PregnancyNCT04216446
Mobile Health (m-Health) Coaching Program During Pregnancy
A study testing Mobile Health Intervention in people with Pregnancy, run by Aga Khan University at 1 site in Pakistan.
Trial summary
A parallel-group randomized controlled trial that will evaluate the efficacy of a mobile health (m-Health) program on influencing diet, supplement use and physical activity during pregnancy. Pregnant women will be randomly assigned to the intervention and the non-intervention arm. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Mobile Health Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jan 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women 18 years and above in their first trimester
- Enrolled at antenatal clinics of The Aga Khan University Hospital, Karachi
- Pregnant women who have personal smartphones with internet connections.
- Eligible subjects who consent to participate and agree to remain in the study until the first year of the birth of the baby.
Who cannot join
- Pregnant women who have co-morbidity such as cardiovascular disease, diabetes, liver or kidney disease or autoimmune disorder (SLE)
- Pregnant women who are on dietary control due to co-morbid conditions.
- Pregnant women who are on platelet aggregates, hypoglycemic or anti-hypertensive drugs.
- Pregnant women who are unable to read and write due to the language barrier.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Personalized Mobile-Health Coaching Program During Pregnancy on Maternal Diet, Supplement Use and Physical Activity: a Parallel-Group Randomized Controlled Trial
A parallel-group randomized controlled trial that will evaluate the efficacy of a mobile health (m-Health) program on influencing diet, supplement use and physical activity during pregnancy. Pregnant women will be randomly assigned to the intervention and the non-intervention arm. The intervention arm will receive free of cost m-Health application that will screen on the diet, supplement use and physical activity at enrollment and at 4 follow-ups, each 6 weeks apart. Based on the information provided by women, they will receive personalised recommendations based on an algorithm developed using the World Health Organization's guidelines on nutrition during pregnancy and American College of Obstetricians and Gynaecologists guidelines for physical activity during pregnancy. The non-intervention arm will receive standard face-face counselling. The changes in diet and supplement use of both groups will be assessed using the Dietary Risk Score. Also, biochemical assessment of micronutrients will be carried out on a subset. the change in physical activity will be assessed by the mean duration of reported activity. The secondary outcomes include the evaluation of compliance and usability of the m-Health application. Also, the effect of the m-Health application on maternal, newborn and infant outcomes will be assessed.
Read the detailed description
A parallel-group randomized controlled trial will be implemented with pregnant women at the antenatal clinics of the Aga Khan University Hospital (AKUH) Karachi. Pregnant women in their first trimester, registered or planning to register at AKUH with access to personal smartphones with internet connection will be considered eligible for the study. For pregnant women in the intervention arm, mobile health application will be provided on their smartphones that will screen their socio-demographic characteristics, diet and supplement use and physical activity habits. Based on the information provided by women, personalized recommendations and a dietary risk score will be generated upon completion of the questionnaire. A similar process will be repeated on 4 follow-ups, each 6 weeks apart after enrollment in the study. Also, push notifications consisting of tips and recommendations will be sent to women a maximum of 3 times a week on dietary, supplement use and physical activity. The women in the non-intervention arm will be provided with standard face-face counselling at similar time points as of intervention group, using the bilingual educational leaflet of the Aga Khan University Hospital "Diet during Pregnancy" and the American College of Obstetricians and Gynaecologists guidelines for physical activity during pregnancy. The primary outcome of the study is improvement in the dietary and supplement use that will be assessed through Dietary Risk Score. A selective subset of participants from both the group will undergo free of cost biochemical assessment micronutrients (serum calcium, vitamin D, iron and folate). The secondary outcomes include assessing the compliance and usability of m-Health application among the pregnant women enrolled in the intervention arm. Other secondary outcomes include evaluating the effect of m-Health coaching on maternal, newborn and infant outcomes among pregnant women in the intervention arm compared to the pregnant women in the non-intervention arm
- Conditions
- Pregnancy
- Being tested
- Mobile Health Intervention
- Keywords
- m-Health coaching, Pregnancy, Diet, Supplement use, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health InterventionBehavioural
