What this is
- This study assesses the feasibility and acceptability of the +Stay-Active intervention for women with gestational diabetes mellitus (GDM).
- The intervention combines motivational interviewing with a smartphone application to enhance physical activity levels.
- Participants were recruited from an antenatal clinic and engaged with the intervention over a 36-week period.
Essence
- The +Stay-Active intervention was feasible and well-accepted among women with GDM, showing high engagement and retention despite lower-than-expected recruitment rates.
Key takeaways
- Recruitment was lower than anticipated, with 67 of 285 eligible women enrolling, yielding a recruitment rate of 1.5 participants per clinic.
- High engagement was observed, with 82% of participants setting goals on the Stay-Active app and 79% completing the study.
- The intervention was rated satisfactory or above by 85% of participants, indicating strong acceptability.
Caveats
- Recruitment rates were lower than expected, likely due to the COVID-19 pandemic impacting face-to-face consultations.
- The study design was non-randomized and lacked a control group, limiting the ability to draw conclusions about the intervention's effectiveness.
AI simplified
Introduction
Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance first detected during pregnancy [1]. There are serious associated complications for both mother and baby [2â4]. Glycaemic control is fundamental to GDM management [5]. Increasing blood glucose concentrations have been suggested as one of the main mechanisms for the increased risk of adverse maternal and infant outcomes [6]. Management interventions include blood glucose monitoring, lifestyle intervention and pharmacological therapy. Of those lifestyle interventions, only dietary modifications and physical activity (PA) have demonstrated possible health benefits for maternal and fetal outcomes [7].
Evidence supporting the benefits of PA amongst women with GDM is growing. Improvements in glycaemic control and reduced insulin requirements has been shown in meta-analyses of PA interventions amongst women with GDM [8, 9]. The National Institute for Health and Care Excellence (NICE), recommends women with GDM to exercise regularly, for example, walking for 30 min after a meal [10]. Women have highlighted their request for clear, simple and specific PA messages with accommodating options [11].
Behaviour Change Techniques (BCTs) are felt to be fundamental to successful PA interventions. A BCT is defined as the smallest âactive ingredientâ of an intervention. There are 93 internationally agreed and validated BCTs [12]. Techniques such as goal setting and action planning, shaping knowledge and comparison of outcomes have been effective in attenuating the observed decline of PA during pregnancy [13].
Our previous work has shown promise that motivational interviewing (using several BCTs) can help to increase PA in women with GDM [14]. Motivational interviewing was embedded into the routine clinical care for 64 women with GDM. Women were invited to a 20-min individual motivational interview focusing on increasing or maintaining PA during their pregnancy. A specific motivational interviewing framework was used. This included essential micro-skills such as individual goal setting, activity planning and specific information about the benefits and types of recommended PA. A significant increase in self-reported PA levels after two weeks was found [14]. Whilst motivational interviewing provides an initial catalyst for behaviour change, supporting these lifestyle changes remains challenging.
In the UK, many hospital trusts are using digital technologies to support remote monitoring and glycaemic control management [15]. Remote digital devices provide an enlightening prospect to support PA remotely. A smartphone application âStay-Activeâ, (referred to as the âappâ) was designed to enhance and support women following the existing motivational interviewing intervention. A systematic approach using the Behaviour Change Wheel (BCW) [16] underpinned the design of this multi-component application. Current evidence, focus groups and input from key stakeholders all informed the development process [17]. Stay-Active delivers ten BCTs through a bespoke educational resource centre, using goal setting and action planning features and tailored performance feedback with individualised messages. A distinctive feature is the cliniciansâ ability to interact with the user. Recorded PA can be reviewed by clinicians remotely and specific tailored messages can be sent to users to support their PA levels. This study aimed to determine the feasibility and acceptability of the complex intervention + Stay-Active in women with GDM. + Stay Active combines an initial motivational interview with the smartphone application âStay-Activeâ to empower and support women; utilising PA in the management of GDM. This information will determine if a randomised control trial (RCT) to evaluate this intervention is feasible.
Methods
The purpose of the study is to evaluate how women with GDM interact, engage with, and respond to a complex intervention, known as + Stay-Active. The study protocol has been previously published and contains a detailed description of the methods used, study outcomes and progression criteria [18].
Study design
A flow chart of the study design
Setting & study participants
All participants were recruited from National Health Service (NHS) maternity clinics at the Womenâs Centre, Oxford University Hospitals NHS Foundation Trust. Pregnant women at least 20 weeks gestation with a confirmed diagnosed of GDM (defined by the testing method used in this NHS hospital at the time of recruitment) were eligible to take part. During recruitment, the diagnosis of GDM was as per the NICE Diabetes in Pregnancy 2015 guideline [19]. From April 2020, the unit adopted the Royal College of Obstetricians & Gynaecologists (UK) guidance [20] during the COVID-19 pandemic. From January 2022 the unit changed to use the NICE thresholds for the 75 g OGTT diagnosis [21]. Recruitment ran from April 2021 to April 2022.
