Efficacy of Personalized Mobile-Health Coaching Program During Pregnancy on Maternal Diet, Supplement Use and Physical Activity: a Parallel-Group Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Supplement use Score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Supplement use Score
时间窗: 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 calcium at baseline
时间窗: 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 endline screening
时间窗: 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.
Dietary Risk Score (DRS)
时间窗: 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.
Physical activity
时间窗: 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.
Biochemical Assessment of serum folate at baseline
时间窗: 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
时间窗: 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 vitamin D at baseline
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Usability of mobile health program(24 week of enrollment)
- Infant's Blood Pressure at 1 year(1 year of infant's age)
- Maternal health outcomes: Gestational hypertension(Through study completion, average of 1 year)
- Maternal health outcomes: Gestational Diabetes(Through study completion, average of 1 year)
- Compliance with the intervention(24 week of enrollment)
- Maternal health outcomes: Pre-eclampsia(Through study completion, average of 1 year)
- Maternal health outcomes: Gestational weight gain during first, second and third trimester(Through study completion, average of 1 year)
- Newborn birth weight(Through study completion, average of 1 year)
- Infant's Body Mass Index(1 year of infant's age)
- Newborn length(Through study completion, average of 1 year)
- Preterm birth(Through study completion, average of 1 year)
研究者
Rozina Nuruddin
Assistant Professor
Aga Khan University