A mobile based application will be developed that will function on android as well as the iPhone operating system. The application will be provided to eligible pregnant women randomized to the intervention group. The dietary, supplement use and physical activity coaching will be provided over the period of 6 months through the application.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health Coaching Program during pregnancy | Experimental | Eligible pregnant women would be randomized to intervention or the non-intervention arm after consenting to participate. Participants in the intervention arm will receive free subscription of m-Health program for six months of coaching. The program will provide individualized coaching on diet, supplement use and physical activity. Participants would undergo dietary screening at five points i.e. at baseline and at 6, 12, 18 and 24 weeks follow-up to monitor the improvement (if any) in diet, supplement use and physical activity. Women will receive advice in the form of recommendations after completing the questionnaire. Also, push messages containing tips and recommendations for diet, supplement use and physical activity would be delivered a maximum of three times a week. Furthermore, a subset of participants would undergo objective dietary assessment through biochemical testing of serum folate, serum ferritin, and serum calcium and serum vitamin D at baseline and at end line. Receives: Behavioral: Mobile Health Intervention |
| Standard Counseling | No intervention | For the non-intervention arm, dietary counseling will be provided face to face by the trained research assistant at the baseline and scheduled follow-ups using the AKUH educational leaflet "Diet during Pregnancy" and American College of obstetricians and gynaecologists guidelines for physical activity. Alike intervention group, the non-intervention group will complete an interviewer based paperless screening questionnaire at five points i.e. at baseline and at 6, 12, 18 and 24 weeks follow up. Furthermore, a subset of participants would undergo objective dietary assessment through biochemical testing of serum folate, serum ferritin, and serum calcium and serum vitamin D at baseline and at end line. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Risk Score (DRS)
Dietary Risk Scores (DRSs) will be calculated based on the consumption of food items from six main food groups and will range from 0-18. Based on the portions and quality of diet, the score for each group will be 0, 1.5 or 3. The total score will be the sum of individual group scores. Higher the aggregate score, poorer the dietary quantity and quality and vice versa. Hence, a score of 18 will indicate a highly inadequate dietary intake; a score of 9 denotes nearly adequate and a score of 0, an adequate diet.
Measured: 6 months, from enrollment till last follow-up
Supplement use Score
Supplement use will be assessed by recording the frequency of consumption of folic acid, iron, calcium and vitamin D in the questionnaire. The frequency will be categorized as daily (7 days a week), often (4-6 days a week) and sometimes (1-3 days a week). Also, a total score ranging from 0-12 will be assigned where each supplement use will be scored 0 for daily, 1.5 for less than daily and 3 for no consumption. The total score will be the sum of each supplement score and will be monitored at each follow-up.
Measured: 6 months, from enrollment till last follow-up
Biochemical Assessment of serum folate at baseline
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum folate at the baseline screening
Measured: 1 week of enrollment
Biochemical Assessment of serum ferritin at baseline
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum ferritin at the baseline screening
Measured: 1 week of enrollment
Biochemical Assessment of serum calcium at baseline
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum calcium at the baseline screening
Measured: 1 week of enrollment
Biochemical Assessment of vitamin D at baseline
A subset of pregnant women from each group will be selected systematically for the biochemical testing of vitamin D levels at the baseline screening
Measured: 1 week of enrollment
Biochemical Assessment of serum folate at endline screening
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum folate at the end line screening.
Measured: 24 week of enrollment
Biochemical Assessment of serum ferritin at endline screening
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum ferritin at the end line screening.
Measured: 24 week of enrollment
Biochemical Assessment of serum calcium at endline screening
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum calcium at the end line screening.
Measured: 24 week of enrollment
Biochemical Assessment of Vitamin D at endline screening
A subset of pregnant women from each group will be selected systematically for the biochemical testing of vitamin D levels at the end line screening.
Measured: 24 week of enrollment
Physical activity
Intensity and duration (minutes) of physical activity will be assessed through the questionnaire at baseline and each follow-up. Household tasks such as cooking, ironing, light physical work, driving and washing dishes will be categorized as mild activities. Brisk walking, gardening, house hold chores such as sweeping, washing, mopping, actively playing with children and carrying loads <20kg will be classified as moderate intensity activities. On the other hand, vigorous intensity activities will include running, fast cycling, aerobics, swimming, sports games or carrying load >20 kg.
Measured: 6 months, from enrollment till last follow-up
Secondary outcomes (11)
Compliance with the intervention
Percentage of participants who would complete the six months' program.
Measured: 24 week of enrollment
Usability of mobile health program
Usability of the web-based program will be assessed at the end of the study using a digital evaluation form containing 26 questions with a five response categories Likert-type scale as strongly agree, agree, neutral, disagree and strongly disagree OR always, often, sometimes, rarely and never. it will be assessed under three categories: (i) design and interface, (ii) content and coaching and (iii) perception and personal benefit.