Visit 1: Recruitment and baseline assessments
| Inclusion criteria | Exclusion criteria |
|---|---|
| Women who are more than 20 completed weeks pregnant and less than 33 completed weeks pregnant with a singleton pregnancy ⢠Abnormal OGTT as defined by IADPSG, HbA1C, fasting plasma glucose or random blood glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID-19) pandemic ⢠Using GDm-Health to monitor their blood glucose ⢠Aged between 18 and 45 years ⢠Willing and able to provide informed consent for participation in the study ⢠Have and use a smartphone | ⢠Multiple pregnancy ⢠GDM not diagnosed by OGTT, HbA1C or fasting plasma glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID-19) pandemic ⢠An absolute contra-indication to physical activity as per 2019 Canadian guidelines [] e.g. preterm rupture of membranes, limited mobility, haemodynamically significant heart disease, restrictive lung disease [25] ⢠Unable to understand written or spoken English |
Intervention
Visit 2: Motivational interview & smartphone app download
At visit 2, within 7 days of enrolment, participants received the + Stay-Active intervention. This involved attending a study visit conducted online (via the secure NHS online platform âAttend Anywhereâ) or by telephone, depending on participantâs preference. During this visit, participants received a 20-min motivational interview with a trained research midwife and agreed on a set of weekly PA goals. Participants were also encouraged to download the âStay-Activeâ smartphone app and were shown the main features which include: recording their activities, reviewing their PA goals, and exploring the resource centre. Following the interview, participants completed the validated modified Oxford Maternity Diabetes Treatment Satisfaction Questionnaire (OMDTSQ) [26] (Supplement material 1) and were also asked to wear the accelerometer for a further week (total of 2 weeks) before returning it to the research team in the post.
All motivational interviews were audio recorded using a dictaphone (where participants consented to this). No patient identifiable data was recorded, the audio-file was labelled with a unique study specific number and transcriptions were de-identified. A randomly selected ten percent of motivational interview recordings were coded using the Motivational Interviewing Treatment Integrity Code (MITI 4.2.1) [27] by an experienced coder to assess the fidelity of the interview. MITI has two components: global summary scores (relational and technical dimensions) and behaviour counts. Global scores capture the coderâs overall impression of how well, or poorly, the interviewer performs in relation to the dimension being measured. Global scores are assigned to a five-point Likert scale with â1â being poor practice, â3â mixed practice, and â5â best practice. Behaviour counts are running tallies of the number of times a particular interview behaviour occurred and these are combined to give a further summary score. % Complex Reflection (%CR) is the percentage of total reflections which are judged complex (> 40% considered fair practice). A further summary of score for behaviour counts is the ratio of Reflections to Questions (R:Q): a 1:1 ratio is considered fair practice and 2:1 good practice.
Participants received a weekly telephone call from a member of the research team to review and adjust their activity goals. Participants were provided with individual motivational feedback messages from the research team at least weekly by text message via the Stay-Active app.
Follow-up assessment & completion of intervention
All participants were asked to attend a follow-up appointment at approximately 36 weeksâ gestation; during follow-up participants completed an online version of PPAQ [22], EVS [23] and OMDTSQ, and were provided with an accelerometer which they were asked to wear for 1 week before returning it to the research team by post. Participants were prompted to complete a feedback form on the intervention via the notifications on Stay-Active. The feedback form compromised of a 5- star rating system and free-text comment box to assess participants rating of goal setting, goal tracking, automated motivational messages and personalised messages about PA. A thematic analysis of the comments, and how these related back to behaviour change techniques and behaviour sources, was performed. Access to the Stay-Active app was terminated 1 week after the routine 36 weeks gestation follow-up appointment. Access was terminated as all data had been collected and support was no longer offered. The planned sample size was 60.
