Clinical trial NCT04216446: Mobile Health (m-Health) Coaching Program During Pregnancy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: m-Health coaching
Pregnancy
Diet
Supplement use
Physical activity
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 306
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

1. Pregnant women 18 years and above in their first trimester
2. Enrolled at antenatal clinics of The Aga Khan University Hospital, Karachi
3. Pregnant women who have personal smartphones with internet connections.
4. Eligible subjects who consent to participate and agree to remain in the study until the first year of the birth of the baby.

Exclusion Criteria:

1. Pregnant women who have co-morbidity such as cardiovascular disease, diabetes, liver or kidney disease or autoimmune disorder (SLE)
2. Pregnant women who are on dietary control due to co-morbid conditions.
3. Pregnant women who are on platelet aggregates, hypoglycemic or anti-hypertensive drugs.
4. Pregnant women who are unable to read and write due to the language barrier.

Primary outcomes:
measure: Dietary Risk Score (DRS)
timeFrame: 6 months, from enrollment till last follow-up
measure: Supplement use Score
timeFrame: 6 months, from enrollment till last follow-up
measure: Biochemical Assessment of serum folate at baseline
timeFrame: 1 week of enrollment
measure: Biochemical Assessment of serum ferritin at baseline
timeFrame: 1 week of enrollment
measure: Biochemical Assessment of serum calcium at baseline
timeFrame: 1 week of enrollment
measure: Biochemical Assessment of vitamin D at baseline
timeFrame: 1 week of enrollment
measure: Biochemical Assessment of serum folate at endline screening
timeFrame: 24 week of enrollment
measure: Biochemical Assessment of serum ferritin at endline screening
timeFrame: 24 week of enrollment
measure: Biochemical Assessment of serum calcium at endline screening
timeFrame: 24 week of enrollment
measure: Biochemical Assessment of Vitamin D at endline screening
timeFrame: 24 week of enrollment
measure: Physical activity
timeFrame: 6 months, from enrollment till last follow-up
Secondary outcomes:
measure: Compliance with the intervention
timeFrame: 24 week of enrollment
measure: Usability of mobile health program
timeFrame: 24 week of enrollment
measure: Maternal health outcomes: Pre-eclampsia
timeFrame: Through study completion, average of 1 year
measure: Maternal health outcomes: Gestational hypertension
timeFrame: Through study completion, average of 1 year
measure: Maternal health outcomes: Gestational Diabetes
timeFrame: Through study completion, average of 1 year
measure: Maternal health outcomes: Gestational weight gain during first, second and third trimester
timeFrame: Through study completion, average of 1 year
measure: Newborn birth weight
timeFrame: Through study completion, average of 1 year
measure: Newborn length
timeFrame: Through study completion, average of 1 year
measure: Preterm birth
timeFrame: Through study completion, average of 1 year
measure: Infant's Blood Pressure at 1 year
timeFrame: 1 year of infant's age
measure: Infant's Body Mass Index
timeFrame: 1 year of infant's age
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University
state: Sindh
Study officials:
affiliation: Assistant Professor
name: Rozina Nuruddin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nuruddin 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.