Mobile Health (m-Health) Coaching Program During Pregnancy

NCT04216446 | Completed DMC

• 1 other identifier: 2019-0757-2504
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

m-Health coaching; Pregnancy; Diet; Supplement use; Physical activity

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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

  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

  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

  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

  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.

  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.

  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.

  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.

  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.

  6 months, from enrollment till last follow-up

Secondary Outcomes (11)

• Compliance with the intervention

  24 week of enrollment

• Usability of mobile health program

  24 week of enrollment

• Maternal health outcomes: Pre-eclampsia

  Through study completion, average of 1 year

• Maternal health outcomes: Gestational hypertension

  Through study completion, average of 1 year

• Maternal health outcomes: Gestational Diabetes

  Through study completion, average of 1 year

Study Arms (2)

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.

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.

Interventions

Mobile Health Intervention BEHAVIORAL

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.

Mobile Health Coaching Program during pregnancy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

The Aga Khan University

Karachi, Sindh, 74000, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 40203301 DERIVED

• 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.

  PMID: 34783675 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Rozina Nuruddin

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 2, 2020
• Study Start: January 13, 2020
• Primary Completion: September 30, 2021
• Study Completion: June 30, 2023
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)