Study outcomes
Primary outcomes
Primary outcome criteria
| Objectives | Outcome measures | Timepoint(s) of evaluation of outcome measure |
|---|---|---|
| Primary objective | ||
| To evaluate how women with GDM interact, engage with and respond to+âand to determine whether an RCT to assess the efficacy of this intervention is feasibleStay-Active | Recruitment rates ⢠Percentage of eligible participants at the Gestational Diabetes Clinic, Women Centre, John Radcliffe Hospital ⢠Percentage of women who fulfil the eligibility criteria and accept the invitation to participate | Recruitment & at end of study period |
| Retention rate ⢠Proportion of women that completed the study | At end of the study (36 weeks) | |
| Participant engagement with the intervention ⢠Participant adherence rates to wrist worn accelerometer: ° Number of days worn over 7 days period, average daily wear, portion of wear; availability of data for PA outcome measures ⢠Attendance rate at follow-up sessions ⢠Completion rates of self-reported PA questionnaires ⢠Proportion of participants who set goals on Stay-Active ⢠Proportion of participants who recorded PA on Stay-Active | At visit 1& end of study period (36 weeksâ gestation) | |
| Acceptability: ⢠Completion of the Oxford Maternity Diabetes Treatment Satisfaction Questionnaire (OMDTSQ) by participants | Visit 2 & end of study period (36 weeks gestation) | |
| Fidelity of the intervention ⢠All Motivational Interviews will be audio recorded ⢠10% of motivational interviews will be coded using the Motivational Interviewing Treatment Integrity Code (MITI 4.2.1) to assess the fidelity of sessions | Visit 2 End of study period (36 weeks gestation) | |
| Secondary objectives | ||
| 1. Assessment of PA | Attainment of information on physical activity time, type, intensity, and frequency assessed from baseline and subsequent visits i). Device specific (accelerometer) data: (Total PA average per measured day, moderate to vigorous PA and average Acceleration) ii). PPAQ â outcome: Energy expenditure iii). EVS â Weekly minutes of Moderate to Vigorous PA | At recruitment visit 2 and visit 3 |
| 2.Usage and Participant attitudes toâ+âStay-Active | i). Stay-Active Usage: ⢠Average time spent on app per week ⢠Average time per session ⢠Frequency of app opened and duration per session ⢠Number of participant logging activity per week ii). Participants attitudes toâ+âStay-Active (5 questions rating) on the usefulness of: Motivational interviewing, goal setting, tracking your goals via the app, automated motivational messages, personalised messages and an open comments section | From visit 2 to participant completion Visit 3: 36 weeks gestation |
| 3. Assessment of blood glucose control & medication prescribed | i). Difference in glycaemic control measured as mean BG at recruitment and at 36â38Â weeks (using BG taken in the week that the accelerometer is worn), adjusted for number and timing of measurements) ii). Participantâs prescribed medication (generic name and dose) | Recruitment & Visit 3 (36Â weeksâ gestation) |
| 4. Description of maternal and Neonatal outcomes | i). Maternal outcomes (weight gain, pharmacological medication (initiation, timing and doses in relation to meals and BG readings), hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia), gestation at delivery, mode of delivery) ii). Neonatal outcomes (birth weight, neonatal hypoglycaemia, neonatal hyperbilirubinaemia, admission to SCBU forâ>â24Â h, shoulder dystocia) | Data gathered 6Â weeks post delivery |
| 5. Assessment of health costs | Number of additional visits, contacts made by research Midwife (both text message and telephone call) and time spent delivering intervention | Throughout study period |
| 6 Determine any refinements required of the intervention | Review and analysis of the primary and secondary outcome data | Following data analysis |
Secondary outcomes
Secondary outcomes include assessment of PA, usage, and participant attitudes to + Stay- Active; assessment of blood glucose measurements and control, description of maternal and neonatal outcomes, a description of additional health costs and any refinements required of the intervention (Table 2). Further details regarding the secondary outcome can be found in this studyâs protocol publication [18].
Statistics & analysis
The results consisted of descriptive statistics from assessments points. The statistics software packages Stata 14 (StataCorp, Texas, USA) and R (R Statistical Software (v4.1.2; R Core Team 2021) were used. Summary statistics were calculated for all measures. Continuous variables were reported as means, medians, standard deviations, percentiles (when appropriate), maximum and minimum values. Binary variables were reported as counts and percentages. The number of missing values were reported.
