The MalaYsian GestatiOnal Diabetes and Prevention of DiabetES Study

Gestational Diabetes Clinical Trial

— MyGODDESS  

Official title:

A Feasibility Randomised Controlled Trial of a Mobile Phone Application for the Primary Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05204706
• Other study ID #: NMRR-21-1667-60212
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: April 2023

Study information

• Verified date: November 2022
• Source: Universiti Putra Malaysia
• Contact: BOON HOW CHEW
• Phone: 0126900652
• Email: chewboonhow[@]upm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gestational diabetes mellitus (GDM) is an increasingly common condition of pregnancy and is associated with adverse foetal, infant, and maternal outcomes. Over 50% of women with history of GDM will develop type 2 diabetes (T2D) in later life. Asian women experience disproportionate risk of both GDM and T2D compared to women from other ethnic groups. Lifestyle interventions have been proven to be effective in preventing progression to T2DM in high-risk populations. This is a two-arm, parallel feasibility RCT. Sixty Malaysian women with GDM will be randomized to receive the intervention or standard care in the antenatal period to 12 months postpartum. The intervention is a diabetes prevention intervention delivered via a smartphone application developed based on the Information-Motivation-Behavioral Skills (IMB) model of behavior change and group support utilizing motivational interviewing, which will provide women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care.

Description:

Gestational diabetes mellitus (GDM) is a global health challenge, with rates increasing around the world. The adverse short and long-term health outcomes of GDM for both mother and their offspring have been well established. In the long-terms women are up to ten times more likely to develop T2D after GDM and approximately 50% of mothers with GDM will develop diabetes within 10 years. Considerable evidence from several landmark studies has shown that healthy lifestyle interventions and behaviour change can delay or even prevent the onset of T2D in high-risk populations. Given women with prior GDM are at high risk of developing T2D earlier in their lifespan than women with normoglycemic pregnancies, intervening early with an effective diabetes prevention intervention offers a unique window of opportunity along the life-course for the prevention of T2D for the mother. Mobile health (mHealth) is a rapidly growing field of public health, defined as the use of mobile phones and other wireless technology to support the achievement of health objectives. Due to the increasing ownership rate of smartphones, significant numbers of mHealth applications 'apps' have been developed. Pregnant and postpartum women are increasingly utilising such technologies as sources of health information and services for pregnancy self-care and infant care. The overall aim of the RCT is to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention delivered via a smartphone app over 15-months in women with GDM from randomisation in the antenatal period to 12 months postpartum. Sixty participants will be recruited from three public health clinics within the southern Selangor state of Malaysia. Women will be eligible for recruitment if they meet the following criteria: i) aged above 18 years, ii) diagnosed with GDM defined using fasting blood glucose > 5.1mmol/1 or 2-hour postprandial >7.8mmol/1 which are the standard guidelines for diagnosis of GDM in Malaysia, iii) permanent resident in the state of Selangor, iv) registered in one of the study health clinics v) owning a smartphone (iOS 11 or Android 7), vi) able to speak, read, and understand English and/or Malay. Women will be excluded if they meet any of the following criteria: i) are having a twin pregnancy, ii) have type 1 or 2 diabetes, iii) have severe physical disability that would prevent any increased uptake of physical exercise, iv) have severe mental illness (psychosis, bipolar, substance dependence or active suicidal ideation), v) are currently participating in a weight loss program or diabetes prevention intervention. Women who meet study inclusion criteria and consent to study participation will be randomised to either the intervention or control arm. The intervention consists of a smartphone app for women with GDM called MyManis (the English meaning of MyManis is 'my sweet (baby)' and a virtual peer support group. The development of the app was guided by the Information-Motivation-Behavioural Skills (IMB) model of behaviour change. The MyManis app aims to provide women with information and support and motivation to act on this information to make lifestyle behaviour changes in diet and physical activity from pregnancy to post-partum. The app is available for women in both Malay and English. Women allocated to the control arm will receive standard care and no digital intervention. The overall aim of the RCT is to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention including a smartphone app and group support over 15-months in women with GDM from randomization in the antenatal period to 12 months postpartum.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged above 18 years,
• diagnosed with GDM defined using fasting blood glucose > 5.1mmol/1 or 2-hour postprandial >7.8mmol/1 which are the standard guidelines for diagnosis of GDM in Malaysia,
• permanent resident in the state of Selangor,
• registered in one of the study health clinics
• owning a smartphone (iOS 11 or Android 7) with internet connection,
• able to speak, read, and understand English and/or Malay.

