Mobile Health (m-Health) Coaching Program During Pregnancy

Aga Khan University

Status: Completed

Conditions: Pregnancy

Treatments: Behavioral: Mobile Health Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04216446

2019-0757-2504

Details and patient eligibility

About

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.

Full 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

Enrollment: 306 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

Mobile Health Coaching Program during pregnancy

Experimental group

Description:

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.

Treatment:

Behavioral: Mobile Health Intervention

Standard Counseling

No Intervention group

Description:

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.