Results
Participants demographics
| Characteristic | N | mean (SD) or total (%) |
|---|---|---|
| Maternal age (years) | 67 | 33.6 (4.7) |
| Parity | ||
| 0 | 35 | 52.2% |
| 1 | 17 | 25.4% |
| 2 | 15 | 22.4% |
| Total | 67 | 100% |
| BMI at booking (kg/m)2 | 66 | 30.0 (5.4) |
| First degree relative with diabetes | ||
| No | 32 | 47.8% |
| Yes | 35 | 52.2% |
| Total | 67 | 100% |
| Previous GDM1 | ||
| No | 25 | 79.1% |
| Yes | 7 | 21.9% |
| Total | 32 | 100% |
| Previous baby weighingâ>â4.5kg1 | ||
| 0 | 25 | 78.1% |
| 1 | 6 | 18.8% |
| Unknown | 1 | 3.1% |
| Total | 32 | 100% |
| Previous Caesarean Section1 | ||
| No | 22 | 68.8% |
| Yes | 9 | 28.1% |
| Unknown | 1 | 3.1% |
| Total | 32 | 100% |
| Ethnic group | ||
| White | 46 | 68.7% |
| South Asian | 8 | 11.9% |
| African/Caribbean | 1 | 1.5% |
| East Asian | 5 | 7.5% |
| Other | 7 | 10.5% |
| Total | 67 | 100% |
| OGTT (mmol/L) | ||
| Fasting | 67 | 5.01 (1.07) |
| 2Â h | 67 | 8.21 (1.28) |
| Gestational age at recruitment (weeks) | 67 | 27.5 (2.7) |
| Weight at recruitment (kg) | 62 | 87.4 (15.7) |
| BP at recruitment (mmHg) | ||
| SBP | 67 | 110.2 (9.9) |
| DBP | 67 | 64.8 (7.3) |
| No. of patients on pharmacological treatment (metforminâÂąâinsulin) at recruitment | 1 | 1.5% |
Primary outcomes
Recruitment and retention rate
Flow chart of participants during the study
| Variable | Assessment criteria with traffic light | Study findings: | Comment: (per protocol analysis was used for traffic light coding) | |
|---|---|---|---|---|
| Recruitment rate | ||||
| Recruitment Rate (mean rate of recruitment) | Green: Average recruitment rate ofââĽâ3 participants per week Yellow: Average recruitment rateââĽâ2 butâ<â3 participants per week Red: Average recruitment rateâ<â2 participants per month | Mean recruitment rate of 1.5 participants per clinic with 2.6 women per clinic meeting inclusion criteria | Red criteria: Limited by inclusion criteria and impact of COVID pandemic on the recruitment | |
| Participant engagement with the intervention | ||||
| 60% of participants engage with the intervention | Proportion of participants assigned who wore the wrist worn accelerometer forâ>â10Â h a day forâ>â5Â days from recruitment Proportion of participants who set goals Proportion of participants who recorded PA in the app | Per protocol | Intention to treat | Green Criteria All criteria achieved |
| 78% of participants (52/67) wore the device for more than 10Â h on 5 or more days at baseline (95% CI 90, 66) 82% (55/67) of participants set goals on the Stay-Active. (95% CI 94, 70) 81% (54/67) submitted at least one PA record on the app (95% CI 93, 69 | 93% of participants (53/59) wearing the device for more than 10Â h on 5 or more days at baseline 98%(55/56) of participants set goals on the Stay-Active 98% (54/55) submitted at least one PA record on the app | |||
| Fidelity of the intervention | ||||
| 60% of the core elements of the intervention delivered as intended | Proportion of participants attended an MI meeting The audio recordings of the MI session will be coded using MITI | 83% (56/67) of participants received a motivational interview. All interviews were recorded. MITI 4.2 coding was performed for six motivational interviews chosen at random. (95% CI 95, 71) | Green Criteria All criteria achieved | |
| Retention rate | ||||
| 70% of all enrolled participants attend the 36-38Â week visit, compete a PPAQ and wear an accelerometer | Proportion of all enrolled participants | 53/67 (79%) women completed the intervention (95% CI 93, 71) | Green Criteria | |
| Assessment method: | Per Protocol | Intention to treat | ||
| Who attend the 36-38Â week follow-up visit and complete PPAQ | 39/67 (58%) completed the PPAQ (95% CI 69, 47) | 39/53 (73%) completed the PPAQ | Red Criteria | |
| Proportion of participants assigned who wore the wrist worn accelerometer forâ>â10Â h a day forâ>â5Â days at 36â38Â weeks | 61% (41/67) wore the device for more than 10Â h on 5 or more days at 36Â weeks. (95% CI 72, 50) | 85% (41/48) wearing the device for more than 10Â h on 5 or more days at 36Â weeks | Amber Criteria | |
Participant engagement with the intervention
| Exercise vital sign | ||||||||||
| mean | Median | Min | Max | SD | ||||||
| Visit 1 (baseline) (64/67 completed) | ||||||||||
| Minutes of moderate activity/ week | 126 | 90 | 5 | 560 | 98.2 | |||||
| VISIT 3 â 36Â weeks (38/67 completed) | ||||||||||
| Minutes of moderate/week | 131 | 102.5 | 20 | 420 | 86.4 | |||||