Exclusion Criteria:

• are having a twin pregnancy,
• have type 1 or 2 diabetes,
• have severe physical disability that would prevent any increased uptake of physical exercise,
• have severe mental illness (psychosis, bipolar, substance dependence or active suicidal ideation),
• are currently participating in a weight loss program or diabetes prevention intervention.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• GDM
• Gestational Diabetes
• Pregnancy-Induced Diabetes

Intervention

Other:
• MyManis app
The women will receive a brochure outlining the app features and step guide on how to download the app which will be available in both Bahasa Melayu and English languages. A link to download the app via text message will also be sent to participants for convenience. Once the app has been downloaded, participants will be invited to set up an account. Once completed this will give them full access to the MyManis app. The key component of MyManis app content presented under six main tabs which are homepage, information, diet, exercise, wellbeing and GDM monitoring. The women will be invited to join group peer support through WhatsApp facilitated by a dietitian trained in motivational interviewing. The women will be notified via text message if an update of the app is required. If there's women who have not accessed the app for over a two-week period will be flagged and a notification will be sent via the app to motivate app engagement.

Locations

Country	Name	City	State
Malaysia	Klinik Kesihatan Puchong Batu 14	Petaling Jaya	Selangor
Malaysia	Klinik Kesihatan Putrajaya Presint 9	Putrajaya	Wilayah Persekutuan
Malaysia	Klinik Kesihatan Seri Kembangan	Seri Kembangan	Selangor

Sponsors (4)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	King's College London, Ministry of Education, Malaysia, Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (3)

Benton M, Iman I, Goldsmith K, Forbes A, Ching SM, Papachristou Nadal I, Guess N, Murphy HR, Mohd Yusof BN, Baharom A, Mahamad Sobri NH, Basri NI, Salim MS, Ismail IZ, Hassan F, Ismail K, Chew BH. A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2022 Sep 8;11(9):e37288. doi: 10.2196/37288. — View Citation

Mohd Sa'id, I. I., Papachristou Nadal, I., Forbes, A., Goldsmith, K., Ismail, I. Z., Hassan, F., Ching, S. M., Guess, N., Murphy, H., Prina, M., Mohd Yusoff, B. N., Basri, N. I., Binti Salim, M. S., Mahamad Sobri, N. H., Har Yap, P. P., Ismail, K., & Chew, B. H. (2021). A Protocol of Process Evaluations of Interventions for the Prevention of Type 2 Diabetes in Women With Gestational Diabetes Mellitus: A Systematic Review. International Journal of Qualitative Methods, 20. https://doi.org/10.1177/16094069211034010