Measured: 24 week of enrollment
Maternal health outcomes: Pre-eclampsia
new onset of hypertension after 20 weeks of gestation along with proteinuria (a spot urine protein/creatinine ratio of ≥30 mg per mmol) and/or evidence of maternal acute kidney injury, liver dysfunction, neurological features, hemolysis or thrombocytopenia, and/or fetal growth restriction.
Measured: Through study completion, average of 1 year
Maternal health outcomes: Gestational hypertension
New onset of hypertension i.e. blood pressure ≥140 mmHg systolic or ≥90 mmHg diastolic at or after 20 weeks' gestation
Measured: Through study completion, average of 1 year
Maternal health outcomes: Gestational Diabetes
Diagnosis made by a single-step 75-g oral glucose tolerance test conducted between 24 and 28 weeks of gestation or at any other time, with one or more of the following results: (1) Fasting plasma glucose 5.1-6.9 mmol/L (92-125 mg/dL); (2) 1-hour post 75-g oral glucose load ≥10 mmol/L (180 mg/dL); (3) 2-hour post 75-g oral glucose load 8.5-11.0 mmol/L (153-199 mg/dL)
Measured: Through study completion, average of 1 year
Maternal health outcomes: Gestational weight gain during first, second and third trimester
Gestational weight gain (GWG) will be determined from weights recorded during the first, second and third trimester. Centiles and z-scores would be assessed using the international gestational weight gain calculator based on the INTERGROWTH-21st standards for gestational weight gain
Measured: Through study completion, average of 1 year
Newborn birth weight
Newborn birth weight in grams adjusted for gestational age at birth will be compared with INTERGROWTH-21st standards.
Measured: Through study completion, average of 1 year
Newborn length
Newborn length in cm adjusted for gestational age at birth will be compared with INTERGROWTH-21st standards.
Measured: Through study completion, average of 1 year
Preterm birth
Preterm births will defined as spontaneous births before completed 37 weeks of gestation.
Measured: Through study completion, average of 1 year
Infant's Blood Pressure at 1 year
Resting blood pressure (BP) would be assessed at 12 month age, after the infant had been calm for >3 min. Mean Systolic and Diastolic BP more than 90th centile appropriate for the height centile and gender will be considered high risk.
Measured: 1 year of infant's age
Infant's Body Mass Index
Infant's weight and length will be assessed at 12 month age.
Measured: 1 year of infant's age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start13 Jan 2020
- Primary completion30 Sep 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rozina Nuruddin, Aga Khan University
- Investigators
- Rozina Nuruddin, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216446
- Sponsor's protocol ID
- 2019-0757-2504
- Status last verified
- Jul 2024
- First submitted
- 20 Dec 2019
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vadsaria K, Nuruddin R, Mohammed N, Azam I, Sayani S. Efficacy of a Personalized mHealth App in Improving Micronutrient Supplement Use Among Pregnant Women in Karachi, Pakistan: Parallel-Group Randomized Controlled Trial. J Med Internet Res. 2025 Apr 9;27:e67166. doi: 10.2196/67166.
PubMed 40203301Nuruddin R, Vadsaria K, Mohammed N, Sayani S. The Efficacy of a Personalized mHealth Coaching Program During Pregnancy on Maternal Diet, Supplement Use, and Physical Activity: Protocol for a Parallel-Group Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 16;10(11):e31611. doi: 10.2196/31611.
PubMed 34783675
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Personalized Mobile-Health Coaching Program During Pregnancy on Maternal Diet, Supplement Use and Physical Activity: a Parallel-Group Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04216446
- Acronym / sponsor ID
- 2019-0757-2504
- Conditions
- Pregnancy
- Keywords
- m-Health coaching, Pregnancy, Diet, Supplement use, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A parallel-group randomized controlled trial that will evaluate the efficacy of a mobile health (m-Health) program on influencing diet, supplement use and physical activity during pregnancy. Pregnant women will be randomly assigned to the intervention and the non-intervention arm. The intervention arm will receive free of cost m-Health application that will screen on the diet, supplement use and physical activity at enrollment and at 4 follow-ups, each 6 weeks apart. Based on the information provided by women, they will receive personalised recommendations based on an algorithm developed using the World Health Organization's guidelines on nutrition during pregnancy and American College of Obstetricians and Gynaecologists guidelines for physical activity during pregnancy. The non-intervention arm will receive standard face-face counselling. The changes in diet and supplement use of both groups will be assessed using the Dietary Risk Score. Also, biochemical assessment of micronutrients will be carried out on a subset. the change in physical activity will be assessed by the mean duration of reported activity. The secondary outcomes include the evaluation of compliance and usability of the m-Health application. Also, the effect of the m-Health application on maternal, newborn and infant outcomes will be assessed.