| Pregnancy physical activity questionnaire (PPAQ) | ||||||||||
| mean | min | Percentiles | Max | SD | ||||||
| 75th | 50th | 25th | ||||||||
| BASELINEâ65/67 questionnaires completed | ||||||||||
| Total MET-hr/week | 233.74 | 34.92 | 284.8 | 189.58 | 146.8 | 794 | 135.44 | |||
| Moderate activity MET-hr/week | 78.09 | 0 | 79.46 | 41.25 | 18.21 | 540 | 96.16 | |||
| Vigorous MET-hr/Week | 0.87 | 0 | 0.16 | 0 | 0 | 19.5 | 3.32 | |||
| Visit 3 â 36Â week (39/67 questionnaires completed) | ||||||||||
| Total MET-hr/week | 184.9 | 100 | 209.04 | 172.4 | 128.03 | 390 | 73.7 | |||
| Moderate activity MET-hr/week | 46.2 | 1.67 | 49.86 | 27 | 20.5 | 207 | 49.7 | |||
| Vigorous MET-hr/Week | 0.167 | 0 | 0 | 0 | 0 | 5.25 | 0.83 | |||
| Baseline (visit 1) | week 1(visit 2) | weeks 36 (visit 3) | |
|---|---|---|---|
| Number of days worn over 7Â day period for minimum 10Â h | 6.2 (1.8) | 5.8 (1.9) | 6.3 (2.3) |
| Proportion of days with 10Â h wear (%) | 88.3 (26.8) | 84.0 (27.9) | 91.0 (32. 1) |
| Number of days worn over 7Â day period for minimum 16Â h | 5.4 (2.4) | 4.8 (2.5) | 5.1 (2.6) |
| Proportion of days with 16Â h wear (%) | 77.1 (34.4) | 69.2 (3.5) | 71.6 (3.7) |
| Number of days worn over 7Â day period for minimum 24Â h | 4.1 (3.12) | 3.6 (3.1) | 3.4 (2.8) |
| Proportion of days with 24Â h wear (%) | 59.0 (44.0) | 52.0 (44.0) | 48.9 (3.9) |
| Average daily wear (hours per day) | 18.45 (7.35) | 17.59 (7.19) | 16.65 (6.5) |
| Total PA minutes* | 220.8 (80.8) | 213.7 (83.7) | 187.1 (64.2) |
| Moderate to Vigorous (MVPA) minutes* | 50.2 (23.5) | 46.2 (22.9) | 42.1 (21.6) |
| Vigorous (VPA)* | 3.3 (2.7) | 3.13 (2.7) | 2.9 (2.1) |
| Week of study | Number of registered participants | Total number of app sessions | Mean number of app sessions per participant | Mean number of sessions accessing 'record my physical activity' per participant | Mean total time (seconds) spent on app per participant | Median duration (seconds) per app session (min, max) | Median duration (seconds) per session accessing 'record my physical activity' (min, max) | Proportion of participants accessing app | Proportion of participants accessing 'record my physical activity' |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 55 | 493 | 9 | 4.2 | 341.7 | 23 (2, 487) | 18 (2, 433) | 98.2% | 94.5% |
| 2 | 55 | 312 | 5.7 | 2.7 | 139.1 | 18 (2, 276) | 13 (2, 225) | 90.9% | 70.9% |
| 3 | 55 | 347 | 6.3 | 2.3 | 154.1 | 16 (2, 398) | 11 (2, 102) | 92.7% | 76.4% |
| 4 | 55 | 281 | 5.1 | 2 | 100.9 | 15 (2, 135) | 10 (2, 60) | 83.6% | 65.5% |
| 5 | 55 | 264 | 4.8 | 2.2 | 107.3 | 15 (2, 163) | 11 (2, 91) | 80.0% | 70.9% |
| 6 | 55 | 250 | 4.5 | 2 | 103.1 | 15 (2, 260) | 11 (2, 87) | 80.0% | 61.8% |
| 7 | 54 | 244 | 4.5 | 1.4 | 87.6 | 13 (2, 181) | 10 (2, 55) | 70.4% | 53.7% |
| 8 | 50 | 190 | 3.8 | 1.5 | 73.2 | 14 (2, 172) | 12 (2, 140) | 74.0% | 54.0% |
| 9 | 49 | 152 | 3.1 | 1 | 67.6 | 15 (2, 151) | 12 (3, 46) | 61.2% | 38.8% |
| 10 | 44 | 135 | 3.1 | 1.2 | 53.6 | 13 (2, 125) | 7 (3, 63) | 56.8% | 43.2% |
| 11 | 42 | 102 | 2.4 | 0.8 | 47.7 | 12 (2, 144) | 9 (3, 107) | 52.4% | 28.6% |
| 12 | 35 | 68 | 1.9 | 0.7 | 37.8 | 13 (2, 80) | 7 (4, 68) | 45.7% | 22.9% |
| 13 | 22 | 22 | 1 | 0.2 | 17.6 | 12 (2, 89) | 6 (5, 8) | 36.4% | 13.6% |
| 14 | 17 | 18 | 1.1 | 0.2 | 12.9 | 12 (2, 33) | 8 (6, 18) | 29.4% | 11.8% |
| 15 | 8 | 7 | 0.9 | 0.4 | 12.3 | 14 (4, 26) | 8 (8, 20) | 37.5% | 12.5% |
| 16 | 2 | 3 | 1.5 | 1 | 17.5 | 13 (9, 13) | 4 (4, 8) | 50.0% | 50.0% |
| 17 | 1 | 6 | 6 | 5 | 154 | 13 (7, 73) | 8 (8, 34) | 100.0% | 100.0% |
| 18 | 1 | 2 | 2 | 2 | 36 | 17 (17, 19) | 3 (3, 10) | 100.0% | 100.0% |
| 19 | 1 | 2 | 2 | 2 | 26 | 12 (12, 14) | 6 (6, 7) | 100.0% | 100.0% |
Acceptability
The responses to the OMDTSQ indicated that women were strongly satisfied with their care throughout the study. Thirty-nine participants completed the questionnaire at visit 2 and 37 at visit 3. Supplement materialshows the satisfaction scores for each question demonstrating improvement in most domains particularly in PA specific questions at visit 3. Most participants favoured weekly feedback. 2
Fidelity of the motivational interviewing intervention
Fifty-six participants (83%) enrolled in the study received a motivational interview. All interviews were recorded. MITI 4.2 coding was performed for six motivational interviews chosen at random. Mean for relational global summary score was 3.25 (SD 0.27), technical global 3.17 (0.26), %CR 18% (14%), R:Q 0.66 (0.38). No interviews met any âgoodâ thresholds. âFairâ thresholds were met in all six interviews for technical global summary score, three interviews for relational global summary score, and one interview for %CRand R:Q.
