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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 19 to 50 years
• Women only
• No healthy volunteers
• Adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Periodontal Disease, Nutrient Intake, Diet Quality

Being tested

Mobile Application Prototype, Health education

Keywords

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

Medical subject headings

Periodontal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Mobile Application PrototypeBehavioural

  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.

• Health educationBehavioural

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: From baseline to the end of intervention period at 8 weeks

2. 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%.

   Measured: From baseline to the end of intervention period at 8 weeks

3. 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.

   Measured: From baseline to the end of intervention period at 8 weeks

4. 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.

   Measured: From baseline to the end of intervention period at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted25 Nov 2025
2. Study start16 Nov 2022
3. Primary completion28 Feb 2023
4. Study completion28 Feb 2023

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.