An interventional study of MyManis app in Gestational Diabetes, GDM and Pregnancy-Induced Diabetes, sponsored by Universiti Putra Malaysia. Status unknown at 3 sites in Malaysia. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Supportive care
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.
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 60 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Universiti Putra Malaysia is the lead sponsor of 144 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Women who meet study inclusion criteria and consent to study participation will be randomised using sealed envelope randomisation and online database for clinical trials to one of two groups in a 1:1 ratio.
Other: MyManis app
Women allocated to the control arm will receive standard care and no digital intervention. This includes self-monitoring blood glucose and lifestyle advice (diet, physical activity, optimal body weight) by a multidisciplinary team.
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.
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)
Time frame: Collected antenatally at 30 weeks pregnancy
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)
Time frame: Collected antenatally at 36 weeks pregnancy
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)
Time frame: Collected antenatally at 6 months after delivery.
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)
Time frame: Collected antenatally at 12 months after delivery.
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)
Time frame: Collected antenatally at 36 weeks pregnancy
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)
Time frame: Collected antenatally at 3 months after delivery
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)
Time frame: Collected antenatally at 6 months after delivery
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)
Time frame: Collected antenatally at 9 months after delivery
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)
Time frame: Collected antenatally at 12 months after delivery
Number of women consented
The proportion of women who give consent for screening eligibility (numerator) out of those identified from clinical registers (denominator)
Time frame: Collected antenatally at 24-28 weeks pregnancy
Number of women randomised
The proportion of women who were randomised (numerator) out of those eligible to participate (denominator)
Time frame: Collected antenatally at 24-28 weeks pregnancy
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)
Time frame: Collected antenatally at 36 weeks pregnancy
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)
Time frame: Collected antenatally at 3 months after delivery
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)
Time frame: Collected antenatally at 6 months after delivery
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)
Time frame: Collected antenatally at 9 months after delivery
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)
Time frame: Collected antenatally at 12 months after delivery
Number of women randomised
The number of women randomised per month overall, and per month per study site.
Time frame: Collected antenatally at 30 weeks pregnancy
Body weight at T0
Weight (kg)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Body weight at T1
Weight (kg)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
Body weight at T2
Weight (kg)
Time frame: Collected antenatally at T2: 3 months after delivery
Body weight at T3
Weight (kg)
Time frame: Collected antenatally at T3: 6 months after delivery
Body weight at T4
Weight (kg)
Time frame: Collected antenatally at T4: 9 months after delivery
Body weight at T5
Weight (kg)
Time frame: Collected antenatally at T5: 12 months after delivery
Height at T0
measured for 1 time only (in centimetres, cm)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Body mass index at T0
calculated as body weight divided by (heightxheight) (kg/m\^2)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Body mass index at T1
calculated as body weight divided by (heightxheight) (kg/m\^2)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
Body mass index at T2
calculated as body weight divided by (heightxheight) (kg/m\^2)
Time frame: Collected antenatally at T2: 3 months after delivery
Body mass index at T3
calculated as body weight divided by (heightxheight) (kg/m\^2)
Time frame: Collected antenatally at T3: 6 months after delivery
Body mass index at T4
calculated as body weight divided by (heightxheight) (kg/m\^2)
Time frame: Collected antenatally at T4: 9 months after delivery
Body mass index at T5
calculated as body weight divided by (heightxheight) (kg/m\^2)
Time frame: Collected antenatally at T5: 12 months after delivery
Body fat percentage at T0
Body fat percentage reported in % (to 1 decimal point)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Body fat percentage at T1
Body fat percentage reported in % (to 1 decimal point)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
