
|
No | 189 (97.9) | 96 (98) | 93 (98) |
|
|
Yes | 4 (2.1) | 2 (2) | 2 (2) |
|
|
.22 | ||||
|
Employed or self-employed | 147 (76.2) | 71 (72) | 76 (80) |
|
|
Not employed or not self-employed | 46 (23.8) | 27 (28) | 19 (20) |
|
|
.78 | ||||
|
≤59,900 USD | 57 (29.9) | 26 (27) | 31 (33) |
|
|
60,000-79,900 USD | 28 (14.2) | 14 (14) | 14 (15) |
|
|
80,000-99,900 USD | 39 (19.8) | 20 (20) | 19 (20) |
|
|
≥100,000 USD | 35 (18.8) | 20 (20) | 15 (16) |
|
|
I don’t know | 34 (17.3) | 18 (18) | 16 (17) |
|
|
.85 | ||||
|
No | 58 (30.9) | 29 (30) | 29 (32) |
|
|
Yes | 130 (69.1) | 67 (70) | 63 (69) |
|
|
.02 | ||||
|
Native Norwegian-speaking | 86 (45.1) | 52 (53) | 34 (36) |
|
|
Nonnative Norwegian-speaking | 107 (54.9) | 46 (47) | 61 (64) |
|
Perceived health score (0 |
70.8 (19.7) | 70.5 (20.5) | 71.2 (18.9) | .80 |
aGDM: gestational diabetes mellitus.
bAmong multiparous women only.
cSome values are missing.
Overall, the total HDS-P+ and most of the subscales, except the intake of healthy oils, improved from baseline to gestational week 36 (
Dietary changes from baseline to gestational week 36.a
Subscales | Baseline values, mean (SD) | Week 36 values, mean (SD) | ||
1. HDS-P+b | 40.36 (14.11) | 55.56 (13.70) | <.001 | |
2. Sugar (times/week) | 10.10 (7.88) | 1.89 (3.21) | <.001 | |
3. Vegetables (times/week) | 8.87 (3.52) | 10.35 (3.5) | <.001 | |
4. Whole grains (times/week) | 6.71 (2.96) | 8.87 (2.78) | <.001 | |
5. Salt (times/week) | 3.71 (3.10) | 2.39 (2.49) | <.001 | |
6. Fish (times/week) | 1.84 (1.17) | 2.21 (1.32) | <.001 | |
7. Low-fat milk (times/week) | 4.84 (4.08) | 4.22 (3.34) | .02 | |
8. Healthy oil (% of total dietary fat)c | 62.41 (25.32) | 65.09 (25.36) | .11 | |
9. Read nutrition labels | 5.78 (3.44) | 8.45 (2.64) | <.001 | |
10. Water (% of total fluid intake)c | 40.15 (14.67) | 51.21 (17.35) | <.001 |
aPaired sample two-tailed
bHDS-P+: healthy dietary score for Pregnant+.
cPercentage of weekly consumption.
A one-way between-group analysis of covariance was conducted to compare the effectiveness of the app on the participants’ dietary habits after being diagnosed with GDM. The women’s HDS-P+ preintervention was used as the covariate in the analysis.
Between-group differences in 10 dietary domains reported after the intervention (gestational week 36) in the Pregnant+ app.
Dietary domain | Subscale(s) | Control group, n=98, mean (SE) | Intervention group, n=95, mean (SE) | Estimated difference after interventiona, mean (SE) | 95% CI | |
Eat healthy | HDS-P+b | 56.11 (1.11) | 55.34 (1.13) | 0.77 (1.72) | –2.62, 4.16 | .65 |
Eat and drink little sugar | Sugar (times/week) | 1.97 (0.31) | 1.79 (0.32) | 0.18 (0.45) | –0.70, 1.06 | .68 |
Eat more vegetables | Vegetables (times/week) | 10.40 (0.32) | 10.30 (0.32) | 0.09 (0.45) | –0.83, 0.95 | .86 |
Choose whole grains | Whole grains (times/week) | 8.23 (0.27) | 8.01 (0.28) | 0.14 (0.40) | –0.79, 0.99 | .73 |
Limit your intake of salt | Salt (times/week) | 2.53 (0.12) | 2.25 (0.21) | 0.28 (0.31) | –0.31, 0.88 | .35 |
Eat enough fish | Fish (times/week) | 2.34 (0.09) | 2.09 (0.09) | 0.26 (0.13) | –0.01, 0.51 | .05 |
Choose lean dairy milk | Low-fat milk (times/week) | 4.40 (0.28) | 4.04 (2.85) | 0.35 (0.40) | –0.42, 1.14 | .38 |
Eat less saturated fat | Healthy oil (% of total dietary fat)c | 66.30 (2.05) | 63.80 (2.10) | 2.50 (2.50) | –3.31, 8.33 | .40 |
Read nutrition labels | Read labels | 8.76 (0.25) | 8.13 (0.25) | 0.63 (0.36) | –0.07, 1.33 | .08 |
Choose water | Water (% of total fluid intake) c | 51.93 (1.57) | 50.47 (1.59) | 1.46 (2.24) | –2.69, 5.89 | .57 |
aAnalysis of covariance adjusted for baseline HDS-P+.
bHDS-P+: healthy dietary score for Pregnant+.
cPercentage of weekly consumption.
The Pregnant+ app combined with usual care did not have any significant effect on the dietary behavior of the participants during pregnancy compared to the dietary behavior of the participants receiving usual care only. All the participants improved their diet from the time they were diagnosed with GDM to gestational week 36.
This study adds to the literature on the development and effect of pregnancy-related apps for the management of GDM and for following a healthy diet [
Compared to studies demonstrating the positive impact of apps on healthy eating and blood glucose levels [
Similar to that reported in other mHealth studies [
All the participants in this study improved their diet after being diagnosed with GDM. This is in accordance with previous research, indicating that the diagnosis of GDM motivates women to change their diets [
One of the main limitations of this study was that we did not have access to usage logs because of technical problems. To secure the participants’ privacy, we did not collect any additional data from the app. We do not know if those in the intervention group actually used the Pregnant+ app or about their frequency of usage or the pages in the app accessed by them. Our qualitative study on 17 participants from the intervention group showed that some women used the app regularly and some did not use it at all because of technical problems [
To our knowledge, this is one of the first studies to evaluate the effect of a smartphone app on the dietary behavior of women with GDM [
Screenshot of the app.
Screenshot of the dietary recommendation in the app.
CONSORT-EHEALTH Checklist (V 1.6.1).
food frequency questionnaire
gestational diabetes mellitus
healthy diet score for Pregnant+
mobile health
oral glucose tolerance test
randomized controlled trial
This study was funded by the Norwegian Research Council (identifier: 228517). We also acknowledge the participating women as well as the health care professionals and project members involved in the recruitment process.
LGH wrote the manuscript. LH and LET conducted all statistical analysis. All authors planned the study and reviewed the final manuscript.
None declared.