Sobri NHM, Ismail IZ, Hassan F, Papachristou Nadal I, Forbes A, Ching SM, Ali H, Goldsmith K, Murphy H, Guess N, Mohd Yusof BN, Basri NI, Salim MS, Azmiyaty C, Mohd Sa'id II, Chew BH, Ismail K; MYGODDESS Project Team. Protocol for a qualitative study exploring the perception of need, importance and acceptability of a digital diabetes prevention intervention for women with gestational diabetes mellitus during and after pregnancy in Malaysia (Explore-MYGODDESS). BMJ Open. 2021 Aug 26;11(8):e044878. doi: 10.1136/bmjopen-2020-044878. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body weight at T0	Weight (kg)	Collected antenatally at T0: 30 weeks pregnancy
Other	Body weight at T1	Weight (kg)	Collected antenatally at T1: 36 weeks pregnancy
Other	Body weight at T2	Weight (kg)	Collected antenatally at T2: 3 months after delivery
Other	Body weight at T3	Weight (kg)	Collected antenatally at T3: 6 months after delivery
Other	Body weight at T4	Weight (kg)	Collected antenatally at T4: 9 months after delivery
Other	Body weight at T5	Weight (kg)	Collected antenatally at T5: 12 months after delivery
Other	Height at T0	measured for 1 time only (in centimetres, cm)	Collected antenatally at T0: 30 weeks pregnancy
Other	Body mass index at T0	calculated as body weight divided by (heightxheight) (kg/m^2)	Collected antenatally at T0: 30 weeks pregnancy
Other	Body mass index at T1	calculated as body weight divided by (heightxheight) (kg/m^2)	Collected antenatally at T1: 36 weeks pregnancy
Other	Body mass index at T2	calculated as body weight divided by (heightxheight) (kg/m^2)	Collected antenatally at T2: 3 months after delivery
Other	Body mass index at T3	calculated as body weight divided by (heightxheight) (kg/m^2)	Collected antenatally at T3: 6 months after delivery
Other	Body mass index at T4	calculated as body weight divided by (heightxheight) (kg/m^2)	Collected antenatally at T4: 9 months after delivery
Other	Body mass index at T5	calculated as body weight divided by (heightxheight) (kg/m^2)	Collected antenatally at T5: 12 months after delivery
Other	Body fat percentage at T0	Body fat percentage reported in % (to 1 decimal point)	Collected antenatally at T0: 30 weeks pregnancy
Other	Body fat percentage at T1	Body fat percentage reported in % (to 1 decimal point)	Collected antenatally at T1: 36 weeks pregnancy
Other	Body fat percentage at T2	Body fat percentage reported in % (to 1 decimal point)	Collected antenatally at T2: 3 months after delivery
Other	Body fat percentage at T3	Body fat percentage reported in % (to 1 decimal point)	Collected antenatally at T3: 6 months after delivery
Other	Body fat percentage at T4	Body fat percentage reported in % (to 1 decimal point)	Collected antenatally at T4: 9 months after delivery
Other	Body fat percentage at T5	Body fat percentage reported in % (to 1 decimal point)	Collected antenatally at T5: 12 months after delivery
Other	Blood pressure reading at T0	measure systolic and diastolic blood pressure (mmHg)	Collected antenatally at T0: 30 weeks pregnancy
Other	Blood pressure reading at T1	measure systolic and diastolic blood pressure (mmHg)	Collected antenatally at T1: 36 weeks pregnancy
Other	Blood pressure reading at T3	measure systolic and diastolic blood pressure (mmHg)	Collected antenatally at T3: 6 months after delivery
Other	Blood pressure reading at T5	measure systolic and diastolic blood pressure (mmHg)	Collected antenatally at T5: 12 months after delivery
Other	Total Cholestrol at T0	Total Cholestrol (mmol/L)	Collected antenatally at T0: 30 weeks pregnancy
Other	Total Cholestrol at T1	Total Cholestrol (mmol/L)	Collected antenatally at T1: 36 weeks pregnancy
Other	Total Cholestrol at T3	Total Cholestrol (mmol/L)	Collected antenatally at T3: 6 months after delivery
Other	Total Cholestrol at T5	Total Cholestrol (mmol/L)	Collected antenatally at T5: 12 months after delivery
Other	Low Density Lipoprotein Cholestrol at T0	Low Density Lipoprotein Cholestrol, LDL (mmol/L)	Collected antenatally at T0: 30 weeks pregnancy
Other	Low Density Lipoprotein Cholestrol at T1	Low Density Lipoprotein Cholestrol, LDL (mmol/L)	Collected antenatally at T1: 36 weeks pregnancy
Other	Low Density Lipoprotein Cholestrol at T3	Low Density Lipoprotein Cholestrol, LDL (mmol/L)	Collected antenatally at T3: 6 months after delivery
Other	Low Density Lipoprotein Cholestrol at T5	Low Density Lipoprotein Cholestrol, LDL (mmol/L)	Collected antenatally at T5: 12 months after delivery
Other	High Density Lipoprotein cholesterol at T0	High Density Lipoprotein cholesterol, HDL (mmol/L)	Collected antenatally at T0: 30 weeks pregnancy
Other	High Density Lipoprotein cholesterol at T1	High Density Lipoprotein cholesterol, HDL (mmol/L)	Collected antenatally at T1: 36 weeks pregnancy
