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

NCT07247019 | Completed

• 1 other identifier: USM/JEPeM/22020106
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontal Disease; Nutrient Intake; Diet Quality

Keywords

pregnant women; periodontal health; nutrient intake; diet quality; mobile application

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

NutriDent4Mom application

EXPERIMENTAL

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

Ministry of Health healthcare program for antenatal mothers

ACTIVE COMPARATOR

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

Interventions

Mobile Application Prototype BEHAVIORAL

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.

NutriDent4Mom application

Health education BEHAVIORAL

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.

Ministry of Health healthcare program for antenatal mothers

Eligibility Criteria

• Age: 19 Years - 50 Years
• Gender Eligibility Details: This study enrolled pregnant women. Therefore, only females are eligible to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NORKHAFIZAH SADDKI: lead

Study Sites (1)

Ministry of Health Maternal and Child Health Clinics

Kota Bharu, Kelantan, Malaysia

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• NORKHAFIZAH SADDKI, MCommMed (Oral Health) (USM)

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR DR.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 25, 2025
• Study Start: November 16, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: November 25, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)