Body fat percentage at T2
Body fat percentage reported in % (to 1 decimal point)
Time frame: Collected antenatally at T2: 3 months after delivery
Body fat percentage at T3
Body fat percentage reported in % (to 1 decimal point)
Time frame: Collected antenatally at T3: 6 months after delivery
Body fat percentage at T4
Body fat percentage reported in % (to 1 decimal point)
Time frame: Collected antenatally at T4: 9 months after delivery
Body fat percentage at T5
Body fat percentage reported in % (to 1 decimal point)
Time frame: Collected antenatally at T5: 12 months after delivery
Blood pressure reading at T0
measure systolic and diastolic blood pressure (mmHg)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Blood pressure reading at T1
measure systolic and diastolic blood pressure (mmHg)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
Blood pressure reading at T3
measure systolic and diastolic blood pressure (mmHg)
Time frame: Collected antenatally at T3: 6 months after delivery
Blood pressure reading at T5
measure systolic and diastolic blood pressure (mmHg)
Time frame: Collected antenatally at T5: 12 months after delivery
Total Cholestrol at T0
Total Cholestrol (mmol/L)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Total Cholestrol at T1
Total Cholestrol (mmol/L)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
Total Cholestrol at T3
Total Cholestrol (mmol/L)
Time frame: Collected antenatally at T3: 6 months after delivery
Total Cholestrol at T5
Total Cholestrol (mmol/L)
Time frame: Collected antenatally at T5: 12 months after delivery
Low Density Lipoprotein Cholestrol at T0
Low Density Lipoprotein Cholestrol, LDL (mmol/L)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Low Density Lipoprotein Cholestrol at T1
Low Density Lipoprotein Cholestrol, LDL (mmol/L)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
Low Density Lipoprotein Cholestrol at T3
Low Density Lipoprotein Cholestrol, LDL (mmol/L)
Time frame: Collected antenatally at T3: 6 months after delivery
Low Density Lipoprotein Cholestrol at T5
Low Density Lipoprotein Cholestrol, LDL (mmol/L)
Time frame: Collected antenatally at T5: 12 months after delivery
High Density Lipoprotein cholesterol at T0
High Density Lipoprotein cholesterol, HDL (mmol/L)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
High Density Lipoprotein cholesterol at T1
High Density Lipoprotein cholesterol, HDL (mmol/L)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
High Density Lipoprotein cholesterol at T3
High Density Lipoprotein cholesterol, HDL (mmol/L)
Time frame: Collected antenatally at T3: 6 months after delivery
High Density Lipoprotein cholesterol at T5
High Density Lipoprotein cholesterol, HDL (mmol/L)
Time frame: Collected antenatally at T5: 12 months after delivery
HbA1c at T0
HbA1c (%)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
HbA1c at T1
HbA1c (%)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
HbA1c at T3
HbA1c (%)
Time frame: Collected antenatally at T3: 6 months after delivery
HbA1c at T5
HbA1c (%)
Time frame: Collected antenatally at T5: 12 months after delivery
Fasting blood glucose at T0
Fasting blood glucose (mmol/l)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Fasting blood glucose at T1
Fasting blood glucose (mmol/l)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
Oral glucose tolerance test (OGTT) Fasting at T3
Oral glucose tolerance test (OGTT) Fasting (mmol/l)
Time frame: Collected antenatally at T3: 6 months after delivery
Oral glucose tolerance test (OGTT) Fasting at T5
Oral glucose tolerance test (OGTT) Fasting (mmol/l)
Time frame: Collected antenatally at T5: 12 months after delivery
Oral glucose tolerance test (OGTT) 2-hour Postprandial at T3
Oral glucose tolerance test (OGTT) 2-hour Postprandial (mmol/l)
Time frame: Collected antenatally at T3: 6 months after delivery
Oral glucose tolerance test (OGTT) 2-hour Postprandial at T5
Oral glucose tolerance test (OGTT) 2-hour Postprandial (mmol/l)
Time frame: Collected antenatally at T5: 12 months after delivery
Fasting Serum Insulin at T0
Fasting Serum Insulin (U/mL)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Fasting Serum Insulin at T1
Fasting Serum Insulin (U/mL)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
Fasting Serum Insulin at T3
Fasting Serum Insulin (U/mL)
Time frame: Collected antenatally at T3: 6 months after delivery
Fasting Serum Insulin at T5
Fasting Serum Insulin (U/mL)
Time frame: Collected antenatally at T5: 12 months after delivery
Insulin resistance at T0
Insulin resistance (HOMA-IR)
Time frame: Collected antenatally at T0: 30 weeks pregnancy
Insulin resistance at T1
Insulin resistance (HOMA-IR)
Time frame: Collected antenatally at T1: 36 weeks pregnancy
Insulin resistance at T3
Insulin resistance (HOMA-IR)
Time frame: Collected antenatally at T3: 6 months after delivery
Insulin resistance at T5
Insulin resistance (HOMA-IR)
Time frame: Collected antenatally at T5: 12 months after delivery
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.