Detailed description
A parallel-group randomized controlled trial will be implemented with pregnant women at the antenatal clinics of the Aga Khan University Hospital (AKUH) Karachi. Pregnant women in their first trimester, registered or planning to register at AKUH with access to personal smartphones with internet connection will be considered eligible for the study. For pregnant women in the intervention arm, mobile health application will be provided on their smartphones that will screen their socio-demographic characteristics, diet and supplement use and physical activity habits. Based on the information provided by women, personalized recommendations and a dietary risk score will be generated upon completion of the questionnaire. A similar process will be repeated on 4 follow-ups, each 6 weeks apart after enrollment in the study. Also, push notifications consisting of tips and recommendations will be sent to women a maximum of 3 times a week on dietary, supplement use and physical activity. The women in the non-intervention arm will be provided with standard face-face counselling at similar time points as of intervention group, using the bilingual educational leaflet of the Aga Khan University Hospital "Diet during Pregnancy" and the American College of Obstetricians and Gynaecologists guidelines for physical activity during pregnancy. The primary outcome of the study is improvement in the dietary and supplement use that will be assessed through Dietary Risk Score. A selective subset of participants from both the group will undergo free of cost biochemical assessment micronutrients (serum calcium, vitamin D, iron and folate). The secondary outcomes include assessing the compliance and usability of m-Health application among the pregnant women enrolled in the intervention arm. Other secondary outcomes include evaluating the effect of m-Health coaching on maternal, newborn and infant outcomes among pregnant women in the intervention arm compared to the pregnant women in the non-intervention arm
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Health Coaching Program during pregnancy | Experimental | Behavioral: Mobile Health InterventionEligible pregnant women would be randomized to intervention or the non-intervention arm after consenting to participate. Participants in the intervention arm will receive free subscription of m-Health program for six months of coaching. The program will provide individualized coaching on diet, supplement use and physical activity. Participants would undergo dietary screening at five points i.e. at baseline and at 6, 12, 18 and 24 weeks follow-up to monitor the improvement (if any) in diet, supplement use and physical activity. Women will receive advice in the form of recommendations after completing the questionnaire. Also, push messages containing tips and recommendations for diet, supplement use and physical activity would be delivered a maximum of three times a week. Furthermore, a subset of participants would undergo objective dietary assessment through biochemical testing of serum folate, serum ferritin, and serum calcium and serum vitamin D at baseline and at end line. |
| Standard Counseling | No intervention | –For the non-intervention arm, dietary counseling will be provided face to face by the trained research assistant at the baseline and scheduled follow-ups using the AKUH educational leaflet "Diet during Pregnancy" and American College of obstetricians and gynaecologists guidelines for physical activity. Alike intervention group, the non-intervention group will complete an interviewer based paperless screening questionnaire at five points i.e. at baseline and at 6, 12, 18 and 24 weeks follow up. Furthermore, a subset of participants would undergo objective dietary assessment through biochemical testing of serum folate, serum ferritin, and serum calcium and serum vitamin D at baseline and at end line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women 18 years and above in their first trimester
- Enrolled at antenatal clinics of The Aga Khan University Hospital, Karachi
- Pregnant women who have personal smartphones with internet connections.
- Eligible subjects who consent to participate and agree to remain in the study until the first year of the birth of the baby.
Key exclusion criteria (4 listed)
- Pregnant women who have co-morbidity such as cardiovascular disease, diabetes, liver or kidney disease or autoimmune disorder (SLE)
- Pregnant women who are on dietary control due to co-morbid conditions.
- Pregnant women who are on platelet aggregates, hypoglycemic or anti-hypertensive drugs.
- Pregnant women who are unable to read and write due to the language barrier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health InterventionA mobile based application will be developed that will function on android as well as the iPhone operating system. The application will be provided to eligible pregnant women randomized to the intervention group. The dietary, supplement use and physical activity coaching will be provided over the period of 6 months through the application. | Behavioural | Mobile Health Coaching Program during pregnancy |
Primary outcome
Dietary Risk Score (DRS)
Time frame: 6 months, from enrollment till last follow-up
Dietary Risk Scores (DRSs) will be calculated based on the consumption of food items from six main food groups and will range from 0-18. Based on the portions and quality of diet, the score for each group will be 0, 1.5 or 3. The total score will be the sum of individual group scores. Higher the aggregate score, poorer the dietary quantity and quality and vice versa. Hence, a score of 18 will indicate a highly inadequate dietary intake; a score of 9 denotes nearly adequate and a score of 0, an adequate diet.