Other	High Density Lipoprotein cholesterol at T3	High Density Lipoprotein cholesterol, HDL (mmol/L)	Collected antenatally at T3: 6 months after delivery
Other	High Density Lipoprotein cholesterol at T5	High Density Lipoprotein cholesterol, HDL (mmol/L)	Collected antenatally at T5: 12 months after delivery
Other	HbA1c at T0	HbA1c (%)	Collected antenatally at T0: 30 weeks pregnancy
Other	HbA1c at T1	HbA1c (%)	Collected antenatally at T1: 36 weeks pregnancy
Other	HbA1c at T3	HbA1c (%)	Collected antenatally at T3: 6 months after delivery
Other	HbA1c at T5	HbA1c (%)	Collected antenatally at T5: 12 months after delivery
Other	Fasting blood glucose at T0	Fasting blood glucose (mmol/l)	Collected antenatally at T0: 30 weeks pregnancy
Other	Fasting blood glucose at T1	Fasting blood glucose (mmol/l)	Collected antenatally at T1: 36 weeks pregnancy
Other	Oral glucose tolerance test (OGTT) Fasting at T3	Oral glucose tolerance test (OGTT) Fasting (mmol/l)	Collected antenatally at T3: 6 months after delivery
Other	Oral glucose tolerance test (OGTT) Fasting at T5	Oral glucose tolerance test (OGTT) Fasting (mmol/l)	Collected antenatally at T5: 12 months after delivery
Other	Oral glucose tolerance test (OGTT) 2-hour Postprandial at T3	Oral glucose tolerance test (OGTT) 2-hour Postprandial (mmol/l)	Collected antenatally at T3: 6 months after delivery
Other	Oral glucose tolerance test (OGTT) 2-hour Postprandial at T5	Oral glucose tolerance test (OGTT) 2-hour Postprandial (mmol/l)	Collected antenatally at T5: 12 months after delivery
Other	Fasting Serum Insulin at T0	Fasting Serum Insulin (U/mL)	Collected antenatally at T0: 30 weeks pregnancy
Other	Fasting Serum Insulin at T1	Fasting Serum Insulin (U/mL)	Collected antenatally at T1: 36 weeks pregnancy
Other	Fasting Serum Insulin at T3	Fasting Serum Insulin (U/mL)	Collected antenatally at T3: 6 months after delivery
Other	Fasting Serum Insulin at T5	Fasting Serum Insulin (U/mL)	Collected antenatally at T5: 12 months after delivery
Other	Insulin resistance at T0	Insulin resistance (HOMA-IR)	Collected antenatally at T0: 30 weeks pregnancy
Other	Insulin resistance at T1	Insulin resistance (HOMA-IR)	Collected antenatally at T1: 36 weeks pregnancy
Other	Insulin resistance at T3	Insulin resistance (HOMA-IR)	Collected antenatally at T3: 6 months after delivery
Other	Insulin resistance at T5	Insulin resistance (HOMA-IR)	Collected antenatally at T5: 12 months after delivery
Other	Total score for Self-efficacy for exercise at T0	This scale consist of 18 items whereby the response options are ranging from 0-100, ranging in 10-unit intervals from 0 (cannot do); through intermediate degrees of assurance, 50 (moderately certain can do); to complete assurance, 100 (highly certain can do). The scale is scored by summing the numerical ratings for each response and dividing by the number of responses. Higher scores indicates higher self-efficacy for exercise.	Collected at T0: 30 weeks pregnancy
Other	Total score for Self-efficacy for exercise at T3	This scale consist of 18 items whereby the response options are ranging from 0-100, ranging in 10-unit intervals from 0 (cannot do); through intermediate degrees of assurance, 50 (moderately certain can do); to complete assurance, 100 (highly certain can do). The scale is scored by summing the numerical ratings for each response and dividing by the number of responses. Higher scores indicates higher self-efficacy for exercise.	Collected at T3: 6 months after delivery
Other	Total score for Self-efficacy for exercise at T5	This scale consist of 18 items whereby the response options are ranging from 0-100, ranging in 10-unit intervals from 0 (cannot do); through intermediate degrees of assurance, 50 (moderately certain can do); to complete assurance, 100 (highly certain can do). The scale is scored by summing the numerical ratings for each response and dividing by the number of responses. Higher scores indicates higher self-efficacy for exercise.	Collected at T5: 12 months after delivery
Other	Mother-infant relationship at T0	The mother-infant relationship will be assessed using the Maternal Antenatal Attachment Scale which comprises 19 items with response options presented on a 5-point Likert scale. A total score is obtained by summing the responses to the 19 items, resulting in a possible scoring range of 19 to 95. Higher scores are indicative of stronger attachment.	Collected at 30 weeks pregnancy
Other	Mother-infant relationship at T3	The mother-infant relationship will be assessed using the Maternal Antenatal Attachment Scale which comprises 19 items with response options presented on a 5-point Likert scale. A total score is obtained by summing the responses to the 19 items, resulting in a possible scoring range of 19 to 95. Higher scores are indicative of stronger attachment.	Collected at 6 months after delivery