Secondary outcomes
Physical activity assessment
Accelerometer defined PA levels across the study sample were very variable, and there was a trend for small reductions in activity between baseline and 36 weeks. On average total daily physical activity time (including light moderate and vigorous activity) reduced slightly between baseline (218.4 min per day [70.1]) and 36 weeks (195.8 min per day [64.2]). Daily moderate to vigorous activity also reduced between baseline (50.3 min per day [23.6])) and 36 weeks (43.9 min per day [22.1]) (Tables 5 & 6).
At baseline (visit 1); women reported a mean 78.09âÂąâ96.1 MET-hr/week moderate PA and vigorous PA of 0.87âÂąâ3.32 MET-hr/week (0.575âÂąâ2.49 MET-hr/week). For EVS; visit 1; the mean reported MVPA was 126 min per week (SD 98.2). At visit 3; PA levels were reduced mean 46.2âÂąâ49.7 MET-hr/week) and vigorous activity 0.1675âÂąâ0.837 MET-hr/week. However, EVS was higher than the mean reported MVPA at 131 (86.4) minutes per week.
Usage of stay-active
Fifty-five participants (82%) downloaded Stay-Active; it was used most frequently in the first six weeks of the intervention. For analysis, sessions with duration of less than two seconds were removed to reduce bias from accidental / compulsive opening of the app. In week 1; participants opened the application on average 9.0 times each, with a median duration per session of 23 (minimum 2, maximum 487) seconds. This was reduced by week 8, with 3.8 sessions per participant, and median duration of 14 (2, 172) seconds per session (Table 7). Participants logged a total of 699 physical activities (median 5 (1, 115) submissions per participant). In week 1, participants accessed the ârecord my physical activityâ section of the app on average 4.2 times each (median duration 18 (2, 433) seconds per session), this reduced to 1.5 times in week 8 (median duration 12 (2, 140) seconds). Thirty participants accessed the resource centre at least once spending an average time of 21.5 s per session.
Forty-three participants completed feedback on +Stay-Active. On a five-star rating scale (0 worst, 5 best), the percentage of participants rating the motivational interview as four or five stars was 95.3%, goal setting 97.7%, goal tracking 88.4%, automated motivational messages 76.7% and personalised messages about physical activity 93%.
| Example comment | Theme of comment / BCT | Behaviour source targeted |
|---|---|---|
| âGood to see progress in the app with regards to goals achievedââThe app is good to track what I'm doingââI would like to look back on recorded activity (what I did whenâ) | Set, monitor, and review physical activity goals Goal setting [1.1] Review behaviour goals [1.5] Self-monitoring of behaviour [2.3] Prompts and cues [7.1] | Psychological capacity Reflective motivation |
| âI have found the discussions and app both increasing my motivationââI found the app useful, easy to use and motivating.â | Increase in motivation | Reflective motivation |
| âThe messages and the notifications are a real 'keep going, you got this' messageââI find the messages and the notifications very motivating and offers support to continue goingââAs I reached 36Â weeks I found the automated messages less motivational as I was finding it more difficult to carry out physical activityââPersonally feel like the motivation isnât needed as those messages donât have any impact for meâ | Mixed views on messages and notifications Feedback on behaviour [2.2] Prompts and cues [7.1] | Psychological capacity Reflective motivation Automatic motivation |
Assessment of blood glucose control
Over the period of enrolment, mean blood glucose fell. In the first week after recruitment (at a mean gestation of 28Â weeks) the mean blood glucose was 6.3Â mmol/l which reduced to 6.1Â mmol/l for the week after the Motivational interview intervention (at a mean gestation of 29Â weeks) and reduced further to 5.8Â mmol/l at a mean gestation of 36Â weeks. This represents a change between these time points of: -0.16 (mean gestational week 28 and 29), -0.54 (mean gestational week 28 and 36) and -0.30 (mean gestational week 29 and 36). This was accounted for by a fall in both the fasting and postprandial blood glucose values (Supplement material). 3
Description of maternal and neonatal outcomes
Outcome data on 59 mother-baby pairs was available. Mean gestational age at birth was 39.2Â weeks. 14% of women had a planned caesarean section (CS), 39% of women had an unassisted vaginal birth, 32% had an emergency CS and 15% of women had an assisted vaginal birth. Thirty nine percent of women had post-partum bleeding of more than 500mls, one woman had major perineal trauma, nine women had a hypertensive disorder of pregnancy, and no women required admission to the intensive care unit. There was a mean on 0.82Â kg maternal weight gain between recruitment and last recorded weight before birth representing a mean of 0.06Â kg weight gain per week.
