The Effectiveness of Mobile Application Prototype (NutriDent4Mom) in Improving Nutrient Intake, Diet Quality, and Periodontal Health Status of Pregnant Women: A Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Mean Community Periodontal Index score
研究概览
简要总结
The goal of this two-arm, parallel-group cluster randomized controlled trial was to assess the effectiveness of a healthcare mobile application prototype (NutriDent4Mom) in improving nutrient intake, diet quality and periodontal health status of pregnant women.
The main questions it aims to answer are:
- Does the NutriDent4Mom apps increase the mean nutrient intake (Nutrient value) and diet quality score (HEI) of pregnant women?
- Does the NutriDent4Mom apps improve the periodontal health (GI score, CPI score) of pregnant women?
Researchers will compare the NutriDent4Mom apps to the conventional Ministry of Health (MOH) program to see if the NutriDent4Mom apps is effective to improve nutrient intake, diet quality and periodontal health status of pregnant women.
详细描述
Participants will receive the NutriDent4Mom application. Measurement of outcomes included the 3-day 24-hour diet recall for nutrient intake, Food Frequency Questionnaire (FFQ) for diet quality, and the Gingival Index (GI) and Community Periodontal Index (CPI) for periodontal health. Data were collected 3 times, at baseline before the respective intervention, after one month (evaluation 1), and after another one month (evaluation 2).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged from 19 to 50 years old
- •Pregnant between 13 to 20 weeks
- •Singleton pregnancy
- •Own any type of android operating system handheld device
- •Malaysian citizen
- •Able to read and write in Malay language
排除标准
- •Diagnosed with diabetes mellitus or gestational diabetes mellitus
- •Diagnosed with hypertensive disorder
- •Diagnosed with severe hyperemesis gravidarum during current pregnancy
- •Wearing dental appliances (removable and/or fixed appliance)
研究组 & 干预措施
NutriDent4Mom application
NutriDent4Mom mobile application provides comprehensive nutrition and oral health education with attractive application features that enable the engagement of behavioral changes in nutrient intake and oral health care
干预措施: Mobile Application Prototype (Behavioral)
Ministry of Health healthcare program for antenatal mothers
Routine antenatal healthcare provided by the MOH staff which include delivery of health education according to the topics specified in the Antenatal Mother Record Book or "Buku Rekod Kesihatan Ibu"
干预措施: Health education (Behavioral)
结局指标
主要结局
Mean Community Periodontal Index score
时间窗: From baseline to the end of intervention period at 8 weeks
Periodontal health status was measured using the Community Periodontal Index (CPI). The mouth was divided into 6 sextants (18-14, 13-23, 24-28, 38-34, 33-43, 44-48) and 10 index teeth (17, 16, 11, 26, 27, 36, 37, 31, 47, and 46) were examined using a CPI probe and given scores as follows: 0 = healthy periodontium, 1 = bleeding after probing, 2 = calculus detected during probing but the black band on the probe was visible, 3 = shallow pocket 4-5 mm (gingival margin within the black band on the probe), and 4 = deep pocket ≥ 6 mm (black band on the probe not visible). The highest CPI score of each patient was recorded, and the mean number of sextants having CPI code of 0, 1, 2, 3, and 4 was calculated to indicate the severity of periodontal disease.
Nutrient Value
时间窗: From baseline to the end of intervention period at 8 weeks
Nutrient intake was assessed using 24-hour diet recall. The 24-hour recall was done for 3 days (1 weekend and 2 weekdays) to establish intake of nutrients. Data were analysed using Nutritionist Pro™ software to establish the nutrient intake value. The nutrient values were compared with the Recommended Nutrient Intake (RNI) for pregnancy and categorised as follows: 1) Inadequate for values below the estimated average requirement, 2) Adequate for values between the estimated average requirement and tolerable upper intake level, and 3) Excessive for values exceed the tolerable upper intake level.
Healthy Eating Index
时间窗: From baseline to the end of intervention period at 8 weeks
Diet quality was assessed using a self-administered semi-quantitative food frequency questionnaire (FFQ). The FFQ comprises of 82 food items organized into 10 main food groups as follows: 1) Cereal and cereal products, 2) Meat and eggs, 3) Milk and milk products, 4) Nuts, 5) Vegetables, 6) Fruits and fruit juices, 7) Beverages, 8) Fats, 9) Sweet and baked goods, and 10) Condiments. The frequency of food intake has a 7-point scale rating as follows: 1=never or rarely, 2=once a month, 3=2 to 3 times a month, 4=once a week, 5=2 to 3 times a week, 6=once daily, and 7=2 to 3 times daily. The conversion factor was used to estimate food intake based on frequency of intake. The score of each food group was calculated using a validated formula. Diet quality was categorized as 1) Poor diet for score less than 51%, 2) diet requiring improvement for score 51 to 80%, and 3) Good diet for score more than 80%.
Mean Gingival Index score
时间窗: From baseline to the end of intervention period at 8 weeks
The Gingival Index (GI) was used to assess the severity of gingival inflammation. Four gingival areas of 6 index teeth (16, 12, 24, 36, 32 and 44) were examined using a CPI probe and given scores as follows: 0 = normal healthy gingiva; 1 = mild inflammation with slight colour change and oedema but no bleeding on probing; 2 = moderate inflammation with red, oedematous and glazing gingival tissues that bleed on probing; and 3 = severely inflamed gingival tissues with marked redness and oedema, ulceration, and tendency to bleed spontaneously. The scores from each index tooth were added and divided by 4 to give the GI for the tooth. The GI of each patient was determined by adding the scores for all index teeth and dividing it by the number of teeth examined.
次要结局
未报告次要终点
研究者
NORKHAFIZAH SADDKI
ASSOCIATE PROFESSOR DR.
Universiti Sains Malaysia