Supplement use Score
Time frame: 6 months, from enrollment till last follow-up
Supplement use will be assessed by recording the frequency of consumption of folic acid, iron, calcium and vitamin D in the questionnaire. The frequency will be categorized as daily (7 days a week), often (4-6 days a week) and sometimes (1-3 days a week). Also, a total score ranging from 0-12 will be assigned where each supplement use will be scored 0 for daily, 1.5 for less than daily and 3 for no consumption. The total score will be the sum of each supplement score and will be monitored at each follow-up.
Biochemical Assessment of serum folate at baseline
Time frame: 1 week of enrollment
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum folate at the baseline screening
Biochemical Assessment of serum ferritin at baseline
Time frame: 1 week of enrollment
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum ferritin at the baseline screening
Biochemical Assessment of serum calcium at baseline
Time frame: 1 week of enrollment
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum calcium at the baseline screening
Biochemical Assessment of vitamin D at baseline
Time frame: 1 week of enrollment
A subset of pregnant women from each group will be selected systematically for the biochemical testing of vitamin D levels at the baseline screening
Biochemical Assessment of serum folate at endline screening
Time frame: 24 week of enrollment
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum folate at the end line screening.
Biochemical Assessment of serum ferritin at endline screening
Time frame: 24 week of enrollment
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum ferritin at the end line screening.
Biochemical Assessment of serum calcium at endline screening
Time frame: 24 week of enrollment
A subset of pregnant women from each group will be selected systematically for the biochemical testing of serum calcium at the end line screening.
Biochemical Assessment of Vitamin D at endline screening
Time frame: 24 week of enrollment
A subset of pregnant women from each group will be selected systematically for the biochemical testing of vitamin D levels at the end line screening.
Physical activity
Time frame: 6 months, from enrollment till last follow-up
Intensity and duration (minutes) of physical activity will be assessed through the questionnaire at baseline and each follow-up. Household tasks such as cooking, ironing, light physical work, driving and washing dishes will be categorized as mild activities. Brisk walking, gardening, house hold chores such as sweeping, washing, mopping, actively playing with children and carrying loads <20kg will be classified as moderate intensity activities. On the other hand, vigorous intensity activities will include running, fast cycling, aerobics, swimming, sports games or carrying load >20 kg.
11 secondary outcomes
Compliance with the intervention
Time frame: 24 week of enrollment
Usability of mobile health program
Time frame: 24 week of enrollment
Maternal health outcomes: Pre-eclampsia
Time frame: Through study completion, average of 1 year
Maternal health outcomes: Gestational hypertension
Time frame: Through study completion, average of 1 year
Maternal health outcomes: Gestational Diabetes
Time frame: Through study completion, average of 1 year
Maternal health outcomes: Gestational weight gain during first, second and third trimester
Time frame: Through study completion, average of 1 year
Newborn birth weight
Time frame: Through study completion, average of 1 year
Newborn length
Time frame: Through study completion, average of 1 year
Preterm birth
Time frame: Through study completion, average of 1 year
Infant's Blood Pressure at 1 year
Time frame: 1 year of infant's age
Infant's Body Mass Index
Time frame: 1 year of infant's age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Derived from this study: PubMed 40203301Vadsaria K, Nuruddin R, Mohammed N, Azam I, Sayani S. Efficacy of a Personalized mHealth App in Improving Micronutrient Supplement Use Among Pregnant Women in Karachi, Pakistan: Parallel-Group Randomized Controlled Trial. J Med Internet Res. 2025 Apr 9;27:e67166. doi: 10.2196/67166.
- Derived from this study: PubMed 34783675Nuruddin R, Vadsaria K, Mohammed N, Sayani S. The Efficacy of a Personalized mHealth Coaching Program During Pregnancy on Maternal Diet, Supplement Use, and Physical Activity: Protocol for a Parallel-Group Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 16;10(11):e31611. doi: 10.2196/31611.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rozina Nuruddin principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Intervention in people with Pregnancy, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Risk Score (DRS) (time frame: 6 months, from enrollment till last follow-up). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04216446, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.