Other	Mother-infant relationship at T5	The mother-infant relationship will be assessed using the Maternal Antenatal Attachment Scale which comprises 19 items with response options presented on a 5-point Likert scale. A total score is obtained by summing the responses to the 19 items, resulting in a possible scoring range of 19 to 95. Higher scores are indicative of stronger attachment.	Collected at 12 months after delivery
Other	Depressive symptoms at T0	The questionnaire consist of 10 items. Add up all checked (Tick) boxes on PHQ-9. For every tick boxes: the score indicated is as below: 0= Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day. Then add the subtotal to produce a total score. The possible range score is 0-27.	Collected at T0: 30 weeks pregnancy
Other	Depressive symptoms at T3	The questionnaire consist of 10 items. Add up all checked (Tick) boxes on PHQ-9. For every tick boxes: the score indicated is as below: 0= Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day. Then add the subtotal to produce a total score. The possible range score is 0-27.	Collected at T3: 6 months after delivery
Other	Depressive symptoms at T5	The questionnaire consist of 10 items. Add up all checked (Tick) boxes on PHQ-9. For every tick boxes: the score indicated is as below: 0= Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day. Then add the subtotal to produce a total score. The possible range score is 0-27.	Collected at T5: 12 months after delivery
Other	Dietary intake at T0	Total macronutrient intake from standardised multiple-pass 24-hour dietary recall)	Collected at T0: 30 weeks pregnancy
Other	Dietary intake at T3	Total macronutrient intake from standardised multiple-pass 24-hour dietary recall)	Collected at T3: 6 months after delivery
Other	Dietary intake at T5	Total macronutrient intake from standardised multiple-pass 24-hour dietary recall)	Collected at T5: 12 months after delivery
Other	Physical activity at T0	The questionnaire consist of 7 items. The total score will be reported as a continuous measure and reported as median METminutes. Median values can be computed for walking (W), moderate-intensity activities (M), and vigorous-intensity activities (V) using the following formulas: MET values and Formula for computation of Met-minutes Walking MET-minutes/week = 3.3 * walking minutes * walking days Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days A combined total physical activity MET-min/week can be computed as the sum of Walking + Moderate + Vigorous MET-min/week scores.	Collected at T0: 30 weeks pregnancy
Other	Physical activity at T3	The questionnaire consist of 7 items. The total score will be reported as a continuous measure and reported as median METminutes. Median values can be computed for walking (W), moderate-intensity activities (M), and vigorous-intensity activities (V) using the following formulas: MET values and Formula for computation of Met-minutes Walking MET-minutes/week = 3.3 * walking minutes * walking days Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days A combined total physical activity MET-min/week can be computed as the sum of Walking + Moderate + Vigorous MET-min/week scores.	Collected at T3: 6 months after delivery
Other	Physical activity at T5	The questionnaire consist of 7 items. The total score will be reported as a continuous measure and reported as median METminutes. Median values can be computed for walking (W), moderate-intensity activities (M), and vigorous-intensity activities (V) using the following formulas: MET values and Formula for computation of Met-minutes Walking MET-minutes/week = 3.3 * walking minutes * walking days Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days A combined total physical activity MET-min/week can be computed as the sum of Walking + Moderate + Vigorous MET-min/week scores.	Collected at T5: 12 months after delivery
Other	mean step count at T0	Number of steps in inbuild smartphone app	Collected at T0: 30 weeks pregnancy
Other	mean step count at T3	Number of steps in inbuild smartphone app	Collected at T3: 6 months after delivery
Other	mean step count at T5	Number of steps in inbuild smartphone app	Collected at T5: 12 months after delivery
Other	Infant feeding T3	Type of feeding status	Collected at T3: 6 months after delivery
Other	Infant feeding at T5	Type of feeding status	Collected at T5: 12 months after delivery
Other	Alcohol intake at T0	Frequency of intake	Collected at T0: 30 weeks pregnancy
Other	Alcohol intake at T3	Frequency of intake	Collected at T3: 6 months after delivery
Other	Alcohol intake at T5	Frequency of intake	Collected at T5: 12 months after delivery
Other	Smoking status at T0	type of smoker	Collected at T0: 30 weeks pregnancy
