Effectiveness NutriDent4Mom to Improve Nutrient Intake, Diet Quality, and Periodontal Health Status of Pregnant Women

The Effectiveness of Mobile Application Prototype (NutriDent4Mom) in Improving Nutrient Intake, Diet Quality, and Periodontal Health Status of Pregnant Women: A Cluster Randomized Trial

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:

1. Does the NutriDent4Mom apps increase the mean nutrient intake (Nutrient value) and diet quality score (HEI) of pregnant women?
2. 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.

Study Overview

• Status: Completed
• Conditions: Periodontal Disease; Diet Quality; Nutrient Intake
• Intervention / Treatment: Behavioral: Mobile Application Prototype; Behavioral: Health education

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia
      • Ministry of Health Maternal and Child Health Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: Mobile Application Prototype; Participants were provided with the NutriDent4Mom application installed in their own mobile device. They were instructed to use the apps throughout the study period. The instructions include entering the daily food intake and reading the educational content. The participants must finish reading the content, which covers at least two topics per day, within one week. The mobile application usage was monitored by a usage counter, and participants also received reminders to record their diet intake into the application.
Active Comparator: 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"	Behavioral: Health education; Participants received health education delivered via health talk. Oral health care is one of the topics among other health topics including diet, breastfeeding, family planning, and preparation for delivery. These health education topics were delivered by the MOH medical staff nurses except for oral health care which was delivered by dental officers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrient Value	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.	From baseline to the end of intervention period at 8 weeks
Healthy Eating Index	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%.	From baseline to the end of intervention period at 8 weeks
Mean Gingival Index score	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.	From baseline to the end of intervention period at 8 weeks
Mean Community Periodontal Index score	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.	From baseline to the end of intervention period at 8 weeks

Collaborators and Investigators

• Sponsor: NORKHAFIZAH SADDKI
• Investigators: Principal Investigator: NORKHAFIZAH SADDKI, MCommMed (Oral Health) (USM), Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: pregnant women; mobile application; diet quality; periodontal health; nutrient intake
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases
• Other Study ID Numbers: USM/JEPeM/22020106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Ethical considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No