The mean birth weight was 3401Â g, with eight babies having a birth weight above 90th centile. 58% were female. No shoulder dystocia or neonatal hypoglycaemia requiring treatment was reported. Three babies had hyperbilirubinaemia and one had birth trauma. Four babies required admission to the neonatal intensive care for a mean duration of 1.6Â days. These adverse outcomes were assessed and found to be not related to the intervention (Supplement material). 4
Assessment of participants contacts
A total of 367 follow-up phone calls were made to participants during the study. Seventy percentage (259) were answered by participants. A total of 959 motivational SMS messages were sent from Stay-Active. An additional 75 messages were sent for the initial setup credentials and forgot password requests.
Discussion
This study is the first to explore the feasibility and acceptability of this combined intervention aimed at maintaining PA levels in women with GDM. All indicators of success were achieved within the categories for participant engagement and fidelity of the intervention, nevertheless not all were fulfilled within recruitment and retention rates. The recruitment rate was lower than expected and the mean number of participants meeting the eligibility criteria was only 2.5 participants/week; the most likely explanation is the reduction in face-to-face consultations during the COVID pandemic. An assessment of future clinical activity and the proportion of women meeting the eligibility criteria would be prudent. Once participants received the motivational interview; they appeared to remain actively engaged in the study but future considerations will be given to maximising participants attendance at this visit.
This study adds to the literature regarding the development of a complex PA intervention to aid the wider management of GDM. Management involves counselling, dietary modification, PA, glucose monitoring, and supplemental pharmacological therapies. The implementation of individual management elements vary. GDM specific smartphone apps can provide an opportunity to improve management. A systematic review of the effectiveness of mobile health applications for GDM included five RCTs and found improved trends in glycemic control, pregnancy and birth related outcomes [29]. The Apps support women with automatic transfer of blood glucose values from a glucometer to their smartphone and onwards to the supporting healthcare team, and some provided varying tailored lifestyle information on diet, PA, breastfeeding and GDM [30, 31]. Similar to + Stay-Active feedback, studies have described that these smartphone apps are appealing to women with overwhelmingly positive feedback [32]. Whilst positive results have been reported in improved compliance of blood glucose monitoring [33, 34], significantly lower blood glucose measurement and lower rate of insulin needed [34]; smartphone-based apps alone have not been clearly shown to improve pregnancy outcomes [35]. Immanuel and Simmons highlight that many studies [15, 31, 34] have been underpowered to detect improvement in pregnancy outcomes [35]. Furthermore, the specific content, measurement or analysis of any PA interventions were limited or not reported [15, 30, 31]. Our work provides a step forward in delivering, measuring, and analysing a specific PA intervention for this population.
Adherence to accelerometer measurement protocols were excellent, with moderate levels of completion rates of self-reported PA assessments and satisfaction questionnaires. This may reflect burden of the high number of questionnaires participants were expected to complete. This could be refined and re-enforces the capability to capture this data in our population.
The evidence supporting the benefits of PA among women with GDM is mounting. A further metanalysis published in 2022; concluded exercise intervention can improve the blood glucose parameters and can also reduce adverse pregnancy outcomes, such as premature birth and macrosomia [36]. This supports separate analyses that found requirements of insulin therapy, dosage and latency to administration were improved in the exercise intervention groups [8, 37]. However, most exercise interventions are supervised and well resourced; potentially being difficult to translate into the healthcare setting. Integration of health coaching and evidence based behavioural strategies (goal setting, monitor and feedback) may provide the most appropriate tools for translation of this evidence into clinical practice [38]. Multicomponent PA interventions appear to be more effective than standalone interventions [39, 40]. In our study, Women responded positively to the combination of motivational interviewing and support through Stay-Active. Re-enforcing this, is promising results from a randomised trial, that used a similar approach to + Stay-Active, found the combination of a mobile phone app and brief counselling increased objectively measured PA over 3 months in physically inactive non-pregnant women [41]. This combined approach has successfully been used to enhance the daily level of PA among older adults [42]. Within pregnant women,,motivational interviewing was found to improve adherence to healthy eating in addition to routine care in women with type 2 diabetes [43] and in a recent prospective RCT involving online health-coaching led to women increasing or at least maintaining their level of PA during the course of their pregnancy [44]. Furthermore, Smartphone apps have been found to be effective for increasing objectively measured PA in pregnant women [45].
The timing of our intervention was essential, building on a potential âteachable momentâ [46] following a diagnosis of GDM where there is opportunity for women to re-focus on PA with the health of the baby and glycaemic control being strong motivators. Potentially, optimising the effect of motivational interview.