Other	Smoking status at T3	type of smoker	Collected at T3: 6 months after delivery
Other	Smoking status at T5	type of smoker	Collected at T5: 12 months after delivery
Other	Recruitment rate	number of eligible, consented, screened, enrolled, and randomised	Collected at 30 weeks pregnancy
Other	T1 Dosage delivered - app download	The number of MyManis app delivered by the researcher and the number of app downloads (n) by the participant.	Collected at T1: 36 weeks pregnancy
Other	T3 Dosage delivered - app download	The number of MyManis app delivered by the researcher and the number of app downloads (n) by the participant.	Collected at T3: 6 months after delivery
Other	T5 Dosage delivered - app download	The number of MyManis app delivered by the researcher and the number of app downloads (n) by the participant.	Collected at T5: 12 months after delivery
Other	T1 Dosage delivered - Support group	Total number of group support sessions (n) planned to deliver by the dietitian train in motivational interviewing.	Collected at T1: 36 weeks pregnancy
Other	T3 Dosage delivered - Support group	Total number of group support sessions (n) planned to deliver by the dietitian train in motivational interviewing.	Collected at T3: 6 months after delivery
Other	T5 Dosage delivered - Support group	Total number of group support sessions (n) planned to deliver by the dietitian train in motivational interviewing.	Collected at T5: 12 months after delivery
Other	T1 Dosage received - Participant's engagement	The number of participant log into MyManis app per month (n)	Collected at T1: 36 weeks pregnancy
Other	T3 Dosage received - Participant's engagement	The number of participant log into MyManis app per month (n)	Collected at T3: 6 months after delivery
Other	T5 Dosage received - Participant's engagement	The number of participant log into MyManis app per month (n)	Collected at T5: 12 months after delivery
Other	T1 Dosage received - length of log in	This is an extent to which participant's engagement through length of participant log into MyManis app (hours and minutes)	Collected at T1: 36 weeks pregnancy
Other	T3 Dosage received - length of log in	This is an extent to which participant's engagement through length of participant log into MyManis app (hours and minutes)	Collected at T3: 6 months after delivery
Other	T5 Dosage received - length of log in	This is an extent to which participant's engagement through length of participant log into MyManis app (hours and minutes)	Collected at T5: 12 months after delivery
Other	T1 Dosage received - time spent on DIET component	Participant time spent on DIET component (hours and minutes)	Collected at T1: 36 weeks pregnancy
Other	T1 Dosage received - time spent on EXERCISE component	Participant time spent on EXERCISE component (hours and minutes)	Collected at T1: 36 weeks pregnancy
Other	T1 Dosage received - time spent on MENTAL HEALTH component	Participant time spent on MENTAL HEALTH component (hours and minutes)	Collected at T1: 36 weeks pregnancy
Other	T3 Dosage received - time spent on DIET component	Time spent on DIET component (hours and minutes)	Collected at T3: 6months after delivery
Other	T3 Dosage received - time spent on EXERCISE component	Time spent on EXERCISE component (hours and minutes)	Collected at T3: 6months after delivery
Other	T3 Dosage received - time spent on MENTAL HEALTH component	Time spent on MENTAL HEALTH component (hours and minutes)	Collected at T3: 6months after delivery
Other	T5 Dosage received - time spent on DIET component	Time spent on DIET component (hours and minutes)	Collected at T5: 12 months after delivery
Other	T5 Dosage received - time spent on EXERCISE component	Time spent on EXERCISE component (hours and minutes)	Collected at T5: 12 months after delivery
Other	T5 Dosage received - time spent on MENTAL HEALTH component	Time spent on MENTAL HEALTH component (hours and minutes)	Collected at T5: 12 months after delivery
Other	Fidelity at T1	This is an assessment of the researcher in the team to check on the research dietitian's in delivering group support according to a pre-specified plan. This will be reported descriptively.	collected at T1: 36 weeks pregnancy
Other	Fidelity at T3	This is an assessment of the researcher in the team to check on the research dietitian's in delivering group support according to a pre-specified plan. This will be reported descriptively.	collected at T3: 6 months after delivery
Other	Fidelity at T5	This is an assessment of the researcher in the team to check on the research dietitian's in delivering group support according to a pre-specified plan. This will be reported descriptively.	collected at T5: 12 months after delivery