Time frame: Collected at T0: 30 weeks pregnancy
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.
Time frame: Collected at T3: 6 months after delivery
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.
Time frame: Collected at T5: 12 months after delivery
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.
Time frame: Collected at 30 weeks pregnancy
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.
Time frame: Collected at 6 months after delivery
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.
Time frame: Collected at 12 months after delivery
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.
Time frame: Collected at T0: 30 weeks pregnancy
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.
Time frame: Collected at T3: 6 months after delivery
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.
Time frame: Collected at T5: 12 months after delivery
Dietary intake at T0
Total macronutrient intake from standardised multiple-pass 24-hour dietary recall)
Time frame: Collected at T0: 30 weeks pregnancy
Dietary intake at T3
Total macronutrient intake from standardised multiple-pass 24-hour dietary recall)
Time frame: Collected at T3: 6 months after delivery
Dietary intake at T5
Total macronutrient intake from standardised multiple-pass 24-hour dietary recall)
Time frame: Collected at T5: 12 months after delivery
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.
Time frame: Collected at T0: 30 weeks pregnancy
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.
Time frame: Collected at T3: 6 months after delivery
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.
Time frame: Collected at T5: 12 months after delivery
mean step count at T0
Number of steps in inbuild smartphone app
Time frame: Collected at T0: 30 weeks pregnancy
mean step count at T3
Number of steps in inbuild smartphone app
Time frame: Collected at T3: 6 months after delivery
mean step count at T5
Number of steps in inbuild smartphone app
Time frame: Collected at T5: 12 months after delivery
Infant feeding T3
Type of feeding status
Time frame: Collected at T3: 6 months after delivery
Infant feeding at T5
Type of feeding status
Time frame: Collected at T5: 12 months after delivery
Alcohol intake at T0
Frequency of intake
Time frame: Collected at T0: 30 weeks pregnancy
Alcohol intake at T3
Frequency of intake
Time frame: Collected at T3: 6 months after delivery
Alcohol intake at T5
Frequency of intake
Time frame: Collected at T5: 12 months after delivery
Smoking status at T0
type of smoker
Time frame: Collected at T0: 30 weeks pregnancy
Smoking status at T3
type of smoker
Time frame: Collected at T3: 6 months after delivery
Smoking status at T5
type of smoker
Time frame: Collected at T5: 12 months after delivery
Recruitment rate
number of eligible, consented, screened, enrolled, and randomised
Time frame: Collected at 30 weeks pregnancy
T1 Dosage delivered - app download
The number of MyManis app delivered by the researcher and the number of app downloads (n) by the participant.
Time frame: Collected at T1: 36 weeks pregnancy
T3 Dosage delivered - app download
The number of MyManis app delivered by the researcher and the number of app downloads (n) by the participant.
Time frame: Collected at T3: 6 months after delivery
T5 Dosage delivered - app download
The number of MyManis app delivered by the researcher and the number of app downloads (n) by the participant.
Time frame: Collected at T5: 12 months after delivery
T1 Dosage delivered - Support group
Total number of group support sessions (n) planned to deliver by the dietitian train in motivational interviewing.