Sustained engagement was evident with participants regularly accessing the Stay-Active app and logging activity for multiple weeks. The gradual reduction in the number of sessions and time spent on the app may represent increased familiarity of participants with the app and the effect of behaviour change, or disengagement. Evidence of sustained engagement is important, and not always evident. For example, in a large RCTs (n = 170 in each arm) to evaluate the effects of a smartphone appâbased lifestyle coaching program ((Habit-GDM) a program comprised 12 interactive lessons); only 49.4% of the intervention women accessed the educational lessons [30]. In another multicentre nested randomised trial involved 162 pregnant; whereby 77 women (77/162) in addition to lifestyle advice were provided with access to a smartphone application designed to encourage women to set dietary and PA goals and monitor their progress only 24 women (31.2%) reported using the smartphone application [47]. Motivational interviewing together with regular follow up and individualised reminder messages, helped maintain engagement over the study period. We feel there is the unique opportunity for clinicians to play a key role by interacting and supporting the service user via Stay-Active.
With the increasing number of women with GDM and greater pressures on health care providers to streamline services; digital technologies are expected to provide remote support at scale. Nevertheless, during our study support was considerable with motivational inteviews, regular telephone follow ups and over 900 text messages sent; the effectiveness on clinical outcomes will need to be balanced with intervention and implementation costs. More robust resource utilization and cost-effective analysis within GDM App studies is required [32] and needs to be consider in future work.
The study demonstrated moderate acceptability for the fidelity of motivational interviewing. with the complex reflections and ratio of reflection to questions were generally below âfairâ proficiency. This highlights motivational interviewing is a challenging skill. Multifaceted training, practice and mentoring would be required to meet the accepted proficiency thresholds in the future.
The participant characteristics were typical of this single centre and with only one participant on pharmacological medication for GDM at recruitment. Glycaemia control improved over the study period as one would expect as all women received active clinical management of their GDM. It is encouraging to see this improvement and we can conclude that the addition potential burden of this intervention did not adversely affect glycaemic control. Maternal and neonatal outcomes were also broadly as expected. Weekly weight gain was only 0.06 kg during the study period, 48% of women were on pharmacological treatment at birth which compares with historical cohorts in the same centre and suggests the intervention was not associated with a reduction in the need for pharmacological medication.
Both the PPAQ and objective accelerometer demonstrated a reduction of MVPA by visit 3; however, this is expected with activity levels typically declining during pregnancy [48]. Due to the lack of a control group, drawing conclusions regarding the impact of this intervention on the rate of decline in PA level is not possible. Additionally, there is no normative data for PPAQ within UK populations, and due to variations in methodology and study population, it is difficult to compare activity levels as measured by PPAQ between studies [49]. Within the PPAQ data set in particular, there were a small minority of outlying values with very high PA levels reported. Despite their practicality, it is an established limitation of PA self-reported data that they are subject to significant error and bias. Recalling and reporting PA is challenging, often leading to participants over or under-reporting PA. The resultant misclassification can impact the ability to detect associations or intervention-related behaviour change. With the higher levels of adherence to accelerometer measurement protocols and lower completion rates of the self-reported questionnaires; our further work would focus on using this objective measure of PA.
We believe that a larger multi-centre randomised controlled trial to investigate the effectiveness of this intervention is now warranted. Prior to this, further training is required to ensure motivation interviewing meets the accepted proficiency thresholds. Inclusion criteria should be reviewed to optimise participant recruitment and clinic activity assessed. This study demonstrated this combined behavioural change driven approach maintained high levels of engagement. There is already a commercially available CE-marked smartphone glucose management application GDm-Health [15] embedded within the clinical pathway for women with GDM at the study site, which has previously shown high levels of patient engagement, compliance and usage [26]. Given that + Stay-Active was found to be feasible and acceptable, an additional functionality to apps such as GDm-Health could be considered, improving usability and accessibility allowing users to observe the direct impact of PA of their blood glucose control.
Further work to assess whether this intervention model could be transferred to other populations of pregnant women or non-pregnant patients with comorbidities to evaulated PA and clinical outcomes, is required.
Strengths and limitations of this study
This study used several outcomes to provide evidence on the feasibility and acceptability of this complex intervention. However, the study design and size was not powered to determine intervention efficacy or clinical effectiveness. It was within a single centre, non-randomised and lacked a control group. The study partially recruited during the COVID-19 pandemic, meaning that interviews were remote and opportunities for exercise outside the home may have been limited for some women. Therefore, conclusions cannot be drawn regarding effectiveness of the intervention. Participation was not mandatory, which may have resulted in a selection bias towards those who have a tendency/preference to undertake higher levels of PA.
Conclusions
The delivery of this combined intervention designed to support PA in pregnant women was feasible and well accepted. Recruitment rate was lower than expected and affected by the COVID pandemic. Retention rates were satisfactory and there was a high level of participant compliance with PA measurements and engagement throughout the study. A future RCT to explore the efficacy of this intervention to increase PA and evaluate the effect on clinical outcomes would be feasible.
Supplementary Information
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Supplementary Material 4.