Other	Semi-structured interview at T1	Interviews on participant experiences and satisfaction towards the intervention	Collected at T1: 36 weeks pregnancy
Other	Semi-structured interview at T3	Interviews on participant experiences and satisfaction towards the intervention	Collected at T3: 6 months after delivery
Other	Semi-structured interview at T5	Interviews on participant experiences and satisfaction towards the intervention	Collected at T5: 12 months after delivery
Other	Mother infant relationship at T2	3-minutes video recording captured through Zoom and coded based on the CARE-INDEX	Collected at T2: 3 months after delivery
Other	Satisfaction survey at T5	acceptability, experience and perceived usefulness of the project	Collected at T5: 12 months after delivery
Other	Hypertension	This is a diagnosis by the clinic and reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Hypercholesterolemia	This is a diagnosis by the clinic and reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Delivery method	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Pregnancy complications	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Birth complications	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Breastfeeding status on discharge	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Neonatal birth weight	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Neonatal APGAR score 5 minutes	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Congenital anomaly	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Congenital pnuemonia / heart defects	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Admission to neonatal intensive care	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Other	Length of stay at the hospital ward	This is reported in the record from anytime after delivery to 3 months postpartum.	Collected at T2: 3 months postpartum
Primary	Number of women who were randomised to the treatment groups.	The proportion of women who were randomised (numerator) out of those identified from the clinical registers (study population as denominator)	Collected antenatally at 30 weeks pregnancy
Primary	Number of women that take up the intervention	The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator)	Collected antenatally at 36 weeks pregnancy
Primary	Number of women that take up the intervention	The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator)	Collected antenatally at 6 months after delivery.
Primary	Number of women that take up the intervention	The proportion of women who take up the intervention (numerator) out of those in the intervention arm (denominator)	Collected antenatally at 12 months after delivery.
Primary	Number of women withdrawn or loss to follow up	The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 36 weeks pregnancy
Primary	Number of women withdrawn or loss to follow up	The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 3 months after delivery
Primary	Number of women withdrawn or loss to follow up	The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 6 months after delivery
Primary	Number of women withdrawn or loss to follow up	The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 9 months after delivery
Primary	Number of women withdrawn or loss to follow up	The proportion of women who are withdrawn or lost to follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 12 months after delivery
Secondary	Number of women consented	The proportion of women who give consent for screening eligibility (numerator) out of those identified from clinical registers (denominator)	Collected antenatally at 24-28 weeks pregnancy
Secondary	Number of women randomised	The proportion of women who were randomised (numerator) out of those eligible to participate (denominator)	Collected antenatally at 24-28 weeks pregnancy
Secondary	Number of women completed the secondary outcomes	The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 36 weeks pregnancy
Secondary	Number of women completed the secondary outcomes	The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 3 months after delivery
Secondary	Number of women completed the secondary outcomes	The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 6 months after delivery
Secondary	Number of women completed the secondary outcomes	The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 9 months after delivery
Secondary	Number of women completed the secondary outcomes	The proportion of those who completed the secondary outcomes at follow-up (numerator) out of those randomised (denominator)	Collected antenatally at 12 months after delivery
Secondary	Number of women randomised	The number of women randomised per month overall, and per month per study site.	Collected antenatally at 30 weeks pregnancy

External Links

•   UKRI website about the project