Time frame: Collected at T1: 36 weeks pregnancy
T3 Dosage delivered - Support group
Total number of group support sessions (n) planned to deliver by the dietitian train in motivational interviewing.
Time frame: Collected at T3: 6 months after delivery
T5 Dosage delivered - Support group
Total number of group support sessions (n) planned to deliver by the dietitian train in motivational interviewing.
Time frame: Collected at T5: 12 months after delivery
T1 Dosage received - Participant's engagement
The number of participant log into MyManis app per month (n)
Time frame: Collected at T1: 36 weeks pregnancy
T3 Dosage received - Participant's engagement
The number of participant log into MyManis app per month (n)
Time frame: Collected at T3: 6 months after delivery
T5 Dosage received - Participant's engagement
The number of participant log into MyManis app per month (n)
Time frame: Collected at T5: 12 months after delivery
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)
Time frame: Collected at T1: 36 weeks pregnancy
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)
Time frame: Collected at T3: 6 months after delivery
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)
Time frame: Collected at T5: 12 months after delivery
T1 Dosage received - time spent on DIET component
Participant time spent on DIET component (hours and minutes)
Time frame: Collected at T1: 36 weeks pregnancy
T1 Dosage received - time spent on EXERCISE component
Participant time spent on EXERCISE component (hours and minutes)
Time frame: Collected at T1: 36 weeks pregnancy
T1 Dosage received - time spent on MENTAL HEALTH component
Participant time spent on MENTAL HEALTH component (hours and minutes)
Time frame: Collected at T1: 36 weeks pregnancy
T3 Dosage received - time spent on DIET component
Time spent on DIET component (hours and minutes)
Time frame: Collected at T3: 6months after delivery
T3 Dosage received - time spent on EXERCISE component
Time spent on EXERCISE component (hours and minutes)
Time frame: Collected at T3: 6months after delivery
T3 Dosage received - time spent on MENTAL HEALTH component
Time spent on MENTAL HEALTH component (hours and minutes)
Time frame: Collected at T3: 6months after delivery
T5 Dosage received - time spent on DIET component
Time spent on DIET component (hours and minutes)
Time frame: Collected at T5: 12 months after delivery
T5 Dosage received - time spent on EXERCISE component
Time spent on EXERCISE component (hours and minutes)
Time frame: Collected at T5: 12 months after delivery
T5 Dosage received - time spent on MENTAL HEALTH component
Time spent on MENTAL HEALTH component (hours and minutes)
Time frame: Collected at T5: 12 months after delivery
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.
Time frame: collected at T1: 36 weeks pregnancy
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.
Time frame: collected at T3: 6 months after delivery
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.
Time frame: collected at T5: 12 months after delivery
Semi-structured interview at T1
Interviews on participant experiences and satisfaction towards the intervention
Time frame: Collected at T1: 36 weeks pregnancy
Semi-structured interview at T3
Interviews on participant experiences and satisfaction towards the intervention
Time frame: Collected at T3: 6 months after delivery
Semi-structured interview at T5
Interviews on participant experiences and satisfaction towards the intervention
Time frame: Collected at T5: 12 months after delivery
Mother infant relationship at T2
3-minutes video recording captured through Zoom and coded based on the CARE-INDEX
Time frame: Collected at T2: 3 months after delivery
Satisfaction survey at T5
acceptability, experience and perceived usefulness of the project
Time frame: Collected at T5: 12 months after delivery
Hypertension
This is a diagnosis by the clinic and reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Hypercholesterolemia
This is a diagnosis by the clinic and reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Delivery method
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Pregnancy complications
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Birth complications
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Breastfeeding status on discharge
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Neonatal birth weight
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Neonatal APGAR score 5 minutes
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Congenital anomaly
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Congenital pnuemonia / heart defects
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Admission to neonatal intensive care
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Length of stay at the hospital ward
This is reported in the record from anytime after delivery to 3 months postpartum.
Time frame: Collected at T2: 3 months postpartum
Plan to share: No
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Universiti Putra Malaysia